Vice President, Clinical Development
Our client is a clinical-stage biopharmaceutical company. They have asked us to assist them in their search for a Vice President, Clinical Development.
Major tasks and responsibilities will include:
We seek candidates with the following qualifications:
- Provides clinical development oversight for Discovery and Development programs, including strategy, planning, execution, and completion of clinical trials according to all applicable regulations and guidance.
- Collaborates with Clinical Operations to ensure all clinical study activities are completed in accordance with applicable regulations and guidance; ICH GCP, and the company’s standard operating procedures.
- Reviews and interprets data from all phases of development.
- Assists in generating study reports and publications.
- Manages, coordinates, and provides ongoing assessment, evaluation, and communication with other departments and external vendors in order to ensure study objectives and timelines are accomplished.
- Serves as study medical monitor, as needed.
- Identifies and manages of external collaborators and key opinion leaders.
- Represents the company in interactions with regulatory agencies.
- Supports the CMO with oversight and management of the department budget and financial planning.
- Provides management personnel with timely updates on progress and changes in scope, schedule, and resources as required.
- Develops and implements SOPs for clinical trials and related activities, as required.
- Ensures compliance with all applicable regulatory standards related to global clinical trials and interactions with physicians.
- Develops and maintains professional relationships with academic and community-based study sites.
- Interfaces with departments within and outside of R&D including Finance, Regulatory Affairs, Legal, and Medical Affairs.
- Mentors and manages matrix and direct reports.
- Medical degree is required.
- Must have a minimum of 10 years of pharmaceutical industry experience.
- Experience with clinical development in Neurology/Neuromuscular disorders is required.
- Formal neurology or neuroscience training is highly preferred.
- Requires a strong scientific background.
- Must have strong project planning, leadership, negotiation and presentation skills as well as an ability to contribute creative yet practical solutions to problems.
- Requires experience with all aspects of management of clinical trials from inception to completion across all phases of development.
- Must have significant experience in communicating/presenting key/complex information to department/functional lead(s)/senior management.
- Strong knowledge of FDA and ICH regulations is required.
- Requires thorough knowledge of clinical medicine, clinical pharmacology and associated disciplines.
- Expert knowledge of Good Clinical Practice (CGP) is 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.