The Vice President, Clinical Development will play a key role in helping to set policy in a variety of organizational areas as the Company continues to evolve.
The Vice President, Clinical Development will oversee the clinical trials, clinical research and data collection activities for the Clinical Research function at a corporate level. S/he will have responsibility for developing the infrastructure to support advanced clinical trials / research / data collective activities and will set strategy for the function and processes, leading interactions with parties including, but not limited to, the U.S. Food and Drug Administration, Physicians, clinical sites and investigators. This position will contribute to and support the Company's research and development efforts to create high value therapeutics to address unmet medical needs.
- Lead and manage the Company's Clinical Research function, allocating and directing internal resources and effectively utilizing outsourcing to achieve project and business goals in a timely manner.
- Build an integrated organization that takes full advantage of Nektar's technological expertise to create a more powerful and value added products portfolio.
- Will have an integral role as part of the leadership team setting strategy and direction for the development organization
- Identify educational needs, research opportunities and implement tactics to support clinical research / trial programs in coordination with required department heads.
- Oversee the design of pivotal clinical studies for product and registration.
- Identify, develop and drive collaborations with external investigators and opinion leaders.
- Work closely with groups such as Medical Affairs, Clinical Research, Regulatory Affairs, Clinical Operations, Marketing and Business Development.
- Serve as a clinical opinion leader working with physicians at a peer level; oversee and coordinate efforts to address medical and scientific issues.
- Develop and implement methods and procedures for monitoring clinical research projects and deliver scientific presentations to individuals and groups of strategic importance to the Company.
- Identify academic centers, investigators and physicians to initiate and / or participate in clinical trials and identify key areas of future research.
- Support Medical Affairs in the development of publications arising from studies and other relevant initiatives.
- Act as a mentor to junior staff.
M.D. degree with a minimum of 12+ years of hands on experience and a successful track record of leadership in the biotechnology / pharmaceutical industry or other relevant experience in a medical product industry. Well grounded in drug development with extraordinary leadership competencies and the strategic business perspective needed to bring products forward and to maximize their commercial value. Experience working in Oncology is required; interest and ability to also work in areas outside of Oncology as part of a broader leadership team going forward is strongly desired. Thorough understanding of regulatory processes and prior experience working in a regulatory environment. Experience in both small and large companies would be advantageous. Demonstrated ability to lead by example and model collaborative behavior by soliciting opinions, coupled with the ability to make key decisions and be effective in getting the team behind the decisions. Demonstrated ability to solve problems with innovative solutions along with strong organizational skills. Excellent written and verbal communication skills. Ability to interact and communicate openly and effectively with Senior Management, key opinion leaders, regulatory bodies and development team members. Ability to develop and implement solid and high-value publication strategies for new and existing products in the Company's portfolio and to identify and implement high value strategies for product life cycle development and expansion. Experience conducting formal presentations to Senior Management and key opinion leaders. 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. Demonstrated self-starter and team player with strong interpersonal skills. Successful track record of hiring, training, exceptional people and motivating teams to the highest level of performance is required. Adept, nimble, energetic and comfortable in a highly dynamic and collaborative environment. Capable of taking a hands-on approach and willing to "roll up one's sleeves."
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.