Job Summary:

Precision is seeking an experienced and passionate regulatory physician to join our team as Vice President, Clinical Development. The Vice President, Clinical Development will have a demonstrated background in Autoimmune. The ideal candidate will have a deep understanding of the US Food and Drug Administration framework, and innovative regulatory strategies to accelerate drug development.

The Vice President, Clinical Development will be responsible for driving product development across the Precision portfolio, including drugs, biologics, and cell and gene therapies for autoimmune conditions. The role will focus on regulatory strategy and clinical development, for early to late phase trials.

Main Duties and 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, 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.

Education and Experience:

Minimum Education and Experience:

• 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.

Knowledge, Skills, and Competencies:

• Preference will be given to candidates with recent previous health authority experience (current or ex-FDA medical reviewers, etc.) 
• 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

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