Vice President, Drug Safety/Medical Affairs:
Attractive NYC area Biotech, Report to CMO
An innovative and attractive, publicly-traded Biotech is looking for a Vice President of Drug Safety/Medical Affairs. This position will report directly to the CMO and will manage a strong and established Drug Safety Group as well as a growing and unique Medical Affairs function. Our client is looking for a uniquely qualified candidate that has a strong academic/medical/research foundation along with strong leadership skills and the ability to navigate across a dynamic and ever-changing Biotech culture. This is a role that will require both hands-on medical expertise as well as the ability to lead direct reports and manage cross-functional relationships (executive and staff-level). In addition to Drug Safety and Medical Affairs leadership responsibilities, you will also have the opportunity to collaborate across cutting-edge Clinical Development planning and execution.
Attractive features about this position and company:
- Stability & Growth: Our client has an approved product as well as a multi-therapeutic pipeline across all stages of development. They are not a one-compound Biotech, which mitigates a great deal of the risk that is often associated with Biotech companies.
- Immediate opportunity to make an organizational impact: You won’t have to “wait your turn” as is often the case at larger/mid-size Pharmaceutical/Biotech companies. You will report directly to a very strong CMO that empowers their people. We have a 5+ year relationship with the CMO and have seen this first hand.
- Innovative Company: Work for a unique biotechnology company, which is focusing on innovative therapies that have the opportunity to shift the Biotech/Pharma paradigm.
- Unique Culture: Work in a very entrepreneurial, fast-paced environment, which will not only gain you valuable experience, but is also a tremendous opportunity for professional and personal growth and development.
- Unique Position: A unique position to leverage both Drug Safety and Medical Affairs experience. Our client will also consider a candidate with a strong Drug Safety background that has aspirations to grow their career within Medical Affairs.
Location: New York City/New Jersey area
- Overall leadership responsibility for the Drug Safety/Risk Management/PV department, both US and Global.
- In a hands-on capacity, lead strategy and tactical operations across Drug Safety disciplines to include direct reports as well as team and cross-functional leadership.
- Work closely with Clinical Development colleagues/peers in developing/designing NDA submission strategy and subsequent product launch(s).
- Oversight and leadership for the preparation of Drug Safety and Medical Affairs annual objectives/goals, annual budgets, and long-range plans.
- Development of Medical Affairs strategy and operations focused within Publications, Medical/Scientific Communications, KOL development/relationship building, Advocacy Groups, Policy, Market Access/Pricing and Commercial Strategy.
- Ensure accuracy of data for all medical publications, presentations, response letters, and all responses to medical inquiries in close partnership with the CMO.
- Extensive interaction and collaboration across the organization and with other executives.
- Medical Degree is required. US Board Certification is a plus.
- 5-10+ years of experience focused in Drug Safety/Risk Management/Pharmacovigilance and/or Medical Affairs, ideally to include global experience.
- Direct report/people management experience.
- A flexible and creative mind-set that thrives working in an ever-changing and dynamic environment.
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Thomas J. Fascia