Precision Medicine Group · 7 hours ago
Vice President, Clinical Development
United States
Full-time
Remote
Director/Executive
$255K/yr - $382K/yr
10+ years expPrecision Medicine Group is seeking an experienced and passionate regulatory physician to join their team as Vice President, Clinical Development. This role will focus on driving product development across the Precision portfolio, including drugs, biologics, and cell and gene therapies for autoimmune and oncology conditions, while providing strategic drug development consulting and regulatory strategy support.
BiotechnologyHealth Care
Responsibilities
Reports to Chief Medical Officer, and across Precision for Medicine, supporting medical strategy
Provides medical and strategic support for business development activities globally including client engagement, proposal support, client capabilities meetings, and professional meetings
Provides strategic drug development consulting to autoimmune, or oncology depending on specialty, and rare and orphan disease clients. The consulting will be provided in the context of an integrated strategy with medical, clinical, regulatory, biostatistical, translational and marketing insights
Create, review, or revise protocols, case report forms, training materials, project-specific tools, analysis plans, study designs, clinical trial reports, and investigational new drug applications
Review laboratory values, adverse events, coding dictionaries and data tables, listings and figures as needed
Participate and drive feasibility discussions relating to specific project proposals
Develop training modules and conducts training for project teams and colleagues as necessary
Ensure high quality, data driven deliverables that meet the highest standards of medical, ethical, and scientific integrity and conduct
Propose strategies to manage and accelerate timelines for drug development strategies
Ensures customer satisfaction by working closely with senior management, PFM operations, to provide optimum strategic consultancy to clients
Qualification
Required
Successful completion of MD, MBBS, or equivalent training plus completion of training including a fellowship (Endocrinology, Rheumatology, Hematology-Oncology or other related field, board certification preferred, including European equivalents)
Experience in direct interactions with US and/or EU Regulatory Authorities
At least 10 years of senior leadership experience in the clinical research industry with a demonstrated knowledge and substantial experience including related disciplines (i.e. operations, medical monitoring, biostatistics, regulatory, preclinical, translational pharmacology, etc.) Or equivalent combination of education, professional training and experience that provides the individual with the required knowledge, skills, and abilities to perform the job
Clinical experience with previous exposure to regulatory and statistical activities such as (co) authoring and reviewing of documents such as clinical trial protocols, statistical analysis plans, IND, NDA, PSUR, DSUR, IB, ICF, Breakthrough Designation, and regulatory briefing documents
Working knowledge of the safety reporting process globally
The ability to travel domestically and/or internationally for Client and/or Health Authority Meetings and Thought Leadership/Conference Attendance
Benefits
Discretionary annual bonus
Health insurance
Retirement savings benefits
Life insurance
Disability benefits
Parental leave
Paid time off for sick leave and vacation
Company
Precision Medicine Group
We founded Precision Medicine Group in 2012 because we believed there was a transformational opportunity to improve the process of bringing new drugs to market.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Mark Clein
Co-Founder & Chief Executive Officer
Matt DeZee
Chief Financial Officer
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