Senior Vice President, Clinical Development
Our client is a biopharmaceutical company. They have asked us to assist them in a search for a Senior Vice President, Clinical Development.
Major tasks and responsibilities include:
We seek candidates with the following qualifications:
- Leads and provides oversight of clinical development program(s), targets product profiles, and protocol development across Phase I-III programs.
- Provides clinical trial oversight (including site selection and start-up, data integrity, vendor management, management of accrual goals) in conjunction with clinical operations and leads analysis of clinical trial data and coordination of presentations and publications.
- Establishes appropriately aggressive clinical development timelines, incorporating key decision points and Go/No Go criteria for the clinical development plan.
- Collaborates with translational biology groups to develop and operationalize translational assays for clinical trials.
- Manages the clinical pipeline.
- Leads diligence into new indications for established programs and new targets for future programs, including work with therapeutic area heads and external consultants.
- Informs executive team and program/portfolio manager on progress of clinical programs and provides support for external communication including BOD and investors.
- Contributes to the build-out of the clinical development group, including medical writing/biostats resources and medical/clinician scientist hires.
- Collaborates with the development of clinical SOPs and infrastructure for storage and management of clinical documents in conjunction with clinical operations.
- Develops and maintains relationships with program counterparts in, Research, Regulatory and Statistics.
- Acts as deputy for the Head of Clinical Development.
- An MD or MD/PhD is required.
- Must have a minimum of 10+ years of experience in the pharma/biotech industry.
- Experience in a small to mid-sized biotech company is preferred.
- Must have experience as a medical lead on multiple different clinical programs and as a medical monitor on multiple clinical trials, including both Phase 1/2 as well as Phase 3 trials.
- Development experience in oncology and/or inflammation/immunology indications is preferred.
- Requires an established record of providing medical leadership and oversight on multiple INDs/CTAs, including face-to-face meetings with FDA and EMA.
- Must have a demonstrated ability to drive strategic and tactical thinking across multiple pipeline programs, including CDP, TPP and protocol development.
- Strong interpersonal skills and a proven ability to work cross-functionally with regulatory, clinical operations, and preclinical teams is required.
- Requires strong communication skills, including a track record of publications, presentations, and key contributions to regulatory documents (e.g. briefing documents, IND, NDA).
- Must have a proven ability to establish extensive and productive KOL networks within disease areas and leverage those relationships to build successful clinical development programs.
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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