Vice President, Clinical Development

🕒 April 1

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Logo of Precision Medicine Group

Precision Medicine Group

1001 - 5000 employees

Founded 2012

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

💰 $35.2M Venture Round on 2021-03

Biotechnology • Healthcare Insurance • Pharmaceuticals

Precision Medicine Group is a global team of experts that specializes in precision medicine, which combines advanced lab sciences, translational informatics, regulatory affairs, payer insights, and marketing communications. The company focuses on overcoming product development and commercialization challenges for pharmaceutical and life sciences clients. Their services include biomarker-driven research and development, as well as commercialization support for life science organizations from launch to product maturity. Precision Medicine Group operates through two main arms: Precision for Medicine and Precision AQ, specializing in clinical and commercial solutions respectively.

📋 Description

• 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.

🎯 Requirements

• 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.

🏖️ Benefits

• health insurance • retirement savings benefits • life insurance • disability benefits • parental leave • paid time off for sick leave and vacation

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