Nektar Therapeutics

Nektar Therapeutics San Francisco, CA, USA
Jan 24, 2020
Full time
Position Overview The Director, Financial Planning & Analysis will oversee the preparation, review and approval of annual budget and long-term financial plans. Monitors status compared to budgets and forecasts by function, by program and for the company in total. Prepares financial analyses to enable Executive Committee review and discussion with the Board of Directors of recurring and non-recurring transactions. May supervise & direct the activities of the financial planning & analysis staff. 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 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. Budgeting, forecasting & financial analyses: Oversees compilation of detailed budget from budget owners, SVP review of functional budgets and EC review of consolidated budget. Ensure current and multi-year budget & forecast estimates are in line with program strategy timeline and scope and cost estimates are reasonable. Prepares financial analyses to enable Executive Committee (EC) and Board of Directors (BOD) review and evaluation of annual budgets and proposed transactions. Provides support to partnered and proprietary programs throughout the Company ensuring programs remain on plan from a financial perspective. Critically reviews partner and proprietary programs from an investment and ROI standpoint as part of the portfolio review process. Execution of responsibilities above require: Communication, coordination and input from executive level management, Program Management and business operations. Understanding and analysis of R&D program requirements, interdependencies and cash payment timing, as well as accounting treatment under GAAP. Financial Operations: Review purchase requisitions (PR's) to ensure activity is within budget and Program's operating plan and forecast and account and project coding is accurate. Team with other functional areas (Legal, Purchasing, proponents) to facilitate compliance with purchase approval policies through IT systems and manual processes. Review contractual agreements to ensure they are sound from a financial perspective, optimize the Company's return, and identify potential accounting ramifications. Review FTE and temporary resource requests and evaluate impact upon current and future year results of operations. Review and authorize operating cash transfers to subsidiaries. Supervise year-end cash management activities to meet target cash balance. Skills & Knowledge: Excellent project management, analytical, computer and communication (both oral and written) skills are essential. Requires in-depth knowledge of the functional area, business strategies, and the company's goals. Must be able to demonstrate a high attention to detail Independently prioritize and organize work/projects/programs. Strong data analysis, modeling and Excel skills are required Previous corporate budgeting and planning experience are required. Previous experience with JDE ERP, Business Intelligence reporting software, and Microsoft Access are highly desired. A thorough understanding of principles of corporate finance and planning is essential. Must have a proven track record of successfully interacting with both internal and external executive levels. Education & Job Experience: A minimum of a Bachelors degree in a Finance or Business discipline is required. An advanced degree, such as an MBA, is preferred or equivalent experience may be accepted. A minimum of 13+ years previous financial planning experience, preferably in the biotech or pharmaceutical industry is required. May require a minimum of 10+ years previous management experience. 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
Jan 23, 2020
Full time
Position Overview The Associate Director of Applications plans, conducts, and coordinates business programming applications activities in all areas across the enterprise. Summary The Associate Director of Data Management will play a defining role in improving Nektar's focus on data by designing and developing an enterprise data model, focused on understanding, capturing and communicating the value of our data laterally (across organizations), longitudinally (across time) and vertically (across multiple levels of management). One of the key success factors in this role will be developing an understanding of the value of our data as the within the context of Nektars' environment and using this understanding to appropriately focus development efforts, while coordinating Nektar's progress on other data management programs to result in an enterprise data management solution. Initially, this role will focus on Nektar's commercial data needs. General responsibilities will include: Ensuring marketing, sales management, and sales teams have the information they need to deliver Nektar's products to our patients, and that our patients are supported in accessing Nektar products with the correct reimbursements applied Promoting the discipline of a 'single source of truth' Working across the Marketing, Sales, and Compliance teams to promote concepts of data stewardship Working within IT to support information sharing and simplified access to commercial data Essential/Primary Duties, Functions and Responsibilities Managing the selection, implementation and operation of Nektar's commercial data warehouse Leading cross functional teams to understand data needs and map them to third party or internal data solutions Managing the acquisition of commercial data sources, including data aggregation, patient support (access and reimbursement), sales analytics and reporting Defining and delivering a sales analytics platform and supporting tools for deployment to our field sales force Partnering with the sales operations team to ensure that sales reps have the right data at the right time to effectively manage their territories Managing key vendor relationships as required including data aggregation, patient support services (e.g., access and reimbursement), commercial data warehouse, and analytics platform vendors Defining and directing ongoing data integration and cleansing processes Requirements: In depth understanding of the pharmacutical industry, especially in commercial data warehouse development supporting field sales, sales management, and marketing organizations. Knowledge of Master Data Management (MDM), data governance, and data quality business processes, solutions, and methodologies Experience with reporting and analytics platforms (e.g., Tableau, Spotify, Qlik) Innovative thinker, with the ability to apply and implement leading technologies to deliver exceptional solutions to complex data problems Ability to define and resolve business problems via manageable data-driven solutions Experience in managing cross-functional teams involving technologies provided or supported by outside third parties Good understanding of the data flows and data harmonization issues in commercial pharmaceutical operations 10+ years experience in data management, with progressive levels of management responsibilities Exceptional analytical skills Excellent verbal and written communication skills Ability to commmunicate complex concepts clearly and concisely Strengths in working across all levels of the organization 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
Jan 16, 2020
Full time
Position Overview The Sr. Scientist, Biologics will apply scientific principles and concepts to potential inventions, products and problems. Senior Scientist, Biologics Analytical Development, part of Nektar Biologics Process Sciences organization, is responsible for product characterization, analytical method development of therapeutic proteins and protein-conjugates for Nektar Biologic products in pre-clinical and clinical development stages. Conducts and collaborates with others on analytical issues relevant to long-term objectives and concerns. Develops testing methodologies to support process development of drug substance and drug product. Responsibilities: The successful candidate will be responsible for: Characterize proteins and protein polymer conjugates to elucidate structure/function relationship, and binding activities with their receptors Develop and qualify analytical methods to support early & late stage drug development activities Assist process development scientists to characterize and monitor in-process purification Summarize experimental data and write technical reports This position contributes to and supports the company's biologics process development and manufacturing to create high value therapeutics to address unmet medical needs. Additional responsibilities include: Use professional concepts and company's policies and procedures to solve a wide range of difficult problems in imaginative and practical ways Determine methods and procedures on new assignments and recommend new methods and procedures Provide guidance to other lower level personnel Communicate cross-functionally with groups such as research, process development, formulation development, manufacturing, QC group and CRO/CMO to ensure appropriate project support Maintain a current knowledge of latest technological/scientific trends Requirements: Requires a PhD in a scientific discipline and a minimum of 7+ years related experience, may include post-doctoral experience. Exceptional non-PhDs with demonstrated capabilities and/or significant experience may also be considered. Must have in-depth knowledge and hands-on experience in characterization for protein and protein-PEG conjugates, especially binding of protein therapeutics to receptors Must have experience in protein structure analysis, such as X-ray crystallography, and protein-protein, and protein-compound modeling Must have experience in biophysical characterization of proteins and protein-protein complexes, such as surface plasma resonance, isothermal titration calorimetry, circular dichroism, AUC and etc. Must be able to demonstrate potential for technical proficiency, scientific creativity, collaboration with others and independent thought Must be able to clearly communicate scientific information both written and oral, with good publication records Works on problems of moderate scope in which analysis of situation or data requires a review of identifiable factors Good computer skills are required. Working knowledge of MS word, Excel, Power point is a plus Must be willing to work as part of a team 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
Jan 16, 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. 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
Jan 12, 2020
Full time
Position Overview Nektar Therapeutics has an exciting opportunity for a motivated Sr. Executive Assistant who will provide administrative support to the Senior VP, Finance & Chief Accounting Officer. 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 organizational skills, project management skills and 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. Ensures that Executive's productivity is enhanced by managing calendars and schedules, including tracking and facilitating priority deliverables. Performs administrative tasks such as calendaring, including scheduling of appointments, meetings, and conference calls, prepares expense reports and time cards, arranges internal catering and offsite events, coordinates domestic & international travel, and manages document organization, including establishing and maintaining shared file systems and related scanning, filing, etc. Will be responsible for working on board presentations and distributing board materials. Creates and/or modifies presentations as needed. The Sr. Executive Assistant will lead the document management process associated with the internal and external quarterly and annual audits. Prior experience with managing and organizing a large volume of documents within a tight timeline is preferred. 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. Candidate should possess a strong work ethic and have a positive, can-do attitude. Must be collaborative and a strong team player. 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
Jan 11, 2020
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
Jan 10, 2020
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
Jan 10, 2020
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
Jan 10, 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. 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
Jan 04, 2020
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
Jan 03, 2020
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
Jan 03, 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
Jan 03, 2020
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
Jan 03, 2020
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
Jan 02, 2020
Full time
Position Overview We are seeking a highly motivated, Research Associate to join the Bioanalytical Development Department at Nektar Therapeutics. The successful candidate will be responsible for developing and performing Ligand Binding Assays (e.g. ELISAs, ECLAs) for pharmacokinetic (PK), toxicokinetic (TK) and anti-drug antibodies (ADAs) assessments to advance research, pre-clinical, and clinical stage programs. The successful candidate will also be responsible for performing routine tasks as directed to maintain the laboratory. Essential/Primary Duties, Functions and Responsibilities Analyze clinical samples in compliance with GCP/GLP regulations and Nektar's SOPs. With guidance, develop complex assays for measuring the PK/TK of Nektar's PEGylated-protein, drug candidates. Compile data and analyze results in terms of quality/validity. Document all activities in the electronic notebook and Laboratory Information Management System (LIMS). Perform routine equipment maintenance, calibrations, and verifications as per SOP. Collaborate with other bioanalytical team members to complete tasks and meet departmental goals. Collaborate with members of other departments to complete tasks when required. Prepare study reports and SOP revisions. Requirements A minimum of a Bachelor's degree in biology, biochemistry, or other related scientific discipline with 5+ years of work experience. Equivalent experience may be accepted. In depth technical knowledge to understand the caveats of Ligand Binding Assays and to recognize issues during development and sample analysis. Experience performing and developing Ligand Binding Assays for PK/TK. Experience working in a GCP/GLP environment is desirable. Ability to work on multiple task/projects at the same time. Ability to work in a fast-paced, goal-oriented environment. Effective time-management skills. Self-motivated to carry out both new and routine tasks. Detailed oriented and able to follow instructions. Must be willing to work as part of a team and demonstrate good interpersonal skills. Proficient working with Microsoft Word, Excel, and PowerPoint. Past experience with electronic notebook systems and or LIMS 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
Jan 02, 2020
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
Dec 29, 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.