Nektar Therapeutics

Nektar Therapeutics San Francisco, CA, USA
Nov 09, 2019
Full time
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 final reports. May recruit clinical investigators and negotiates study design and costs. Responsible for directing human clinical trials, phases I 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. Consistently works on abstract problems across functional areas of clinical development and medical affairs. Identifies and evaluates fundamental issues, providing strategy and direction for major functional areas involved with clinical development of pharmaceutical/biotech products. Interacts internally and externally with executive level management requiring negotiation of extremely difficult matters to influence policymaking bodies. 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 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
Nov 09, 2019
Full time
Position Overview Nektar Therapeutics has an exciting opportunity for a Corporate Counsel to join our Legal team. Advises on general legal matters pertaining to the Company across all sites. Provides a variety of corporate governance and securities legal services to the company under the direction of the company's general counsel. Acts as advisor on issues involving the organization's legal and regulatory compliance, with a particular emphasis on SEC and governance matters. Demonstrates comfort with advising on a broad range of legal matters, including transactional matters in the life sciences (pharmaceutical, biotech, drug delivery, and medical devices) industry, including but not limited to, drafting and negotiating research and development agreements, clinical research agreements, license agreements, and manufacturing and supply agreements without significant supervision. Familiarity with intellectual property law and FDA and European regulatory matters. Successfully manages a variety of corporate governance and securities issues for the company, and exercises sound legal and practical judgment in advising in-house clients on a variety of legal issues. Coordinates as appropriate with management and in-house and outside counsel in the handling of securities issues SEC compliance, governance and other matters. Helps to establish effective and efficient processes for meeting legal, contractual and compliance requirements. Coordinates with the Intellectual Property department to ensure that negotiated documents are sufficiently protective of Company IP. Coordinates with the Finance department to ensure that negotiated documents meet Company's financial requirements. Coordinates with other departments within the Company (regulatory, manufacturing, quality, program management) to ensure that negotiated documents meet Company's requirements in these areas. Provides legal and business counsel to Company and subsidiary management teams on an as required basis. Works on and may lead other projects as assigned. May provide guidance to junior legal staff. A JD degree and license to practice in the state of California are required. An undergraduate degree in a scientific field is a plus. A minimum of 7 years of legal experience is required, with a substantial majority of that time spent at a major law firm. Demonstrated proficiency in successfully counseling clients on matters of increasing complexity, along with assuming roles of increasing responsibility over their legal career is essential. The successful candidate will provide management with sound and practical legal advice to a variety of business issues, often on an expedited basis. Substantial experience in filing A minimum of 4 years of experience of drafting and negotiating complex life sciences agreements without significant supervision, including clinical research agreements, supply and manufacturing contracts, research and development contracts, licensing contracts, collaboration and strategic alliance agreements are required. A strong understanding of and experience with issues surrounding the business needs of life sciences companies including regulatory requirements, intellectual property, partnering activities and joint development are required. Experience in working with management in developing and managing complex business relationships is required. Experience in working on complex business relationships and related transactions where critical thinking in terms of strategy, tactics and coordination is required. Excellent analytical and problem solving skills. Excellent communication skills both oral and written, including strong drafting and negotiation skills are required. Must demonstrate ability to work effectively individually as well as in teams. 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
Nov 09, 2019
Full time
Position Overview The Sr. Director, Clinical Development (MD) will oversee 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 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. Consistently works on abstract problems across functional areas of clinical development and medical affairs. Identifies and evaluates fundamental issues, providing strategy and direction for major functional areas involved with clinical development of pharmaceutical/biotech products. Interacts internally and externally with executive level management requiring negotiation of extremely difficult matters to influence policymaking bodies. 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 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
Nov 08, 2019
Full time
Position Overview Nektar has an exciting opportunity for a Director, Accounting to join the Finance & Accounting Team. Directs the activities of general accounting functions. Develops, implements, and maintains systems, procedures and policies, including all general accounting functions. Ensures the accurate compilation, analysis and reporting of accounting data. Acts as a liaison between the company, government, CPA and other auditors in providing the required information and ensuring that proper information is maintained for historical purposes. Supports the preparation of federal, state and local reports and tax returns. Creates and interprets reports and records for management. Supports management in the preparation of management reporting, financial analysis and financial statements. May select, develop, and evaluate personnel to ensure the efficient operation of the function. Participates with other senior managers to establish strategic plans and objectives. Makes final decisions on administrative or operational matters and ensures operations effective achievement of objectives. 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. Regularly interacts with executives and/or major customers. Interactions frequently involve special skills, such as negotiating with customers or management or attempting to influence senior level leaders regarding matters of significance to the organization. Directs and controls the activities of a broad functional area within the company. Has overall control of planning, staffing, budgeting, managing expense priorities, and recommending and implementing changes to methods. Responsible for developing and maintaining sound business accounting policies, practices and standards to meet regulatory and management requirements. Managing, planning, and forecasting GAAP management operating reporting. Directs the recording, consolidation, arrangement, reporting and preservation of all financial data. Provides accounting consultation, assistance and service to leadership and other internal customers. Directs the accounting, preparation, analysis and required filings of all relative financial statements and related data and exhibits. Directs the preparation, analysis and filing of financial statements and other reports for internal and external sources. Reviews, advises, counsels and participates actively concerning new systems developments and other systems related matters to ensure accuracy of all financial data. Provides advice, counsel and assistance concerning accounting policies and practices. Develops and maintains strong business relationships with decision makers of targeted accounts and government agencies. Plans, initiates, and conducts account negotiations. Maintains fiscal responsibility for operational budget. Responds to applicable inquiries from internal and external auditors and other regulatory agencies. Directs the preparation of special reports, analyses and financials as requested by management and external agencies. Oversees and ensures Company business is in accordance with all regulations and Company policy and procedures. May provide regular performance feedback, development and coaching to junior accounting staff. A minimum of a Bachelors degree in a Finance or Business discipline is required. A CPA, MBA or other advanced degree is preferred. Equivalent experience may be accepted. A minimum of 13 years previous accounting experience, preferably in the biotech or pharmaceutical industry is required. A minimum of 8 years experience at an auditing company is highly preferred. A minimum of 8 years experience at a publicly traded company is highly preferred. May require a minimum of 10 years previous management experience. A thorough understanding of accounting principles is essential. Must be able to demonstrate a thorough knowledge of GAAP. Must be able to demonstrate a high attention to detail with an ability to independently prioritize and organize work assignments. Previous corporate accounting experience is required. Must possess excellent computer and analytical skills with proficiency in Excel. Good communication skills both oral and written are required. Previous experience with JDE ERP, COGNOS reporting, and Adaytum software are highly desired. Must be able to review and understand significant agreements as they pertain to the accounting group. 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
Nov 03, 2019
Full time
Position Overview Responsible for performing maintenance, testing, troubleshooting, calibration and repair on a variety of circuits, components, analytical equipment and instrumentation for laboratory and manufacturing equipment. Specifies and requests purchase of components. Analyzes results and may develop test specifications and electrical schematics. Maintains all logs and required documentation. Maintains spare parts inventory. May prepare technical reports with recommendations for solutions to technical problems. This job contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs. Coordinates scheduling and customer interaction for on-site calibration vendors to ensure timely completion and quality of work for equipment/instruments. Minimizes downtime for customers and maximizes calibration vendor's time on-site. Ensures calibration certificates and related documents are turned in by the vendor in a timely manner. Ensures timely scheduling/processing of instruments that require shipment to off-site vendors for calibration/repair. Works on assignments that are complex in nature in which considerable judgment and initiative are required in resolving problems and making recommendations. Must have knowledge of, and be able to use, meters, device network communications, NFPA 70E, general electrical skills, various hand tools and electrically rated tools. Ensures good communication and act as liaison between staff and outside service providers. Reviews calibration certificates and related documentation to ensure accuracy and compliance with cGMP/ISO requirements. May determine methods and procedures on new assignments. Assists instrument owners in completing calibration requests for new equipment (work with users to determine appropriate ranges and accuracy) as well as the timely repair/replacement of faulty instruments. Provides customer support for documenting instrument adds, moves and/or changes. Assists in maintaining tracking systems for equipment and instruments to assure appropriate level of control. May provide some on-the-job training to junior calibration personnel. Requires a minimum of a High School diploma. Equivalent experience may be accepted. An Associates degree or a certificate in a relevant calibration field is preferred. Certified ASQ or ISA Calibration/Instrument Technician Level 1 is a plus. A minimum of 4 years industry experience is required. Experience working in the Pharmaceutical, Biotechnology or other regulated industry is a plus. Working knowledge of FDA and GMP requirements is desired. Experience in calibration and analytical instrumentation is preferred. Strong attention to detail regarding documentation is a must. Good communication skills both oral and written are a must. Must be able to follow Standard Operating Procedures. Good computer skills are required. PLC programming experience is a plus. Must have excellent customer service skills and an ability to work well with others. Excellent organizational skills are required. Must have an ability to multi-task. Employees must be able to lift or handle objects greater than 25 pounds to perform certain duties essential to the job function. Employees may be required to perform tasks essential to the job function in areas that require the use of hearing protection devices. 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 must be able to wear a respiratory protection (filtering facepiece, 1/2 face, full-face, or powered air purifying respirator, supplied air, or self contained breathing apparatus) for certain tasks essential to the job function. Employees must be able to gain access to elevated work surfaces via vertical ladders or stairs to perform tasks essential to the job function. Employees must be able to able to accurately detect color and have 20/20 vision (with/without corrective lenses). Employees must be able to wear harnesses and use powerlift equipment (forklift, scissor lift, JLG). 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
Nov 03, 2019
Full time
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 San Francisco, CA, USA
Nov 03, 2019
Full time
Position Overview The Associate Director, Process and Data Standards , is a member of the Clinical Data Management team within Data Science & Systems. The Associate Director, Process and Data Standards, will provide leadership and support for Nektar's data standards, including support to DSS staff with data activities including CAPA responses, process deviations, and both internal and external audit responses. Supports inspection readiness and regulatory inspections. Conducts internal reviews to ensure compliance with SOPs and other procedural documents. Oversees process and document development and control, as well as Training Administration. This job requires strong attention to detail, project management, technical skills and development of standard process documents and templates. 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 or data requires an in-depth evaluation of various factors. Implements strategic policies when selecting methods, techniques, and evaluation criteria for obtaining results. Establishes and assures adherence to budgets, schedule, work plans, and performance requirements. Committed to ensuring that Clinical Data Standards are consistently of high quality for all of Nektar's clinical trials. Stays informed regarding the latest regulatory issues and guidelines for Drug Development. Provides guidance, training, and resources for compliance with existing laws and regulations in order to meet or exceed customer requirements. Leads efforts to increase the commitment to quality in individuals and a culture of quality within the organization. Manages and grows the team as needed, monitors resources and budget; ensures adequate resourcing of organization, develops staff. Drives, develops, enhances and finalizes processes which drive continuous improvement and enhance operational excellence across Data Sciences. Interacts independently and negotiates process improvements/solutions with process owners, subject matter stakeholders, and functional area teams. Implements process standardization within CDM and across collaborators within DSS and supports process development and standardization within EDC Programming and other functions. Creates, supports and enhances infrastructure. Manages and tracks CDM initiatives and projects. Oversees creation of CDM SOPs, work instructions, and other business enabling documentation, and acts as the DSS SOP point of contact and oversight on Nektar's SOP Committee. Establishes quality standards and work processes. Functions as a controller of CDM process changes and functions as a SME/advisor on CDM processes as needed. Serves as a liaison between Corporate QA, Clinical QA, Data Systems and Technology, and other functional groups to facilitate the development and implementation of quality systems. Oversees vendor assessment, qualification and re-qualification of CDM vendors and GxP systems. Collaborates with management on rollout of CDM training, ensuring that CDM related system, and study level training requirements are clearly defined and documented. Responds to and collaborates with Regulatory Compliance on CAPAs that require changes to Data Science/clinical data related process modifications (e.g. GDPR). Represents CDM/DSS at professional Quality meetings and may present company initiatives at such events, collaborates with other pharma industry leaders in Quality on industry initiatives. May represent CDM /DSS at regulatory inspections. Develops, implements inspection readiness program for CDM/DSS. Other duties as assigned. A minimum of a Bachelor's degree in computer science or a science related discipline is required . An advanced degree is preferred. Equivalent experience may be accepted. A minimum 10 years' related pharmaceutical/CRO experience and 8+ years of management experience. Clinical Data Management knowledge and management background is preferred. Relevant work experience consists of working in a pharmaceutical operation, data management, quality control, and quality assurance or compliance environment. A demonstrated understanding of pharmaceutical regulatory requirements and impact on development of clinical trials is required. Must have a highly developed knowledge of worldwide GCP regulatory requirements, including general principles for software validation (e.g., CFR Part 11). Understands current global and regional trends in regulatory compliance and ability to assess the impact of these requirements to the business. Considers a number of factors in planning, anticipate work and prioritize work to meet tight timelines. Understands impact of decisions and actions on business and consults with appropriate colleagues and management. Demonstrated self-starter and team player with strong interpersonal and project management skills. Must be able to solve complex problems and use highly developed independent judgment relating to national and international regulations, guidelines, investigator interactions and timelines. Must think critically and creatively and be able to work independently to determine appropriate resources for resolution of complex problems. Is recognized as a knowledgeable resource within the CDM department and from other departments on a range of topics and someone whose opinion is sought as a quality and compliance resource. Builds positive support for position outside of formal meetings. Acts as a role model for change by demonstrating commitment. Mentors others in establishing good working relationships. Must have excellent verbal, written, interpersonal skills and ability to lead multifunctional teams manage staff and mentor junior staff is required. Must have strong computer skills with a proficiency in Microsoft Project, Excel, Word and PowerPoint. Experience delivering presentations before executive staff 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
Nov 03, 2019
Full time
Position Overview Directs the planning, implementation and overall direction of executing/achieving clinical trial data management activities including CRF/eCRF design, database development, validation programming, discrepancy management, and database release. Manages Contract Research Organizations (CROs) and service providers' activities in overseeing the data management process life cycle in coordination with internal Biostatistics, Clinical, and Regulatory teams to ensure the accurate, efficient and complete data collection for clinical trials. 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. Directs the development and maintenance of the components of the study Data Management Plan (DMP). The DMP includes Case Report Form (CRF), CRF completion guidelines, SAS annotated CRFs, data handling plan, data entry review guidelines, edit check specifications, data transfer specifications, and database audit plan. Works with clinical, biostatistics, and regulatory teams to design and develop study documents including Clinical Protocol, Case Report Forms (CRFs) and Statistical Analysis Plan (SAP). Directs the interaction with contract data management groups to ensure that data management tasks remain on target according to project timelines. Proactively organizes on-going data review throughout the conduct of the study to ensure timely and appropriate identification of errors and discrepancies by working with a contract data management group. Responsible for the correction of errors and discrepancies through the site query process, for documenting permanent data issues, routinely communicating issues with team members and the delivery of a quality locked database for analysis. Leads new data management initiatives such as establishing capacity for electronic data capture. Conducts CROs data management function inspections and audits. Contributes to the development and implementation of departmental policies, standards and process improvement initiatives. May mentor and develop junior clinical data management staff. A minimum of a Bachelor's degree in clinical, biological, mathematical sciences or related field, or nursing qualification is required. An advanced degree is preferred. Equivalent experience may be accepted. A minimum 10 years pharmaceutical development experience with at least 4 years managing CROs is required. Must be able to demonstrate extensive experience in the design of clinical studies. A minimum of 8 years previous management experience is preferred. Must have demonstrated problem solving abilities and strong organizational skills. Excellent written and verbal communication skills are required. Experience and understanding of ICH, and GCP is required. Must be a demonstrated self-starter and team player with strong interpersonal skills. Must possess excellent project management skills.. Advanced knowledge of Data Management processes and systems. Solid understanding of clinical drug development processes is preferred. Ability to develop data management processes and training is preferred. Previous people management experience is preferred. Effective problem solving skills. Must have strong computer skills with a proficiency in Microsoft Project, Word 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
Nov 03, 2019
Full time
Position Overview Responsible for activities related to contracts management and compliance for corporate development such as, negotiating, structuring, and/or administrating contractual documents that establish business relationships with vendors and customers. Serves as a liaison between groups such as, Corporate Development, Sales, Legal and technical departments regarding contractual information. Analyzes contracts to ensure compliance to company policy, government specifications and other requirements. Uses skills to contribute to development of company objectives and principles and to achieve goals in creative and effective ways. 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. Contacts pertain to significant matters often involving coordination among groups. Acts independently to determine methods and procedures on new or special assignments. Performs a combination of planning, developing and recommending best methods to achieve contract goals and objectives. Tracks contract performance and compliance.. Ensures adherence to established contracting policies and procedures. Monitors the progress of contracts and identifies and compiles reports on contractual performance, financials and compliance. Compiles contractual information for budget and financial information, complex cost reimbursements and billing. Identifies and disseminates information to critical personnel with regard to changes and updates relating to contracts. Interfaces with a variety of senior internal and external customers providing guidance and information on complex contractual matters to meet requirements for contracts. Maintains contract and customer databases and files. Identifies, designs and provides a variety of reports to senior management. Performs other contracts related activities and projects as identified. May supervise the activities of junior contracts staff. A minimum of a Bachelors degree in Business Administration or related discipline is required. Professional certification or advanced degree is a plus. Equivalent experience may be accepted. A minimum of 8 years of directly related experience is required. Previous supervisory experience is a plus. Previous experience working in the pharmaceutical, biotechnology or medical device industry is preferred. Previous experience with external relationship management is required. Requires knowledge of business and industrial practices including cost factors. Must be able to demonstrate a knowledge of contract requirements, analysis of contract performance, and special provisions. Must be able to analyze and understand contract terms and conditions. Must be able to work with a high attention to detail. Must have excellent oral and written communications skills. Strong computer skills, including knowledge of databases and spreadsheets, are required. Must be able to demonstrate strong interpersonal and customer service skills. Must be able to demonstrate time management, priority management, planning and coordination/multi tasking skills. Must demonstrate an ability to build relationships and work as a team player. 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
Nov 03, 2019
Full time
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 Responsibilities: 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.
Nektar Therapeutics San Francisco, CA, USA
Nov 03, 2019
Full time
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 final reports. May recruit clinical investigators and negotiates study design and costs. Responsible for directing human clinical trials, phases I 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. Consistently works on abstract problems across functional areas of clinical development and medical affairs. Identifies and evaluates fundamental issues, providing strategy and direction for major functional areas involved with clinical development of pharmaceutical/biotech products. Interacts internally and externally with executive level management requiring negotiation of extremely difficult matters to influence policymaking bodies. 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 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 Huntsville, AL, USA
Nov 02, 2019
Full time
Position Overview Supports the design, development and transfer of manufacturing technology into clinical and commercial operations. Position Overview Provides expertise in process development and engineering including design, characterization, scale-up, optimization, technology transfer and validation. Introduces new products and technology from the laboratory to manufacturing. Assists manufacturing operations in problem solving to achieve cost effectiveness and improved product quality. Establishes product and process requirements for new process equipment. Interfaces with various departments to ensure processes and designs are compatible for new product requirements and to establish future manufacturing technology. Provides support for GMP manufacturing activities for Biologics clinical programs at Contract Manufacturing sites (CMOs). This job contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs. Description Works on problems of diverse scope where analysis of situations or data requires evaluation of variable factors. Demonstrates sound judgment in selecting methods and techniques for obtaining solutions; may select methods, techniques and evaluation criteria for obtaining results. Networks with senior internal and external contacts in own area of expertise. Uses skills as a seasoned, experienced professional with a full understanding of industry practices and company policies and procedures. Resolves a wide range of issues in imaginative as well as practical ways. Works cross functionally with contract manufacturers and consultants. May require travel to CMOs, both domestic and international, up to 25%. Identifies the majority of required studies and provides moderate to complex analysis. Resolves moderate to complex issues with studies. Prepares detailed reports, protocols and department instructional SOP's. Completes moderate investigations and issues findings and resolves moderate issues. Contributes and applies industry work practices and standards to efforts. Contributes to regulatory filings and reviews. Designs DOE for processes and analyzes complex data. Manages studies. Maintains equipment and interacts with designers to improve equipment or partners to design new equipment. May develop process development plans for projects. May lead specific projects with management input. A minimum of a Bachelor's degree in an engineering discipline is required. Equivalent experience may be accepted. A minimum of 7 years industry work experience in Biopharma is required. Must have 4 years experience in a cGMP biologics manufacturing or other regulated environment. Pharmaceutical process or Biologics process development experience is a must. Must possess sound technical judgment and use structured decision-making techniques. Experience with PEGylated proteins or other polymer conjugated proteins is a plus. Must demonstrate the ability to think critically and analytically. Excellent oral and written communication skills are a must. Excellent computer skills are required. Must have an ability to provide technical engineering support in a collaborative, team-oriented project environment. Experience with process characterization including DOE and statistical analysis is a plus. Good documentation and record keeping skills and attention to detail are essential. Employees must be able to lift or handle objects greater than 25 pounds to perform certain duties essential to the job function. 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 must have 20/20 vision (with/without corrective lenses). 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. Huntsville, AL only: Employee must be able to pass drug screening for employment consideration. 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
Nov 01, 2019
Full time
Position Overview Nektar Therapeutics has an exciting opportunity for an Executive Assistant to support the Sr. VP, Strategy & Corporate Affairs. Provides executive and investor relations administrative support to Sr. VP of Strategy & Corporate Affairs as well as occasionally investor relations and marketing team members. Requires in-depth knowledge of company operations, policies, and procedures. Handles details of a highly confidential and time-critical nature. Collects and prepares information for use in discussions/meetings (with executive committee). Prepares external and internal presentation materials for investors, media and board of director meetings. Makes high level contacts of a sensitive nature inside and outside the company. Highly visible position externally and internally across the company. Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors. Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results. Networks with key contacts. Interacts with senior internal and external personnel. Recommends and implements ideas to improve efficiency and or cost savings. This is both an internal and external facing role where professionalism is required. Manages coordination and calendar scheduling of meetings, conference calls, off-site events, catering and travel arrangements. Prepares materials for board and investor relations meetings. Designs and prepares Power Point presentations. Prioritizes responsibilities while managing multiple projects. Collects, prepares and reconciles information for externally disseminated materials and communications. Fosters and maintains strong working relationships within all levels of the company, external investor contacts, outside vendors and contacts. Maintains high level of customer satisfaction. Maintains department records and creates databases. Distributes necessary documentation and company policy & procedures. Additional responsibilities will include but are not limited to: Manage IR calendar and coordinate conference and event logistics including event registration, travel and meeting space for over 22 meetings a year in three different channels (bank-sponsored conferences, financial results calls, medical meetings, ), Manage travel and hotel logistics for IR conferences and events and process appropriate external speaker logistics and consulting arrangements On-site meeting event duties from pre-event preparation, logistics and AV coordination and overseeing the registration desk Additional duties include: Schedule conference calls and book meetings with investors, analysts (in-person and by phone) Project manage employee newsletter, working cross-functionally with areas across the company to organize content, manage outside vendor Schedule IR webcast and other advisories (working with department members) A minimum of a High School diploma is required. An Associates 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 or comparable experience is required. Previous supervisory experience is a plus. Ability to work with discretion and confidentiality is required. Must demonstrate an ability to establish priorities and react quickly and professionally. Must have extensive experience working with senior executives. Must be flexible. Must be able to travel for certain events. Excellent problem solving skills are required. Excellent oral and written communication skills are required. Attention to detail and follow through in completing assignments/projects is a must. Must be confident and able to work effectively and collaboratively with executives and other executive assistants. Able to work autonomously and as part of a team, remain calm under pressure. Exercises exceptional judgment. Extremely organized - able to multi-task, work on multiple projects at the same time, excellent time management and prioritize while remaining deadline focused. Excellent communication skills - able to deal with people at all levels, good written communication and confident telephone manner. Thorough knowledge in the use of PC programs such as Word, PowerPoint, Excel and other applications is required. 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
Oct 28, 2019
Full time
Position Overview Sr. Manager, Clinical Data Management independently leads the data management components of a clinical trial ranging from small early phase to large global and late phase programs. The assigned clinical trial(s) may be high complexity or high risk. The Sr. Manager, Clinical Data Management is accountable 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. Duties include serving as the primary data management liaison with vendors and senior management. This position contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs. 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. Maintain effective communication with vendors and Nektar's internal project team through oral and written correspondence, project status and progress reports. Independently 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. Independently manage 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. Oversee and 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. Manage the clinical study budget, ensuring the project remains within scope and that out of scope activities are identified and handled appropriately. 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 10 years actively managing clinical research projects in collaboration with other functional areas with at least 4 years successfully managing 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
Oct 25, 2019
Full time
Position Overview Nektar Therapeutics has an exciting opportunity for a Manager, Accounting to join their Finance & Accounting Team. Position Summary: Manages the preparation and filing of quarterly SEC financial statements (Form 10-Q's and Form 10-K's). Ensures the accurate compilation, analysis and reporting of accounting data in accordance with GAAP, including researching accounting issues and writing technical accounting memos . Manages the activities of certain general accounting functions. Acts as a lead liaison between the company, government, CPA and other auditors in providing the required information and ensuring that proper information is maintained for historical purposes. Creates and interprets reports and records for management. Supports management in the preparation of management reporting and financial analysis. Develops, implements, and maintains internal control systems, procedures and policies. May support the preparation of federal, state and local reports and tax returns. May select, develop, and evaluate personnel to ensure the efficient operation of the function. Responsibilities: Manages the preparation, review and filing of quarterly SEC financial statements (Form 10-Q's and Form 10-K's) and related XBRL files in accordance with GAAP and SEC disclosure requirements. Ensures the accuracy of financial and management reporting by independently completing trend analyses and reconciliation of balance sheet balances with transaction ledgers. Responsible for preparation and review of general journal entries and analyses for certain financial statement accounts. Reviews the accuracy of financial reports by analyzing variances between actuals and plan for significant and unusual activity. Assesses areas in which additional accruals may be necessary to cover the Company's business activities. Supports maintenance of the organization of accounts, departments and projects within the accounting systems to support all requested reporting. Develops and maintains reports to support financial and management reporting and other financial analysis. Leads coordination with the external auditors to explain the Company's financial reporting and accounting policies while satisfying the auditors' requests for analysis. Maintains thorough knowledge of new GAAP pronouncements to recommend and implement changes to policies, procedures and reporting in order to achieve compliance. Researches and prepares technical accounting memos and works with third-party valuation consultants as needed to support conclusions. Maintains thorough knowledge of SOX and related internal control expectations and responsible for maintaining related policies and procedures. Responsible for monitoring internal controls to ensure the accuracy of financial reporting and recommends corrective actions. Supports any computer system enhancements and implementations that might impact financial and management reporting. Performs other special projects related to analysis and activities requested by management, including supporting budgeting and forecasting activities. May provide regular performance feedback, development and coaching to junior accounting staff. Requirements: A minimum of a Bachelors degree in a Finance or Business discipline is required. A CPA, MBA or other advanced degree is preferred. Equivalent experience may be accepted. A minimum of 8 years previous accounting experience, preferably in the biotech or pharmaceutical industry is required. Previous corporate accounting experience is required and SEC reporting experience, including XBRL filings, is highly preferred. A minimum of 4 years experience in public accounting is highly preferred. A minimum of 3 years experience at a publicly traded company is highly preferred. Must be able to demonstrate a thorough knowledge of GAAP and SOX requirements. Must be able to demonstrate a high attention to detail with an ability to independently prioritize and organize work assignments. Must possess excellent computer and analytical skills with proficiency in Excel and Word. Good communication skills both oral and written are required. Previous experience with JDE ERP and Business Objects reporting software are highly desired. Must be able to review and understand significant agreements as they pertain to the accounting group. 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
Oct 21, 2019
Full time
Position Overview The Associate Director of Applications plans, conducts, and coordinates business programming applications activities in all areas across the enterprise. Summary This is a key position in the Nektar IT organization responsible for the evaluation, selection, implementation and support of those systems that enable Nektar's Sales, General and Administration (SG&A) groups to support the discovery, development, and delivery of therapies to our patients in need. As a part of this position, this individual will also be responsible for the planning and implementation of the additional systems to support commercialization. Finally, the right individual for this position will be a high energy, hands-on leader, assisting with the work load when needed, and passionate about implementing and supporting systems that make a difference for our customers Essential/Primary Duties, Functions and Responsibilities Collaborates with the SG&A business leaders to evaluate, select, implement and maintain those systems identified by the business groups as critical to their success. Leads RFP process for selection of systems and/or vendors used to support G&A solutions. Design and architect overall information management landscape and data flows related to SG&A systems. Works on issues where analysis of situations or data requires an in-depth knowledge of organizational objectives as well as an understanding of the business. Stays abreast of current software standards, and emerging technologies. Establishes and assures adherence to budgets, schedules, work plans and performance requirements. Leads the implementation and on-going support of business initiatives working with the appropriate internal and/or external resources to ensure on-going supportability. Develop project plans, organizes and leads project teams, monitors progress, and evaluates effectiveness of projects. Maintains on-going administration and roadmap of applications. Responsible for coordination and standardization of processes across the company to best meet operational and business requirements, including generate, revise, and review SOPs. Ensures that all GxP related activities associated with technical support are in full compliance with the ongoing dynamics of regulatory requirements. May have management responsibilities of internal and contract staff. Requirements A minimum of a Bachelor's degree in a Computer Science, Information Systems or related discipline is required. A minimum of 10 years industry work experience is required. Experience working with G&A systems (HR, Finance, Legal) required Understanding of Pharmaceuticals Industry Commercial processes related to Sales, Marketing, Market Access, and Medical Affairs is desired Experience working with Veeva Commercial suite (CRM, Vault, MDM, Datawarehouse) is desired Experience working with data visualization tools (Tableau, Qlikview) is desired Experience working with master data management, datawarehouse, reporting, and aggregate spend solutions is desired Knowledge and experience with systems development lifecycle and working in GxP environment is highly desired. Experience managing internal and/or contract staff is desired 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
Oct 18, 2019
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. Consistently works with abstract ideas or situations across functional areas of the business. Through assessment of intangible variables, 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 critical matters. Influences policymaking. 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
Oct 16, 2019
Full time
Position Overview Participates in the execution of scientific research and/or product development activities. Applies scientific principles and concepts to potential inventions, products and problems. Plans and executes laboratory research/experimentation. Maintains broad knowledge of state-of-the-art principles and theories. Makes contributions to scientific literature, conferences and/or understanding of company processes. 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. Normally receives general instructions on routine work, detailed instructions on new assignments. Participates in the development of patent applications. Interfaces with various departments, customers and partners. Uses professional concepts and scientific knowledge to contribute to the development of company concepts and principles to achieve objectives in creative and effective ways. Defines problems, develops approaches and develops experiments with sound judgment and some supervision. Puts work practices in context with larger team. Writes reports and protocols. May act as a principal investigator in conducting own experiments. May assist with implementing organizational systems, identifying capital equipment, and projecting near-term resource requirements. May provide guidance to junior scientific staff, providing training as needed, and ensures adherence to company policies and quality requirements. A PhD 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. Post-doctoral work may serve as experience. Exceptional non-PhDs with demonstrated capabilities and/or significant experience may also be considered. Must be able to demonstrate hands-on technical proficiency, scientific creativity, collaboration with others and independent thought. Must be able to clearly communicate scientific information both written and oral with minimal assistance. Must be able to compose sound written work with minimal assistance. Must possess good oral and written communication skills. Must be able to demonstrate sound judgment. Must be able to demonstrate problem solving capabilities. 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 and knowledge of current GMPs as they apply to laboratory practices are highly desired. Must be willing to work as part of a team. Must be able to demonstrate good interpersonal skills. Employees may be required to perform tasks essential to the job function in areas that require the use of hearing protection devices. 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 must be able to wear a respiratory protection (filtering facepiece, 1/2 face, full-face, or powered air purifying respirator, supplied air, or self contained breathing apparatus) for certain tasks essential to the job function. 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. Employees must be able to maneuver themselves under 30 inch clearances. Employees must be able to able to accurately detect color and have 20/20 vision (with/without corrective lenses). 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.