Precision Point Staffing ™ · 2 hours ago
SVP/VP of Clinical Development
Precision Point Staffing is seeking a Vice President or Senior Vice President of Clinical Development who will provide strategic and operational leadership for the company’s clinical development programs. This role involves designing and executing clinical development strategies while collaborating with various departments to ensure high quality and efficient clinical development aligned with corporate objectives.
Responsibilities
Develop and own the clinical development strategy across one or more programs from IND enabling through Phase 1 to Phase 3 and registration
Provide clinical leadership for protocol design, endpoint selection, dose rationale and patient population strategy
Serve as a key clinical voice in portfolio and asset level decision making including target product profiles and development plans
Represent Clinical Development on the executive team and contribute to overall corporate strategy
Program Execution and Oversight
Oversee the clinical development plans and ensure timely and high quality execution of clinical trials
Partner closely with Clinical Operations to ensure studies are designed for feasibility and operational excellence
Review and interpret clinical data to guide program decisions and next phase planning
Ensure studies are conducted in compliance with regulatory requirements and Good Clinical Practice
Cross Functional Collaboration
Collaborate with Regulatory Affairs on regulatory strategy and interactions including meetings with FDA and global health authorities
Work with Translational Medicine and Biometrics to ensure robust integration of clinical and scientific insights
Qualification
Required
MD required
Minimum of 10 to 15 years of clinical development experience in biotech or pharmaceutical industry with emphasis on Ophthalmology and/or Neurology trials
Demonstrated experience leading clinical programs from early development Phase I through late stage trials and commercial launch
Strong understanding of regulatory requirements and clinical trial design
Proven ability to interpret complex clinical data and translate into strategic decisions
Experience presenting to executive leadership regulatory agencies and external stakeholders
Strong leadership communication and cross functional collaboration skills
Preferred
MD PhD strongly preferred
Board certification in a Opthalmology/Neurology area highly desirable
Company
Precision Point Staffing ™
Precision Point Staffing's team of expert recruiters has a deep understanding of the job market, industry trends, and the skills and experience that employers are looking for in candidates.