Vice President, Clinical Development
Employment Type: Full-Time
Industry: Scientific Research
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VICE PRESIDENT, CLINICAL DEVELOPMENTPosition Summary:
This position will be responsible for leading the clinical development and clinical pharmacology groups and will be accountable for the clinical elements of development strategies and plans for development stage and marketed products from First in Human through lifecycle management. The position requires building, developing and mentoring a team that will provide hands-on clinical leadership of cross-functional clinical and/or project teams. The leader will partner with Research on early pipeline strategies and will work closely with Business Development to assess potential in-licensing product candidates. Individual in this role will manage a team of physicians and scientists at various levels responsible for clinical and clinical pharmacology studies and may include management of additional staff and functions closely allied to clinical science.
This position will provide strategic guidance to the teams during the design, execution, and reporting of clinical studies and may require some hands-on accountability for study oversight/management. The successful candidate will influence through the cross-functional team structures as well as through direct line management to guide clinical development strategy across programs. The leader may be a member of a cross-functional product development team.Position Responsibilities:
- Accountable for overseeing the development of the clinical program strategy, tactics and execution
- Actively manage, mentor and direct resourcing within the Clinical Development group
- Manage and direct the team that is responsible for the design and authorship of study protocols and interpretation of clinical study data
- Work closely with Clinical Operations colleagues on study implementation and oversight, which includes site and CRO selection and investigator meeting preparation
- In conjunction with the Clinical Operations, responsible for the on-time and within-budget execution of protocols
- In conjunction with Development colleagues, prepare strategy presentations, present and discuss data at relevant team, governance, external consultant, KOL, and regulatory meetings
- Author clinical sections of regulatory documents (IB, Annual Reports, IND sections, CSR)
- Participate in preparation for and conduct of meetings with Healthcare Authorities
- Educate team members and vendors on the molecule and disease area and participating in internal continuing education activities
- Represent the clinical function on the project team
- May have functional responsibility for other clinicians or clinical scientists assigned to the project and may supervise and develop other colleagues
- Organize and prepare for Advisory Board meetings
- Act as clinical representative for in-licensing activities such as due diligence reviews, reports, and development strategies.
- Member of the Development Leadership Team and be delegate for Head of Development when necessary
Fit with GBT culture:
- M.D. with board certification or eligibility preferred
- A proven leader with 10+ years of clinical development experience in the biotechnology or pharmaceutical industry, with management experience
- Experience leading cross-functional teams and managing physicians and scientist
- Experience and expertise in the design and conduct of First-In-Human studies through pivotal programs with a track record of innovative and expeditious program and study design to demonstrate proof-of-concept, characterize dose-response and design and execute pivotal studies
- Extensive experience leading the design, conduct, analysis, and reporting of clinical studies, including experience authoring and submitting relevant sections of regulatory submissions for INDs, CTAs and NDA/BLA/MAA and will have an established track record of publishing articles and abstracts in professional journals
- Demonstrated outstanding leadership of multiple development projects and teams
- Significant successful interactions with key opinion leaders and investigators
- An excellent scientific track record demonstrated by publication record in refereed journals
- Proven ability to effectively work in a cross-functional/matrix environment and successfully leverage internal and external partnerships
- Outstanding organizational and time management skills; proven abilities to manage multiple, often complex and sometimes competing, objectives, goals and other priorities to effective and efficient conclusion
- Strategic agility; in-depth knowledge and broad experience in the pharmaceutical or biotech industry and the ability to bring this to bear in accomplishing strategic goals and objectives
- Outstanding judgment and decision-making skills; past results are indicative of consistently sound and effective business decisions
- Strong interpersonal, influencing, presentation, and written and verbal communications skills; able to effectively address all levels within an organization
- Willingness and ability to travel
- Ability to build strong relationships with co-workers of various backgrounds and expertise
- Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor
- Values-based leadership consistent with GBT's Core Values
- Excitement about the vision and mission of GBT
NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.
Global Blood Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
Associated topics: design, engineering, manufacture, product, product manager, production, program manager, quality
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