Vice President, Clinical Development
Our client is a precision oncology pharmaceutical company. They have asked us to assist them in their search for a Vice President, Clinical Development.
Major tasks and responsibilities include:
We seek candidates with the following qualifications:
- Provides strategic medical input into the development of the company’s key assets identifying relevant target patient populations.
- Leads Product Development Teams and contributes to the creation of a successful lifecycle management strategy.
- Collaborates with physicians, scientists, regulatory professionals, biostatisticians, regulatory, executive staff, and others as necessary to validate and design clinical development plans including individual clinical trial protocols.
- Collaborates with Clinical Operations to execute clinical trials from beginning to end, overseeing study conduct, and interpreting the study results consistent with objectives to define safety, efficacy, pharmacokinetic/pharmacodynamic, patient reported outcomes, and application of data to a targeted patient population.
- Acts as Medical Lead and oversees medical monitoring activities.
- Leads the Product Safety Sub-Team.
- Acts as primary medical contact for study physicians and sites engaging during study feasibility through close-out.
- Provides input into and reviews other relevant study documents.
- Acts as subject matter expert on clinical and medical strategic initiatives and provide internal training/ collaboration as needed.
- Interprets clinical study and safety data for relevant clinical and regulatory documents.
- Develops and maintains strong, collaborative relationships with key internal and external stakeholders.
- Collaborates with Principal Investigators in the evaluation and assessment of emerging clinical experiences, data centric publications, and communication of emerging clinical data.
- Networks extensively to develop long-term strategic partnerships with thought leaders both internally and externally, in support of the company’s vision.
- An MD or equivalent with board certification or board qualifications in medical or pediatric or radiation oncology is required.
- Must have 10+ years of relevant experience, including medical training and clinic experience.
- Requires a minimum of 3 years drug development experience in Pharma, Biotech or CRO in Oncology drug development supporting studies to develop new biological therapeutics.
- Clinical experience in the implementation and development of companion diagnostics is desired.
- Must have a strong working knowledge of the clinical drug development process. Requires a track record in the conduct/participation in clinical trials (investigator initiated, company sponsored or cooperative group trials) and their subsequent publications.
- Successful academic research publication history or history of medical practice is required.
- The demonstrated ability to function in a matrix organizational environment is required.
- Must have solid personal and professional relationships with key opinion leaders (KOLs) in the oncology therapeutic community. Must have strong credibility within the broader US/European medical community which includes the ability to reach out to key thought leaders in academia.
- US State Licensure to practice medicine is desirable.
- Must be able to travel as necessary (up to 20%).
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
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