Medical Director, Medical Affairs

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Veristat

WebsiteLinkedInAll Job Openings

501 - 1000 employees

💊 Pharmaceuticals

🧬 Biotechnology

🤝 B2B

💰 Private equity on 2021-05

Pharmaceuticals • Biotechnology • B2B

Veristat is a clinical development services company that provides end-to-end, regulatory-focused support for biopharmaceutical and medical device sponsors. The firm offers full-service clinical trial planning and conduct, regulatory affairs and submission support (including NDA/MAA and interactions with agencies like PMDA), statistical and biometrics services, medical writing, pharmacovigilance, and project management for complex therapeutic areas such as oncology, rare diseases, neurology, biologics, and cell & gene therapies. Veristat operates as a B2B partner to biotech and pharmaceutical organizations to reduce development risk and accelerate regulatory approval.

📋 Description

• Support the Medical Affairs department leadership in the development and implementation of medical and operational strategies, policies, and procedures • Manage and participate in the medically related activities within the planning and execution of clinical trials • Assist in the study feasibility process and be actively involved in all activities related to patient safety and pharmacovigilance, medical monitoring, medical training, and business development • Provide day-to-day leadership and manage direct reports within the Medical Affairs Department • Accountable for multiple projects and clients, managing client relationships and business expectations, delivering results successfully • Maintain a proactive, positive, result-oriented work environment

🎯 Requirements

• Post-graduate degree in a medical or health related field required (MD, BOARD CERTIFICATION A PLUS) • 10 years of relevant medical work experience required; prior experience in the clinical research setting strongly preferred • 5 years of people management experience or 5 years of experience leading project teams required • Proficient with International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines and other applicable regulatory rules and guidelines as well as of medical terminology, clinical trials, and clinical research required • Demonstrated ability to thoughtfully solve problems, exercise sound judgment, lead by example, and influence without authority required • Demonstrated ability to think “big picture” and strategically leverage expertise, to serve as a consultant and business partner with internal and external customers required • Excellent written and oral communication skills including grammatical/technical writing skills, and familiarity with moderately complex study designs and regulatory requirements that apply to Phase I-IV clinical trials are required • Working knowledge of the relationship and regulatory obligation of the contract research organization (CRO) industry with pharmaceutical / biotech companies required • Demonstrated ability to lead by example and demonstrated skill for technical and supervisory leadership of staff required • Skilled in use of computer software, including Microsoft Word and Microsoft Excel, and ability to learn new applications required • Ability to build and maintain trust and confidence and communicate effectively with client, external vendors, and internal team members required • Ability to mentor and effectively delegate required.

🏖️ Benefits

• Flexible, inclusive culture — 70% remote workforce • 66% women-led teams