Nektar Therapeutics

Nektar Therapeutics San Francisco, CA, USA
Mar 28, 2020
Full time
Position Overview Overall responsibility for leading the safety surveillance and risk management of the assigned drug products in Nektar's development pipeline and for managing patient safety and meeting regulatory reporting requirements. Monitors and analyses evolving risk/benefit profile of the assigned products in various stages of clinical development to identify potential safety signals and implements appropriate safety monitoring and risk mitigation plans. Serves as medical safety expert for the assigned products in early and late stages of clinical development as well as in pre-IND stage products. Leads role to help respond to and resolve safety questions from regulatory authorities, investigators, internal development teams, and external development partners. Closely collaborates with various internal stakeholders such as clinical operation, clinical development, clinical pharmacology, regulatory affairs, biostatistics, data management, project management, toxicology teams as well as external development partners to ensure delivery of quality pharmacovigilance and meet all regulatory obligations and company SOP requirements. Leads or contributes to the development and preparation of periodic safety reports, response to safety-related queries from health authorities, investigator communications, and other ad hoc reports as necessary. Provides medical expert safety review and input into all critical documents for clinical development and regulatory filings of the assigned products, including investigational brochure, study protocol, informed consent form, briefing documents, clinical study report, risk management plan, product labeling, and IND/NDA packages. Conducts real-time medical review of individual clinical safety reports (ICSRs) received from ongoing clinical trials, including providing company causality assessment and similar-event analyses, and timely communicates AEs of special interest cases to clinical development teams. This position reports to the head of Drug Safety and helps select, develop, and train personnel to ensure the efficient operation of the drug safety function. This job contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs.Monitors and analyses evolving risk/benefit profile of the assigned products in various stages of clinical development to identify potential safety signals and implements appropriate safety monitoring and risk mitigation plans. Leads role to help respond to and resolve safety questions from regulatory authorities, investigators, internal development teams, external development partners, as well as regulatory agency audits and corrective action plans. Closely collaborates with various internal stakeholders such as clinical operation, clinical development, clinical pharmacology, regulatory affairs, biostatistics, data management, project management, toxicology teams as well as external development partners to ensure delivery of quality pharmacovigilance and meet all regulatory obligations and company SOP requirements. Leads the development and preparation of periodic safety reports (eg, DSUR and PSUR), response to safety-related queries from health authorities, investigator communications, and other ad hoc reports as necessary. Conducts real-time medical review of individual clinical safety reports (ICSRs) received from ongoing clinical trials, including providing company causality assessment and similar-event analyses, and timely communicates AEs of special interest cases to clinical development teams. Develops and/or negotiates safety contracts, safety data exchange agreement, interacts and coordinates activities of contract organizations or consultants for pharmacovigilance services as well as developmental/business partners. Provides ongoing advice to senior management (ad hoc or through periodic safety review committee meetings) on the changing risk-benefit profile of company drug products in clinical trials, based on analyses/evaluation of potential safety signals and implements appropriate safety updates and risk mitigation strategies. Provides medical expert safety review input into all critical documents for clinical development of the assigned products (eg. protocols and amendments, ICFs, IBs, IMPDs, clinical research reports, risk management plan, INDs, CTAs, NDAs/BLAs, briefing documents, etc). Establishes and manages independent Data Safety Monitoring Boards (DSMBs) or internal safety data monitoring committee for clinical studies, if required. Performs research on safety profiles of competitor products within therapeutic areas of interest to help develop effective competitive strategies, for clinical development of company drug products. An MD degree is required. A minimum of 7 years of experience in drug safety and risk management in clinical development setting is required. Experience and expertise in oncology product development and drug safety is highly desirable. An in-depth knowledge and thorough understanding of FDA and EU regulations, ICH guidelines, and GCPs that govern drug safety and pharmacovigilance are required. Experience and expertise in clinical safety assessments, safety signal detection and risk management, including interactions with regulatory authorities are required. Must be able to demonstrate extensive experience/knowledge in the design of clinical studies and have a strong working knowledge of safety reviews for input into critical documents for drug development. Experience in using safety database (e.g., Argus) to perform medical review of individual case safety report is highly desirable. Experience in preparing aggregate safety reports (eg, DSUR, PSUR/PBRER) is required. Ability to research and understand the safety profiles of competitor products within therapeutic areas of interest to help develop effective competitive strategies, as well as an in-depth understanding of clinical product development in the pharmaceutical/biotech industry. Strong oral and written communication skills are required. Must have a demonstrated ability to solve problems with innovative solutions along with strong organizational skills. Strong analytical skills, especially with regard to understanding and interpreting scientific research and literature are essential. Must be a demonstrated self-starter and team player with strong interpersonal skills. Must have strong computer skills with a proficiency in various software applications (eg. Microsoft Project, Word, Excel, PowerPoint). We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.
Nektar Therapeutics San Francisco, CA, USA
Mar 28, 2020
Full time
Position Overview The Computer Validation Specialist III is a key position within the Nektar IT organization whose primary responsibility is to assist IT management in ensuring the activities of the IT group are in compliance with SOX and cGxP control requirements. The three primary duties this individual must fulfill to meet this responsibility are that of:, a) SOX Administrator, b) Document Administrator and c) Department Training Coordinator (DTC). As member of the IT team, this individual is also responsible to take a proactive posture to evolving procedures and practices to support new technology and change in business requirements. This position contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs. Document Administrator Responsibilities: Maintains multiple record types (log books, excel spreadsheets, physical documents, etc.) of all Change Requests (CRs), issuing new change request numbers to IT staff as requested. Reviews all CRs for compliance with applicable SOX, cGxP and IT quality requirements, routing only those CRs that meet those requirements. Ensures the Change Review Board (CRB) meets as required and all identified issues from the CRB are followed up on. Provides updates on the status of Open Change Requests to IT Management on a periodic basis. Supports and performs IT Quality document control activities in order to ensure compliance within the controlled document management system both electronically and manually. Maintains multiple record types (excel spreadsheets, document lifecycle versions, as well as physical and electronic copies, etc.) of all IT Quality Documents (ITQDs) including, but not limited to i) IT quality system level documents, ii) IT arrangements, iii) access forms, and iv) IT system level passwords. Reviews all ITQDs for compliance with applicable SOX, cGxP and IT quality requirements, routing only those ITQDs that meet the requirements. Assists in gathering and generating the system access review and document access review reports/memos on a periodic bases. Provides guidance and assists IT staff to meet applicable ITQD requirements as time permits, and reviews and suggest revisions to ITQDs to help streamline IT operational efficiency. Performs periodic review of SOPs and updates and routes SOPs, if needed. SOX Administrator Responsibilities: Maintains, revises and issues the IT General Computer Controls (IT GCC) and associated tests for these IT GCC's on an annual basis based on input from annual SOX Testing, IT Management and external audit results. Ensures the IT GCC's are performed throughout the year escalating to IT mangement as needed. Maintains and organizes the results of all IT GCCs to ensure accessibility is readily available to IT management at all times and as needed. Assists in teh preparation of IT GCCs, and performs extensive annual IT GCC testing and reviews results with Nektar internal audit, preparing follow-up procedures on internal audit recommendations. Department Training Coordinator (DTC) Responsibilities: Generates monthly/quaterly training reports and follows up with the defaulters. Assigns training to new employees and vendors and ensures completion. May provide training to new employees and help maintain the Training program by updating training cirriculums. Other Responsibilities include: Responsible for the performance and monitoring of certain daily IT systems such as backup tape media rotation and offsite storage, review of the IT monitoring system for low level non-critical alerts and communication to IT staff as appropriate, and physical inspection of the server rooms to ensure that all audible and visual alarms are taken care of. Prepares IT policies, practices, and procedures for the IT staff. May help develop policy management standards. Performs special projects as assigned. Performs other duties as assigned. A Bachelor's degree in a relevant discipline is preferred. Equivalent experience may be accepted. A minimum of 5 years work experience in a compliance or related role is required. Experience with systems like MasterControl, Veeva QualityDocs, ValGenesis and ServiceNow considered a plus. Must be a quick learner, team player, and possess outstanding organizational skills. Very good analytical and problem solving skills are required. Strong skills in computer applications (MS Office, Word, Excel, Project) are required. Great interpersonal skills, with a focus on listening and questioning skills are required. Must possess excellent oral and written communication skills. Must be able to follow instructions and work well in a team environment. Experience in the Pharmaceutical, Biotech or Medical Product industry is preferred. Excellent customer service skills are required. Must have an excellent understanding of IT, SOX, and cGxP terminology and concepts. Some understanding of application processing and system development control techniques and related auditing techniques is preferred. Must be familiar with system design, computer operations, disaster recovery, data security and program change control. Familiarity with authentication and authorization architectures is preferred. Familiarity with internal controls as related to financial systems or FDA-related policies is preferred. Must have the ability to formulate and express ideas relating to difficult and highly technical concepts. Knowledge of project mangement methodologies is preferred. Previous experience with system implementations is preferred. Must possess good planning, decision making and judgement skills. We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.
Nektar Therapeutics San Francisco, CA, USA
Mar 28, 2020
Full time
Position Overview This is a key position in the application implementation groups of the Nektar IT organization. This position will be responsible for the management of the selection, implementation, and ongoing maintenance of families of interrelated applications and systems supporting Nektar's various departments (Research, Drug Development, PDM, Finance, HR, Quality, Supply Chain, etc.). This position will also serve as an IT leader in collaborating with business partners to define the immediate, intermediate and long term solutions to the business's needs, as defined by the mutually determined business requirements. This position will manage multiple projects and programs and will collaborate closely with various business departments, cross-functional teams and our SaaS vendors. Finally this position will provide leadership in system delivery/implementation, regulatory compliance (SOX, GxP, etc.) within Nektar's SLC framework, tools and procedures. This position contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs. Works on significant and unique issues where analysis of situations or data requires an evaluation of intangibles. Exercises independent judgment in methods, techniques and evaluation criteria for obtaining results. Creates formal networks involving coordination among groups. Develops project plans, organizes and leads project teams, monitors progress and drives the delivery with focus on adhering to schedule. Facilitate sessions for use-cases, requirements gathering and configuration workshops, as necessary. Develops or reviews the necessary documentations (e.g. CapEx, Statement of Work, Service Level Agreement, Stakeholder Requirements, Functional Requirements, detailed schedule and budget and necessary SOP's). Leads and monitors the planning, deployment or required upgrades of Nektar systems, in support of Nektar's stated business objectives. Drives and coordinates system related Change Requests, Deviations / CAPA's and audits in accordance to governing SOX and GxP procedures. May participate in product evaluations (RFP/RFI), vendor selection, negotiates price and support options, and fosters vendor partnerships. Responsible for maintaining the validated and compliant state of all applications to ensure compliance to regulatory standards. Coordinates the implementation of enhancements/upgrades and provides backup for other IT SME ' s as required. Responds to critical issues during off hours when necessary. Work closely with the IT platform leads to apply standards and evolve process to ensure solutions abide by best practices and industry standards. Other duties as assigned. Creates formal networks involving coordination among groups. A minimum of a Bachelors' degree in Computer Science, Information Technology, or related discipline. is required. An advanced degree is highly preferred. Equivalent experience may be accepted. Certification in Project Management is preferred. A minimum of 12 years of relevant experience is required, which includes a minimum of 6 years of project management experience. Strong knowledge of procedures/ best practices related to FDA Regulations, SOX, EU GMP Annex 11, 21 CFR Part 11, Computer System Validation, GAMP 5, cGxP (cGCP, cGLP, cGMP) practices required. Familiar with system lifecycle (SLC) experience in a regulated environment. Familiar with Operating Systems, Infrastructure, VMWare Virtualization, and cloud-hosted technologies. Ability to articulate technical problems and business value to a wide business audience. Ability to troubleshoot issues and work independently with minimal supervision. Must be able to demonstrate strong analytical and problem-solving capabilities. Detail oriented and a hands-on PM, driving successful delivery of projects ensuring positive customer satisfaction. Excellent oral and written communication skills are required. Must possess and demonstrate strong leadership, influencing and organizational skills. Self-motivated with high degree of initiative and excellent follow-up skills. We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.
Nektar Therapeutics San Francisco, CA, USA
Mar 27, 2020
Full time
Position Overview Oversees the direction, planning, execution, and interpretation of clinical trials/research and the data collection activities. Summary: Oversees the direction, planning, execution, and interpretation of clinical trials/research and the data collection activities. Establishes and approves scientific methods for design and implementation of clinical protocols, data collection systems and final reports. Participate in recruitment of clinical investigators and negotiations on study design and costs. Responsible for directing human clinical trials, Phases I IV for company products under development. Coordinates and develops reporting information for reports submitted to the FDA. Monitors adherence to protocols and determines study completion. May act as consultant or liaison with other corporations when working under licensing agreements. May select, develop, and evaluate personnel to ensure the efficient operation of the function. This job contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs. Essential Duties and Responsibilities: Consistently works on abstract problems across functional areas of the business. Identifies and evaluates fundamental issues, providing strategy and direction for major functional areas. Interacts internally and externally with executive level management requiring negotiation of extremely difficult matters to influence policymaking bodies. Ensures budgets, schedules and performance requirements are met. Identifies, evaluates and provides Clinical Scientific Leadership to resolution of issues related to development activities for major functional areas. Interacts internally and externally with senior level management on critical development matters that influence policymaking. Responsible for the development and management of Clinical Development Materials (Protocols, Regulatory Submission. Etc.) which include timelines, budgets and resource requirements. Develops and implements clinical program strategy and provides cross-functional leadership in order to meet Company goals and objectives. Participates in corporate development of methods, techniques and evaluation criteria for projects, programs and people. Supports Senior Management in directing the design of pivotal clinical studies for product and registration. Identifies and develops collaborations with external investigators and opinion leaders. Responsible for working closely with Nektar internal functions, such as Regulatory Affairs, Clinical Operations, Marketing and Business Development. Provides clinical analysis and promulgates scientific and clinical support for expansion of market share of Company products. Provides support to the business in the development of promotional materials and the training of product representatives. Provides Clinical Scientific leadership the development of publications arising from studies and other relevant initiatives. Acts as a mentor to junior staff. Remains current with medical developments and publications on similar and competitor products. Applies this knowledge to current programs. May have responsibility for internal staffing and performance management, including hiring, training, coaching and performance reviews. Minimum Qualification Requirements: A minimum of a Bachelor's degree in a scientific discipline is required. An MD degree is also required. A minimum of 9 years relevant clinical science/medical affairs experience is required. Must be able to demonstrate extensive experience in the design of clinical studies. A minimum of 7 years previous management experience may be required. Must have a demonstrated ability to solve problems with innovative solutions along with strong organizational skills. Excellent written and verbal communication skills are required. Previous experience working with senior management is required. Experience in conducting formal presentations to Sr. Management and key opinion leaders in required. Must have knowledge of effective competitive strategies as well as an in-depth understanding of clinical product development in the pharmaceutical industry. Strong analytical skills, especially with regard to understanding and interpreting scientific research and literature are essential. Experience and understanding of ICH, and GCP is required. Knowledge of GMP and GLP is preferred. Must be a demonstrated self-starter and team player with strong interpersonal skills. Must have strong computer skills with a proficiency in Microsoft Project, Word, Excel, Visio, and PowerPoint. We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.
Nektar Therapeutics San Francisco, CA, USA
Mar 27, 2020
Full time
Position Overview Receives and directs visitors, employment applicants, vendors and customers to appropriate locations and parties. Typically operates a single or multiple position telephone system. Maintains a visitors' log and issues badges when necessary. Notifies personnel of visitor arrival. Will perform administrative work such as word processing and data entry and work with other facilities operational systems. Additional duties will include filing, sorting, mail distribution and completing special administrative projects. Applies acquired job skills and company policies and procedures to complete assigned tasks. Works on assignments that are semi-routine in nature but recognizes the need for occasional deviation from accepted practice. Normally follows established procedures on routine work, requires instructions only on new assignments. Answers the company telephone and greets visitors. Maintains visitor logs and issues temporary badges. Maintains the master telephone extension list. Performs miscellaneous administrative work, including database input, outlook calendaring, distributing facilities work orders via computer system, and provides other support to facilities as required. Maintains vendor and emergency contact lists. Maintains reception area in an orderly and professional fashion. Generates name strips for mail slots and cube location labeling. May assist in issuing keycards, along with auditing the key card database on a monthly basis. Performs other administrative duties as required. Requires a minimum of a High School diploma. Equivalent experience may be accepted. A minimum of 2 years industry experience in office services is required. Experience working in the Pharmaceutical or Biotechnology industry is a plus. Good communication skills both oral and written are a must. Excellent customer service skills are a must. Good computer skills are required. Excellent organizational skills are required. Must have an ability to multi-task. Attention to detail and follow through in completing assignments/projects is a must. Proficient knowledge in the use of Microsoft Suite such as Outlook, Word, Excel, PowerPoint, and other applications is a must. Must demonstrate an ability to learn new systems and software programs quickly. Outstanding customer service skills are required. We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.
Nektar Therapeutics San Francisco, CA, USA
Mar 27, 2020
Full time
Position Overview Nektar Therapeutics has an exciting opportunity for a motivated Sr. Administrative Assistant who will provide administrative support to the Vice President, Information Technology and IT team. We are looking for a professional, take charge Assistant to keep business operations organized, on track and moving forward. Candidates must possess strong communication skills, both written and oral, the ability to multi-task efficiently in a fast-paced environment, and the ability to work independently with initiative, discretion and confidentiality. Performs administrative tasks such as calendaring, scanning, filing, and scheduling of appointments, meetings, and conference calls. Will also be responsible for off-site events, catering and coordinating and implementing travel. Ensures that Executive's productivity is enhanced by managing calendars and schedules, including management of expense reports. Must have the ability to manage multiple high priority assignments. Fosters and maintains strong working relationships within all levels of the company, as well as with outside vendors and contacts. Creates and/or modifies presentations as needed. Works on assignments that are complex in nature and require considerable judgment, initiative and specialized knowledge to resolve problems and/or develop recommended solutions. Work is completed with minimal supervision, assignments are of the highest quality, and follow-through is outstanding. An Associate and/or a Bachelors degree or other relevant professional certification is a plus. Equivalent experience may be accepted. A minimum of 6 years senior level Administrative Assistant experience is required. Must have proven track record of supporting senior level executives. Demonstrated ability to establish priorities and act quickly and professionally. Must be flexible with ability to multi-task assignments. Excellent organizational and problem solving skills are required. Excellent verbal and written communication skills are required. Attention to detail and follow through in completing assignments/projects is a must. Thorough knowledge in the use of Microsoft Office suite (Word, PowerPoint, Excel) is required. Outstanding and advanced PowerPoint skills. Outstanding customer service skills. Demonstrate ability to handle sensitive information, which has tactical and strategic importance. Ability to work independently with discretion and confidentiality. We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.
Nektar Therapeutics San Francisco, CA, USA
Mar 27, 2020
Full time
Position Overview Receives and directs visitors, employment applicants, vendors and customers to appropriate locations and parties. Typically operates a single or multiple position telephone system. Maintains a visitors' log and issues badges when necessary. Notifies personnel of visitor arrival. Will perform administrative work such as word processing and data entry and work with other facilities operational systems. Additional duties will include filing, sorting, mail distribution and completing special administrative projects. Applies acquired job skills and company policies and procedures to complete assigned tasks. Works on assignments that are semi-routine in nature but recognizes the need for occasional deviation from accepted practice. Normally follows established procedures on routine work, requires instructions only on new assignments. Answers the company telephone and greets visitors. Maintains visitor logs and issues temporary badges. Maintains the master telephone extension list. Performs miscellaneous administrative work, including database input, outlook calendaring, distributing facilities work orders via computer system, and provides other support to facilities as required. Maintains vendor and emergency contact lists. Maintains reception area in an orderly and professional fashion. Generates name strips for mail slots and cube location labeling. May assist in issuing keycards, along with auditing the key card database on a monthly basis. Performs other administrative duties as required. Requires a minimum of a High School diploma. Equivalent experience may be accepted. A minimum of 2 years industry experience in office services is required. Experience working in the Pharmaceutical or Biotechnology industry is a plus. Good communication skills both oral and written are a must. Excellent customer service skills are a must. Good computer skills are required. Excellent organizational skills are required. Must have an ability to multi-task. Attention to detail and follow through in completing assignments/projects is a must. Proficient knowledge in the use of Microsoft Suite such as Outlook, Word, Excel, PowerPoint, and other applications is a must. Must demonstrate an ability to learn new systems and software programs quickly. Outstanding customer service skills are required. We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.
Nektar Therapeutics San Francisco, CA, USA
Mar 26, 2020
Full time
Position Overview The Biologics Purification & Manufacturing team is looking to hire a Sr. Scientist, Biologics Purification. Summary: Nektar biologics CMC organization is seeking a highly motivated and experienced professional as a Senior scientist of Analytical Development, Quality Control and CMC. The ideal candidate has demonstrated knowledge in Analytical Development of biologics and familiarity with PEGylated Drug Substance and Drug Product. This position will collaborate closely with internal cross-functional departments with representatives from bioassay development, analytical method development/characterization, process development, manufacturing operations, quality assurance, project management and regulatory affairs to achieve corporate goals and objective. This position will also require working closely with multiple external contract organizations including CMOs and Contract Laboratories in the areas of method transfer, qualification/validation and implementation of QC methods, with focus on plate-based and cell-based potency methods for lot release and stability studies. The successful candidate must be proficient in biological assay development (ELISA and cell-based) and be proficient in Quality Control execution and systems, stability study programs, method development/qualification/validation, and end to end CMC regulatory drug approval process for biologic drug substances and drug products. We seek a self-starter with the ability to work independently under minimal supervision, and who is looking to be part of an authentic, innovative and fast-paced team. The ideal candidate will be instrumental in bringing the company's therapeutic products from early-discovery development stage to commercial launch and be a critical part of creating an innovative team for the development of the company's next generation products. Responsibilities: Work closely with the method development team and provide strategic guidance on potency method selection, development, qualification/validation, technical transfer and troubleshooting. Manage specification setting and stability programs for clinical and commercial products in accordance with ICH/FDA/EMA/USP/Ph. Eur. Guidelines. Oversight and management of contract testing organizations engaged in analytical development and quality control activities. Provide technical review of analytical data integrity and laboratory documentation, method development reports and method qualification/validation protocols and reports. Author, update, and revise CMC sections to support regulatory filings. Address CMC comments in responses from regulatory agencies. Ensure compliance with cGMP such that the products are assessed to agreed-upon specifications in a timely manner in order to support in-process, lot release and stability testing. Participate in deviation investigations and CAPA implementation in support of CMC QC projects and improvement. Support inspections/audits (regulatory and internal) and draft audit observation responses.Proactive engagement to identify projects and areas for continuous improvement purposes. Requirements: Master's degree in Chemistry, Biochemistry or a related life science field; PhD degree is highly desirable. Working experience with a minimum of 8 years in analytical development and/or GMP testing (Pharmaceutical or Biotechnology industries) with primary focus on the development, tech transfer andqualification/validation of bioassays (including, but not limited to, ELISA, enzyme activity, cell-based potency methods) Technical knowledge in protein chemistry and analytical chemistry, and in the development and implementation of general and protein-specific analytical methods is desirable. Excellent oral and written communication skills, auditing skills, and proven ability to work autonomously and manage effectively in a matrix environment. Proficient in project and personnel management, excellent organizational skills, and the ability to work on multiple projects with tight timelines. Excellent interpersonal and verbal communication skills, and with ability to influence and liaise in a dynamic cross-functional matrixed team environment. Proficiency in MS Office, Word and Excel - Proficiency in statistical analysis software is desirable We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.
Nektar Therapeutics San Francisco, CA, USA
Mar 26, 2020
Full time
Position Overview Nektar Therapeutics has an exciting opportunity for a motivated Sr. Executive Assistant who will provide administrative support to the Chief Commercial Officer and Commercial Leadership Team. We are looking for a professional, take charge Sr. Executive Assistant to keep business operations organized, on track and moving forward. Candidates must possess strong communication skills, both written and oral, the ability to multi-task efficiently in a fast paced environment, and the ability to work independently with initiative, discretion and confidentiality. Performs administrative tasks such as calendaring, scanning, filing, and scheduling of appointments, meetings, and conference calls. Will also be responsible for off-site events, catering and coordinating and implementing domestic & international travel. Ensures that Executive's productivity is enhanced by managing calendars and schedules, including management of expense reports and time cards. Must have the ability to manage multiple high priority assignments. Fosters and maintains strong working relationships within all levels of the company, as well as with outside vendors and contacts. Creates and/or modifies presentations as needed. Works on assignments that are complex in nature and require considerable judgment, initiative and specialized knowledge to resolve problems and/or develop recommended solutions. Work is completed with minimal supervision, assignments are of the highest quality, and follow-through is outstanding. An Associate and/or a Bachelors degree or other relevant professional certification is a plus. Equivalent experience may be accepted. A minimum of 8 years senior level Administrative Assistant experience is required. Must have proven track record of supporting senior level executives. Demonstrated ability to establish priorities and act quickly and professionally. Must be flexible with ability to multi-task assignments. Excellent organizational and problem solving skills are required. Excellent verbal and written communication skills are required. Attention to detail and follow through in completing assignments/projects is a must. Thorough knowledge in the use of Microsoft Office suite (Word, PowerPoint, Excel) is required. Outstanding and advanced PowerPoint skills. Outstanding customer service skills. Demonstrate ability to handle sensitive information, which has tactical and strategic importance. Ability to work independently with discretion and confidentiality. We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.
Nektar Therapeutics San Francisco, CA, USA
Mar 26, 2020
Full time
Position Overview The Manager, Clinical Data Management leads the data management components of a clinical trial ranging from small early phase to large global and late phase programs. The Manager, Clinical Data Management is responsible for ensuring study launch, conduct, and closeout are performed according to Nektar's quality standards, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), and International Conference on Harmonization (ICH) guidelines to fulfill all federal and local regulations. The assigned clinical trial(s) may be high complexity or high risk. Duties include serving as the primary data management liaison with vendors and senior management. This position will manage essential duties and responsibilities as independently as possible, with guidance and oversight provided by senior data management when needed. This job contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs. Maintain effective communication with vendors and Nektar's internal project team through oral and written correspondence, project status and progress reports. Manage the planning, implementation and overall direction of executing clinical trial data management activities including protocol review, electronic system configuration, Case Report Form (CRF/eCRF) design, database development, validation programming, and discrepancy management. Prepare information for internal meetings. Maintain and evaluate project progress by managing timelines and other tracking/analysis tools. Design, produce and distribute standard and customized status, resourcing, and tracking reports as well as functional area plans, to appropriate team members and senior management. Work on problems of a diverse scope. Exercise judgment in managing tasks within generally defined practices and policies in selecting methods and techniques to track and manage timelines, risk, and data quality. Manages the cross-functional collaboration, development, and maintenance of the components of the study Data Management Plan (DMP) and data management deliverables including the Case Report Form (CRF), CRF completion guidelines, SAS annotated CRFs, data handling plan, data review plan, edit check specifications, data transfer specifications, data quality plan, etc. Manage the interaction with data management vendors to ensure that data management tasks remain on target according to project timelines. Proactively organize on-going data review throughout the conduct of the study to ensure timely and appropriate identification of errors and discrepancies. Facilitate the correction of errors and discrepancies through the site query process, document permanent data issues, communicate issues with team members, and deliver a quality locked database for analysis. Provide input to the data management study budget and responsible for managing assigned vendor budget(s). Lead new data management initiatives such as establishing capacity for electronic data capture and clinical outcome assessments. Conduct CRO data management function inspections and audits. Contribute to the development and implementation of departmental policies, standards and process improvement initiatives. May mentor and develop junior data management staff. A bachelor's degree in clinical, biological or mathematical sciences, nursing degree, or equivalent related field education and experience is required. A master's degree is preferred. A minimum of 8 years actively managing clinical research projects in collaboration with other functional areas with at least 2 years successfully managing CROs is CROs is preferred. Previous supervisory, oncology and/or central nervous system experience is preferred. A thorough knowledge of FDA regulations, drug development and clinical monitoring procedures is required. Demonstrated problem solving abilities and strong presentation, documentation, organizational, and interpersonal skills as well as a team-oriented approach are required. Excellent written and verbal communication skills are required. Demonstrated proficiency with ICH, GCDMP, and GCP is required. Fluent English is required. Proficient computer skills using Word, Excel, PowerPoint, MS Project, email and the internet are required. Demonstrated self-starter with the ability to mentor and handle multiple tasks to meet deadlines while delivering high quality work in a dynamic work environment. Must possess excellent project management skills and have demonstrated ability to develop data management processes and training. Previous people management experience is preferred. We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.
Nektar Therapeutics San Francisco, CA, USA
Mar 26, 2020
Full time
Position Overview A senior leader, overseeing the direction, planning, execution, and interpretation of clinical trials/research and the data collection activities. Establishes and approves scientific methods for design and implementation of clinical protocols, data collection systems and final reports. May recruit clinical investigators and negotiates study design and costs. Responsible for directing human clinical trials, phases I through IV for company products under development. Responsibilities also include adverse event reporting and safety responsibilities monitoring. Coordinates and develops reporting information for reports submitted to the FDA. Overall responsibility for adherence to protocols and determines study completion. May act as consultant/liaison with other corporations when working under licensing agreements. May select, develop, and evaluate personnel to ensure the efficient operation of the function. Oversees the development and management of Clinical Development Plans (CDP) which includes timelines, budget and resource requirements. Ensures the development and implementation of clinical program strategy and directs those systems and programs in order to meet Company goals and objectives. May create and chair the Medical Advisory Board for proprietary products. Oversees the design of pivotal clinical studies for product and registration. Identifies and develops collaborations with external investigators and opinion leaders. Responsible for working closely with groups such as, Clinical Research, Regulatory Affairs, Clinical Operations, Marketing and Business Development. Acts as a clinical opinion leader working with physicians at a peer level. Oversees and coordinates efforts to address medical and scientific issues. Provides clinical analysis and promulgates scientific and clinical support for expansion of market share of Company products. Provides guidance to the business in the development of promotional materials and the training of product representatives. Oversees and performs medical monitoring. Drives the development of publications arising from studies and other relevant initiatives. Acts as a mentor to junior staff. Remains current with medical developments and publications on similar and competitor products. Applies this knowledge to current programs. May have responsibility for internal staffing and performance management, including hiring, training, coaching and performance reviews. A minimum of a Bachelors degree in a scientific discipline is required. An MD degree is also required. A minimum of 15 years relevant clinical science/medical affairs experience is required. Must be able to demonstrate extensive experience in the design of clinical studies. A minimum of 8 years previous management experience may be required. Must have a demonstrated ability to solve problems with innovative solutions along with strong organizational skills. Excellent written and verbal communication skills are required. Previous experience working with senior management is required. Experience in conducting formal presentations to Sr. Management and key opinion leaders in required. Must have knowledge of effective competitive strategies as well as an in-depth understanding of clinical product development in the pharmaceutical industry. Strong analytical skills, especially with regard to understanding and interpreting scientific research and literature are essential. Experience and understanding of ICH, and GCP is required. Knowledge of GMP and GLP is preferred. Must be a demonstrated self-starter and team player with strong interpersonal skills. Must have strong computer skills with a proficiency in Microsoft Project, Word, Excel, Visio, and PowerPoint. We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.
Nektar Therapeutics San Francisco, CA, USA
Mar 26, 2020
Full time
Position Overview The Scientist, Biologics Analytical Development, is part of Nektar's Biologics CMC organization. Scientist, Biologics Analytical Development, part of Nektar Biologics CMC organization is responsible for product characterization, analytical method development/validation of proteins and protein-conjugates for Nektar Biologic products in pre-clinical and clinical development stages. The candidate will collaborate with other groups on analytical issues, develop testing methodologies to support process development of drug substance and drug product. This candidate should have the ability to independently plan, design, and implement protocols to successfully solve issues related to protein characterization. This is a hands-on bench position, focused on sample preparation, mass spectrometry-based data acquisition, instrument maintenance/troubleshooting and data analysis. Responsibilities: The candidate will develop and validate analytical methods to support late stage drug development activities, including assisting process development scientists to characterize and monitor in-process purification. The individual will be responsible for the whole workflow from sample preparation to data analysis. Perform sample preparation including digestion mapping of regular proteins and protein polymer conjugates Analyze intact proteins and digested peptides following SOP and develop new methods using LC-MS/MS Analyze data to share with collaborators Maintain and troubleshoot Thermo Orbitrap mass spectrometers and Waters UPLC Write and review internal reports, in addition to presenting results and experimental information to departmental colleagues Requirements: Requires a PhD in a scientific discipline and a minimum of 2+ years industrial experience, may include post-doctoral experience.Exceptional non-PhDs with demonstrated capabilities and/or significant experience may also be considered Extensive expertise in developing LC-MS/MS based protein characterization methods such as proteomics and peptide mapping. 2 + years of experience on Thermo Orbitrap mass spectrometer is highly desired Hands-on experience on sample preparation for mass spectrometry-based analysis of proteins Experience in maintaining and troubleshooting UPLC and mass spectrometers Experience in HPLC separation methods such as ion exchange, reversed phase, and size exclusion chromatography, and capillary electrophoresis for proteins is a plus Strong communication skills and exemplary attention to detail We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.
Nektar Therapeutics San Francisco, CA, USA
Mar 25, 2020
Full time
Director, External Manufacturing Biologics Location San Francisco Requisition Number 3556-394-R Apply Now Position Overview The Director, External Manufacturing works with CMC project leaders and Senior Management to provide oversight on all aspects of GMP manufacturing activities. The Director, External Manufacturing works with CMC project leaders and Senior Management to provide oversight on all aspects of GMP manufacturing activities for several Biologics clinical programs at contract manufacturing sites (CMO's). This includes ensuring adherence to project timelines and budget at CMO sites for uninterrupted supply of clinical trial material. Works on complex issues where analysis of situations or data requires an in-depth knowledge of the company. Participates in corporate development of methods, techniques and evaluation criteria for projects, programs, and people. Ensures budgets and schedules meet corporate requirements. Networks with key contacts outside own area of expertise. Works in a cross-functional team consisting of internal and external partners to ensure effective application of process technologies at CMO sites. Facilitates technology transfer between organizations and sites to meet required project goals. Ensures timely routing and review of all master batch records and deviation reports. Manages Drug Substance manufacturing activities at CMOs; including, but not limited to: routing of contracts for approvals internally and externally, assisting with scheduling of process development activities and GMP manufacturing campaigns, directing shipment of samples and finished products between sites, tracking project timelines and action items. Travels to contract management site or business partners, as required, both domestic and international up to 50%. Ensures product integrity and company reputation by assisting in the monitoring of cGMP compliance at all times. Is responsible for issuing requests for proposals for manufacturing and analytical services per program requirements and negotiating CMO fees/payment schedules. Bachelor's degree in a scientific discipline with minimum of 13+ years of experience in the pharmaceutical industry and 10+ years of management experience. Expertise in biopharmaceutical process development, GMP manufacturing with exposure to external partnership management is required. Frequent domestic and international travel required. Prior experience with technology transfer and providing oversight to CMOs desired. Excellent written and verbal communications and teamwork skills are essential. Must be goal oriented, quality conscientious, and customer focused. Project management experience is a plus. We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.
Nektar Therapeutics Huntsville, AL, USA
Mar 24, 2020
Full time
Position Overview The Director, Analytical Development will direct the activities of an analytical development group in the research and/or development of an organization's products, projects and programs. Conducts and collaborates with others on analytical chemistry issues relevant to long-term objectives and concerns. Develops and directs testing methodologies to control production intermediates, API and finished products. Develops strategies to ensure effective achievement of scientific objectives. Monitors and evaluates completion of tasks and projects. Develops budgets for capital expenditures, outsourced activities, and labor. Participates with other top managers to establish company policies. Makes final decisions on administrative or operational matters. Selects, develops, and evaluates personnel to ensure the efficient operation and cGMP compliance of the function. This position contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs. Works on abstract problems across functional areas of the business. Identifies and evaluates fundamental issues for major functional areas through assessment of intangible variables. Interacts internally and externally with executive level management, requiring negotiation of extremely difficult matters to influence policymaking bodies. Implements established and newly developed technologies in current and future generation products. Integrates and maximizes the contribution of science and technologies to the development process. Establishes goals, assists in the structuring of experiments, analyzes and reduces data, recommends and plans actions to achieve project objectives. Works in conjunction with functional teams to transfer and implement science/technology. Communicates cross-functionally with groups such as process sciences, formulation development, manufacturing and other groups to ensure appropriate project advancement. Supports the transfer of technology to contract service providers as appropriate. Maintains a current knowledge of latest technological/scientific trends. Hires and trains staff at appropriate levels of need, coordinates annual reviews, and counsels junior staff on career related subjects. Provides scientific/technical guidance, leadership and decision-making as appropriate. Maintains a thorough working knowledge of and champions the efficient execution of cGMP, as related to analytical activities in the pharmaceutical industry. A minimum of a Bachelor's degree in a scientific or engineering discipline is required. An advanced degree is highly desired. Equivalent experience may be accepted. A minimum of 13 years experience in the pharmaceutical or biotechnology industry is required. A minimum of 10 years previous management experience is required. Expertise in pharmaceutical research /development and cGMP, especially pertaining to small molecule drugs, is essential. Experience in collaboration with and oversight of contract service providers, especially contract manufacturers and contract testing facilities, is highly desirable. Experience in writing scientific and regulatory documents is required. Knowledge of advanced statistical techniques, such as data trend analysis and design of experiments, is highly desirable. Strong verbal and written communication skills are required. Project management skills are required. Requires the ability to influence or gain acceptance of others in sensitive situations. Must have a demonstrated ability to work with senior management. A proven ability to develop and manage to a budget is a must. Must be goal-oriented, quality-conscientious, and customer-focused. Good laboratory compliance and safety practices are a must. Demonstrated ability to develop successful relationships with and influence customers, both internal and external. Understands how to set expectations and negotiate proper milestones to track progress. Physical Requirements: Performance of tasks essential to the job function may require the employee to work directly with, handle, or otherwise come into contact with chemicals or pharmaceutical agents. Employees may be required to enroll in a medical surveillance program based on the potential exposure to certain health hazards encountered as a result of their job function. We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.
Nektar Therapeutics San Francisco, CA, USA
Mar 24, 2020
Full time
Position Overview The Associate Director, Clinical Operations will manage all aspects of clinical operations for assigned project(s). This includes contributing to the strategic and operational leadership relative to the direction, planning, execution, and interpretation of clinical programs and the data collection activities. Works with senior Clinical Operations management to establish and approve (with CRO, Program Executive or Clinical Managers) scientific methods for design and implementation of clinical protocols, data collection systems and final reports. May also have responsibility for partnered programs in the areas of training, labeling, package design & pulmonary drug development. Monitors adherence to protocols. Interacts with various inside/outside groups to facilitate clinical programs. May select, develop, and evaluate personnel to ensure the efficient operation of the function. This job contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs. Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgments within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. Ensures budgets, schedules and performance requirements are met. Contributes to the development, management, and execution of the Clinical Development Plan (CDP) which includes timelines, budget, and resource requirements. Contributes to the development and implementation of the clinical program strategy and manages those systems and programs in order to meet Company goals and objectives. Provides strategic input into the CDP. Aides in the management of program advisory committees and/or expert consultants. Identifies program/resource gaps and proposes solutions. Provides weekly enrollment and program updates to senior manager. Ensures that Clinical Operations department functions effectively internally. Proposes innovative ideas to help resolve challenges faced by the project team. Remains current with medical developments and publications on similar and competitor products. Applies this knowledge to current programs. Manages internal staffing and performance management, including hiring, training, coaching and performance reviews. Mentors and develops clinical operations staff. A Bachelors/Masters degree in a scientific discipline is required. Equivalent experience may be accepted. A minimum of 10 years Pharmaceutical development experience with at least 4 years managing CROs is required. A minimum of 8 years previous management experience is may be required. Must have demonstrated ability to solve problems with innovative solutions along with strong organizational skills. Excellent written and verbal communication skills are required. Experience and understanding of ICH, and GCP is required. Knowledge of GMP and GLP is preferred. Must be a demonstrated self-starter and team player with strong interpersonal skills. Must possess excellent project management skills. Must have strong computer skills with a proficiency in Microsoft Project, Word, Excel, Visio, and PowerPoint. We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.
Nektar Therapeutics San Francisco, CA, USA
Mar 24, 2020
Full time
Position Overview Point of contact and functional lead for all operational activities relating to central vendor and sample management in order to delivery quality samples used in evaluating the drug efficacy. This role is an integral part of the study team during study startup, live phase and closeout. Ensures compliance with regulatory agency documentation and reporting requirements. Develops procedures and plans. May participate in vendor negotiations, product and software evaluations, implementations and management. May support both clinical and discovery samples. This job contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs. Works on issues of diverse scope where analysis of situation or data requires evaluation of a variety of factors, including an understanding of current business trends. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Acts as advisor to subordinates(s) to meet schedules and/or resolve technical problems. Develops and administers schedules, performance requirements; may have budget responsibilities. Works with Clinical Business Outsourcing in order to execute central lab contracts. Reviews and finalizes the central lab SOW and ensures all stakeholders are involved for the review. Identifies stakeholders for questions impacting clinical samples and escalate issues to ensure a timely resolutions. Addresses questions from the CRO or clinical site on sample collections. May assist in vendor selection. May assist in helping to manage testing vendors. Coordinates with business partners and stakeholders in determining samples flow. Mentors junior team members. Maintains professional demeanor when interacting with internal and external business partners. Conducts clinical laboratory trainings to CRAs or clinical sites. Ensures completion and accuracy of the Clinical Sample Management Plan. Utilizes tracking systems in order to report progress, address issues and resolutions. Oversees studies of moderate to high complexity. Leads meetings which ensures needs of the clinical samples are correct. Identifies resources to help conduct the study within Biosample Management. Possesses solid communications skills in order to efficiently and succinctly update the stakeholders on progress, questions and issues. Identifies, escalates and resolves complex issues. Works effectively in a dynamic operational environment with cross functional stakeholders. Other duties as assigned. Bachelor's or equivalent experience required; an advanced degree a plus. 8+ years of related experience with at least 2 years managing CROs daily management of a central laboratory required. Previous clinical biosample management experience is required, preferably in oncology. A minimum of 5 years of supervisory or management experience is preferred. Previous demonstration of developing and leading a biosample team required. Experience and understanding of ICH and GXP is required. Familiar with processes and restrictions of central vendors. Demonstrated ability to solve problems. Strong written and verbal communication skills are required. Must be a self-starter and team player with strong interpersonal skills. Must possess effective project management skills. We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.
Nektar Therapeutics San Francisco, CA, USA
Mar 24, 2020
Full time
Position Overview The Research Associate I will perform research and/or development in collaboration with others for projects. Exercises technical discretion in the execution of experiments that contribute to project strategies. Maintains familiarity with current scientific literature. Contributes to project process within a scientific discipline. Maintains professional expertise through familiarity with scientific literature. May participate in scientific conferences and contribute to scientific journals. Works on problems of moderate scope in which analysis of situation or data requires a review of identifiable factors. Exercises judgment within defined procedures and practices to determine appropriate action. Under direct supervision, executes on assigned tasks following appropriate laboratory/technical procedures. Makes detailed observations and analyzes data to provide some interpretation of results. Assists with the investigation, creation and development of methods, experiments and/or technologies for project advancement. Assists with the preparation of technical reports, summaries, protocols, and/or quantitative analyses. Uses professional concepts in accordance with company objectives to help solve routine technical problems. Maintains accurate and well-organized laboratory records, worksheets and notebooks. Maintains current training requirements. Maintains compliance to company Environmental Health and Safety policies, procedures and practices. A minimum of a Bachelors degree in a scientific discipline is required. Equivalent experience may be accepted. A minimum of 1 year work experience in a research and/or development environment is preferred. Previous hands-on practical laboratory experience is required. Must have a demonstrated working knowledge of scientific principles. Must be able to demonstrate basic decision-making skills. Must possess good oral and written communication skills. Must be able to demonstrate sound judgment. Must have demonstrated problem solving abilities. Strong organizational skills are required. Good computer skills are required. Working knowledge of MS word, Excel, Power point is a plus. Experience working in an FDA regulated environment is highly desired. Must be willing to work as part of a team and demonstrate good interpersonal skills. We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.
Nektar Therapeutics San Francisco, CA, USA
Mar 24, 2020
Full time
Position Overview This is a key position in the application implementation groups of the Nektar IT organization. This position will be responsible for the management of the selection, implementation, and ongoing maintenance of families of interrelated applications and systems supporting Nektar's various departments (Research, Drug Development, PDM, Finance, HR, Quality, Supply Chain, etc.). This position will also serve as an IT leader in collaborating with business partners to define the immediate, intermediate and long term solutions to the business's needs, as defined by the mutually determined business requirements. This position will manage multiple projects and programs and will collaborate closely with various business departments, cross-functional teams and our SaaS vendors. Finally this position will provide leadership in system delivery/implementation, regulatory compliance (SOX, GxP, etc.) within Nektar's SLC framework, tools and procedures. This position contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs. Works on significant and unique issues where analysis of situations or data requires an evaluation of intangibles. Exercises independent judgment in methods, techniques and evaluation criteria for obtaining results. Creates formal networks involving coordination among groups. Develops project plans, organizes and leads project teams, monitors progress and drives the delivery with focus on adhering to schedule. Facilitate sessions for use-cases, requirements gathering and configuration workshops, as necessary. Develops or reviews the necessary documentations (e.g. CapEx, Statement of Work, Service Level Agreement, Stakeholder Requirements, Functional Requirements, detailed schedule and budget and necessary SOP's). Leads and monitors the planning, deployment or required upgrades of Nektar systems, in support of Nektar's stated business objectives. Drives and coordinates system related Change Requests, Deviations / CAPA's and audits in accordance to governing SOX and GxP procedures. May participate in product evaluations (RFP/RFI), vendor selection, negotiates price and support options, and fosters vendor partnerships. Responsible for maintaining the validated and compliant state of all applications to ensure compliance to regulatory standards. Coordinates the implementation of enhancements/upgrades and provides backup for other IT SME ' s as required. Responds to critical issues during off hours when necessary. Work closely with the IT platform leads to apply standards and evolve process to ensure solutions abide by best practices and industry standards. Other duties as assigned. Creates formal networks involving coordination among groups. A minimum of a Bachelors' degree in Computer Science, Information Technology, or related discipline. is required. An advanced degree is highly preferred. Equivalent experience may be accepted. Certification in Project Management is preferred. A minimum of 12 years of relevant experience is required, which includes a minimum of 6 years of project management experience. Strong knowledge of procedures/ best practices related to FDA Regulations, SOX, EU GMP Annex 11, 21 CFR Part 11, Computer System Validation, GAMP 5, cGxP (cGCP, cGLP, cGMP) practices required. Familiar with system lifecycle (SLC) experience in a regulated environment. Familiar with Operating Systems, Infrastructure, VMWare Virtualization, and cloud-hosted technologies. Ability to articulate technical problems and business value to a wide business audience. Ability to troubleshoot issues and work independently with minimal supervision. Must be able to demonstrate strong analytical and problem-solving capabilities. Detail oriented and a hands-on PM, driving successful delivery of projects ensuring positive customer satisfaction. Excellent oral and written communication skills are required. Must possess and demonstrate strong leadership, influencing and organizational skills. Self-motivated with high degree of initiative and excellent follow-up skills. We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.
Nektar Therapeutics San Francisco, CA, USA
Mar 24, 2020
Full time
Position Overview The Research Associate I will perform research and/or development in collaboration with others for projects. Exercises technical discretion in the execution of experiments that contribute to project strategies. Maintains familiarity with current scientific literature. Contributes to project process within a scientific discipline. Maintains professional expertise through familiarity with scientific literature. May participate in scientific conferences and contribute to scientific journals. Works on problems of moderate scope in which analysis of situation or data requires a review of identifiable factors. Exercises judgment within defined procedures and practices to determine appropriate action. Under direct supervision, executes on assigned tasks following appropriate laboratory/technical procedures. Makes detailed observations and analyzes data to provide some interpretation of results. Assists with the investigation, creation and development of methods, experiments and/or technologies for project advancement. Assists with the preparation of technical reports, summaries, protocols, and/or quantitative analyses. Uses professional concepts in accordance with company objectives to help solve routine technical problems. Maintains accurate and well-organized laboratory records, worksheets and notebooks. Maintains current training requirements. Maintains compliance to company Environmental Health and Safety policies, procedures and practices. A minimum of a Bachelors degree in a scientific discipline is required. Equivalent experience may be accepted. A minimum of 1 year work experience in a research and/or development environment is preferred. Previous hands-on practical laboratory experience is required. Must have a demonstrated working knowledge of scientific principles. Must be able to demonstrate basic decision-making skills. Must possess good oral and written communication skills. Must be able to demonstrate sound judgment. Must have demonstrated problem solving abilities. Strong organizational skills are required. Good computer skills are required. Working knowledge of MS word, Excel, Power point is a plus. Experience working in an FDA regulated environment is highly desired. Must be willing to work as part of a team and demonstrate good interpersonal skills. We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.
Nektar Therapeutics San Francisco, CA, USA
Mar 23, 2020
Full time
Sr. Director, Clinical Development (MD) Location San Francisco Requisition Number 3 Apply Now Position Overview Oversees the direction, planning, execution, and interpretation of clinical trials/research and the data collection activities. Establishes and approves scientific methods for design and implementation of clinical protocols, data collection systems and fi esponsibilities: Responsible for the development and management of Clinical Development Plans (CDP) which includes timelines, budget and resource requirements. Develops and implements clinical program strategy and directs those systems and programs in order to meet Company goals and objectives. May create and chair the Medical Advisory Board for proprietary products. Participates in corporate development of methods, techniques and evaluation criteria for projects, programs and people. Directs the design of pivotal clinical studies for product and registration. Identifies and develops collaborations with external investigators and opinion leaders. Responsible for working closely with groups such as, Clinical Research, Data Management ,Regulatory Affairs, Clinical Operations, Marketing and Business Development. Acts as a clinical opinion leader working with physicians at a peer level. Directs and coordinates efforts to address medical and scientific issues. Works closely with Data Management and Biostatics to provide clinical analysis and promulgates scientific and clinical support for expansion of market share of Company products. Provides support to the business in the review of promotional materials and the training of product representatives. Performs medical monitoring. Supports the development of publications arising from studies and other relevant initiatives. Acts as a mentor to junior staff. Remains current with medical developments and publications on similar and competitor products. Applies this knowledge to current programs. May have responsibility for internal staffing and performance management, including hiring, training, coaching and performance reviews. Requirements: A minimum of a Bachelors degree in a scientific discipline is required. An MD degree is also required. A minimum of 7 years relevant clinical science/medical affairs experience is required. Must be able to demonstrate extensive experience in the design of clinical studies. A minimum of 5 years previous management experience may be required. Must have a demonstrated ability to solve problems with innovative solutions along with strong organizational skills. Excellent written and verbal communication skills are required. Previous experience working with senior management is required. Experience in conducting formal presentations to Sr. Management and key opinion leaders in required. Must have knowledge of effective competitive strategies as well as an in-depth understanding of clinical product development in the pharmaceutical industry. Strong analytical skills, especially with regard to understanding and interpreting scientific research and literature are essential. Experience and understanding of ICH, and GCP is required. Knowledge of GMP and GLP is preferred. Must be a demonstrated self-starter and team player with strong interpersonal skills. Must possess excellent project management skills. Must have strong computer skills with a proficiency in Microsoft Project, Word, Excel, Visio, and PowerPoint. Must be willing to travel. We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.