Vice President, Global Clinical Development
Our client is a commercial-stage biopharmaceutical company. They have asked us to assist them in their search for a Vice President, Global Clinical Development.
Major tasks and responsibilities will include:
We seek candidates with the following qualifications:
- Leads the involvement of trial design for Phases 1-3 of the research trials, targeting rare or ultra-rare diseases.
- Requires knowledge and oversight in the areas of Endocrinology/Bone & CNS/Neurology.
- Directly supervises and monitors trial conduct.
- Works closely with all functions of the organization and external partners to manage trial logistics.
- Aids in developing global regulatory plans and plays a key role in meetings with regulatory affairs.
- Identifies opportunities for external collaboration.
- Follows important developments and relevant trends in the scientific literature.
- Develops/maintains contact with external experts to support understanding of the candidate drug effects and to gain strategic insight of further developments for the study and overall program.
- Develops effective relationships with external providers.
- Provides clinical assessment of potential in-licensing assets.
- Identifies novel therapeutic opportunities, as well as critical study design and execution challenges.
- Reviews written materials and provides editorial comments for clinical study reports and manuscripts.
- Ensures consistent practices with the highest ethical standards in compliance with internal SOPs, local regulations and laws.
- Designs and develops clinical study protocols and associated clinical study documents.
- Monitors required documentation in compliance with clinical development plans, GCP, and good medical practice.
- Participates in the selection of clinical investigators.
- Provides guidance to investigators on a study.
- Provides medical guidance for contract research organizations and protocol trials.
- Offers medical and scientific input in review of clinical data, patient medical safety data, and laboratory values.
- Maintains an ongoing assessment of the safety profile, and efficacy data as appropriate.
- Provides medical surveillance on Serious Adverse Event (SAE) reporting, and follow-ups.
- Directs and oversees the overall strategy for clinical drug product development.
- Teams up with Regulatory personnel in IND, CTA, and NDA submission activities as well as submission of IND safety reports.
- Leads the clinical aspect of interactions with regulatory agencies worldwide.
- Participates in the planning, writing, and review of Clinical Study Reports, regulatory updates, and submissions.
- Assists with the due diligence of new scientific developments.
- Analyzes and interprets study data for abstracts or publications as required.
- Collaborates on overall company strategy and in licensing of new programs.
- Works with the financial group as needed to assist with the production of budgets and timelines for the clinical development team.
- Plans and leads clinical focus groups to create clinical trial and protocol designs.
- Ensures that operational activities are conducted in compliance with all pertinent regulatory or statutory requirements and in accordance with the scientific standards, ethical and professional values, management philosophy, and established priorities, policies, and practices of the company.
- Takes charge of the medical writing for the preparation of the clinical trial data summarization.
- Overlooks the development and execution of clinical research and development programs, including the leadership of the pivotal trials and filing activities.
- Serves as a key liaison between company and clinical investigators.
- Requires a medical degree or equivalent.
- Must have 5+ years of clinical and managerial drug development experience.
- Must have experience in clinical development.
- Requires excellent interpersonal and public speaking skills.
- Requires the ability to work in a matrix environment with cross-functional teams.
- Travel up to 20% of the time annually (domestic and international) 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.