Job description
COMPANY BACKGROUND
Precision for Medicine is the first biomarker-driven clinical research and development services organization supporting life sciences companies in the use of biomarkers essential to targeting patient treatments more precisely and effectively. Precision applies a transformational approach to clinical research that integrates clinical trial design and execution with deep scientific knowledge, laboratory expertise, data sciences and advanced manufacturing solutions. This convergence is driving faster clinical development and approval. Precision for Medicine is part of Precision Medicine Group, with 3,400 people in 40 locations globally, across North America, Europe and Asia-Pacific.
In 2020, Precision Medicine Group completed a major investment and recapitalization led by funds managed by Blackstone, with significant participation from Precision’s co-founders, Ethan Leder and Mark Clein, as well as current shareholders Berkshire Partners, TPG Growth, Oak HC/FT, and Vida Ventures. With this new round of investment, Precision has expanded its global footprint and technical capabilities to help accelerate the development, approval, and commercial reach of breakthrough treatments from life science innovators.
Given its strong financial position, world class investors and leadership teams, and novel approach to clinical research, Precision for Medicine is primed to continue its successful track record of delivering critical insights into patient biology from early development through approval, resulting in more predictable trial outcomes, accelerated clinical development, and new life-changing treatments for the patients around the globe.
POSITION OVERVIEW
Precision is seeking an experienced and passionate regulatory physician to join our team as Vice President, Clinical Development, Oncology. The ideal candidate will have a deep understanding of the US Food and Drug Administration Oncology framework, and innovative regulatory strategies to accelerate drug development.
The Vice President, Clinical Development, Oncology will be responsible for driving product development across the Precision portfolio, including drugs, biologics, and cell and gene therapies for oncology and rare disease. The role will focus on regulatory strategy and clinical development, for early to late phase trials.
KEY 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 oncology 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.
PROFESSIONAL EXPERIENCE AND QUALIFICATIONS
Minimum Required:
- Successful completion of MD, MBBS, or equivalent training plus completion of training including a fellowship (Hematology-Oncology preferred; board certification preferred, including European equivalents)
- Experience in direct interactions with US and/or EU Regulatory Authorities
Preferred:
- At least 10 years of demonstrated knowledge and experience in the clinical research industry with substantial experience including related disciplines (i.e. operations, medical monitoring, biostatistics, regulatory, preclinical, translational pharmacology, 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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Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
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