Vice President, Clinical Research
Our client is a clinical stage biotechnology company. They have asked us to assist them in a search for a Vice President, Clinical Research.
Major tasks and responsibilities include:
We seek candidates with the following qualifications:
- Works closely with the Chief Medical Officer, clinical operations, and translational research to set and execute the clinical and scientific strategy for the organization’s pipeline of clinical programs.
- Develops the strategy for clinical trial management and identifies suitable clinical trial sites to develop effective working relationships with clinical investigators and thought leaders.
- Manages internal and external resources to ensure clinical research plans are executed on time and within budget.
- Oversees management of clinical trial research selection, process, and data management as well as summarizes data and insights from clinical trials, including investigator selection, data sciences, data management, vendor oversight, analysis of patient recruitment strategies, milestones, coordination of lab samples, data collection, and analysis.
- Accounts for medical monitoring activities for Phase I-IV studies through direct execution of activities or supervision of medical monitors dependent on current staffing.
- Monitors clinical trials for safety and efficacy, and works in conjunction with external and internal drug safety to ensure timely reporting of safety signals to regulatory bodies.
- Supports and reviews regulatory submissions and reviews all SAEs and safety data as well as ensures that sites and regulatory agencies are notified and all company and regulatory procedures are compliant.
- Develops and writes of clinical trial protocols, investigator brochures, and other documents required to conduct clinical trials.
- Assists with the generation, analysis, and presentation of clinical data, including manuscripts, abstracts, and oral presentations.
- Partners with marketing to ensure timely, accurate, and compliant preparation and review of promotional and educational material.
- Establishes and executes a strategic publication and presentation plan and works with internal colleagues to develop key messages on unmet needs, mechanism of action, target product profile, and other materials.
- Works regularly as the face of the organization with key opinion leaders and key stakeholders, federal regulatory agencies, and partner companies and collaborators.
- Manages CROs including identifying suitable partners, defining CRO responsibilities, communication plan, divisions of responsibility, milestones, contracts, reviewing monthly status reports, and maintaining interactive management to ensure project success.
- A Medical degree or equivalent in clinical specialty is required. Experience in gene therapy, ophthalmology, or rare/orphan diseases is preferred.
- Must have 10+ years of experience in the pharma or biotech industry.
- A demonstrated track record in a clinical research leadership role in the US, study program management and robust understanding of Phase I-IV development projects and regulatory space is required.
- Must have relevant network experience with industry KOLs and experts.
- Experience in building, leading, driving, and engaging a successful team is required.
- Must be able to drive execution, continuously improve core teams, and reallocate resources at pace to keep up with clinical trial milestones.
- Requires the ability to attract talent and shape a high performance, enable the success of the team, and develop a culture that fosters collaboration, open communication and excellence.
- Must be a forward-facing business unit leader who understands and fosters culture and a shared vision as well as establishes a high level of ethics for the Chief Medical Officer and for the team.
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