Vice President, Late-Stage Clinical Development – CNS
Our client is a late-stage clinical pharmaceutical company. They have asked us to assist them in a search for a Vice President, Clinical Development - CNS.
Major tasks and responsibilities include:
We seek candidates with the following qualifications:
- Provides leadership and guidance for all clinical development activities and operations to team members in CNS.
- Holds responsibility for the clinical and scientific development for the product.
- Leads internal and external study teams from protocol development through final publication.
- Establishes and maintains relationships with partners, internal and external stakeholders, and investigators to optimize performance on clinical trial activities.
- Works collaboratively with research and development teams to provide input into the design of clinical studies.
- Ensures the ethical and scientific integrity of plans, studies, and products.
- Holds responsibility for the clinical portion of regulatory documents.
- Manages pharmacovigilance for clinical projects including reviews and reports.
- Accounts for medical monitor activities during all phases.
- Remains up to date with current information on regulations, guidelines and practices, and ensures consistent best practice across all activities.
- A Medical Degree with significant hands-on late phase clinical drug development experience is required.
- 10+ years of pharmaceutical or biotech industry experience in clinical research is required, including previous experience supporting registration, market access, commercialization, and product maintenance in CNS.
- Must have a solid understanding of Good Clinical Practice, clinical trial design, and regulatory and clinical development processes.
- A thorough understanding and experience in Phase III program development, trial conduct, NDA/BLA submissions, and interacting with FDA and other relevant health authorities is required.
- Must have strong strategic leadership and communication skills, with the ability to facilitate discussions across groups with diverse technical expertise and varying opinions to drive decisions on complex issues.
- Proven success leading the creation of Clinical Trial Protocols (CTPs), Investigator’s Brochures, Clinical Study Reports (CSRs), and regulatory documents is required.
- Requires an in-depth understanding of FDA regulations, ICH/GCP guidelines and other local guidance, and regulation and codes of practices related to clinical research and medical affairs.
- Must be comfortable working in a fast-paced and evolving company environment.
- Must have experience leading, managing, coaching, and developing direct reports.
- Advanced skills with MS Office and Clinical Trial Management Systems are required.
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.
Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms
and Forbes' list of Top 200 Best Executive Recruiting Firms