Vice President, Clinical Development
Our client is a clinical-stage biopharmaceutical company focused on innovative therapeutics to treat life-threatening diseases. 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 a strong, clear clinical voice for the company’s clinical programs in conjunction with the Clinical Operation and Regulatory heads.
- Provides leadership and mentorship to clinical development team members.
- Provides and recruits necessary specific therapeutic area expertise to enhance innovation and efficiency in the company’s drug development programs.
- Leads clinical efforts to secure regulatory approvals.
- Oversees and reviews clinical trial conduct and data acquisition, external clinical data collection and clinical competitive intelligence.
- Provides strategic perspective and guidance to Research on decisions that may have significant clinical components and implications.
- Collaborates closely with Research, Regulatory, Clinical Operations, CMC, and Medical Affairs to ensure tight strategic integration of product development plans and strategies.
- Holds responsibility for final review and sign off with respect to all controlled documents including protocols, IBs, and Clinical Study Reports.
- Maintains the highest quality clinical programs, following GCP and ICH guidelines.
- An Medical degree or MD/PhD with ten years of industry experience is required. Experience in a small to mid-sized biotech company is preferred.
- Infectious Diseases clinical development experience is preferred.
- Must have a proven track record of drug development experience. Experience in phase one through three is preferred.
- Must have outstanding communication and leadership skills accompanied by a readiness to "roll up the sleeves" to contribute to team efforts.
- The ability to develop creative approaches to processes, practices, services, business models, and strategy is required.
- Must be able to take personal accountability for outcomes and thrive on increasing levels of responsibility to move the business forward.
- Robust regulatory experience with Pre-INDs, INDs, CTAs, EOP 2 meetings and NDA/BLAs/MAA, both US and ex-US is required.
- Requires experience having built and managed high-performing teams and navigating significant accelerations and challenges in clinical 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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