Vice President, Drug Safety/RM/PV: Newly Created Position, Build Function
Boston Biotech: RETAINED SEARCH
Our client is a fast-growing Biotech focused within innovative Oncology Drug Development. In this newly created role, you will report directly to the CMO and have the opportunity to truly build the entire Drug Safety function from scratch (structure/hiring, strategy, vendors, SOPs, systems, operations, etc.). While this is a development-stage Biotech, they are incredibly well-funded and continue to grow their pipeline both internally and externally and are very stable.
This is an excellent opportunity for a Drug Safety professional looking for the opportunity to build something from the ground floor without the red tape that exists in most mid-size to larger companies. You will have complete autonomy to build the group in your liking while also having the support of a well-funded company to resource the group effectively.
Cornerstone has a long-term relationship with this organization. They have always proven to offer very strong compensation and relocation packages to qualified candidates.
Location: Boston/Cambridge area. Our client can offer a competitive relocation package.
Scope of Responsibilities:
- Ownership/accountability for all Drug Safety, Pharmacovigilance and Risk Management activities across Clinical Development and future Commercialization.
- Build from scratch a dedicated team of Drug Safety/PV professionals to include Physicians, Operations, etc.
- Develop policies, SOPs, timelines, budgets, etc.
- Lead/implement signal detection and risk management activities.
- Lead/direct all safety related regulatory interactions, serving as the key communicator to external parties regarding safety issues for all clinical development programs and future commercial products.
- Monitor and assess all safety issues across all development programs ensuring that all safety related activities comply with applicable local standards and pharmacovigilance exchange agreements with partners.
- Ensure timely and accurate submission of all safety reports to regulatory authorities in compliance with safety reporting standards.
- Oversee the implementation and maintenance of global safety database and report generating systems to support timely safety reporting to FDA and global regulatory agencies.
- Represent the Company at medical/scientific meetings and congresses pertaining to areas related to Drug Safety.
- D. degree with ideally 7+ years of focused drug safety experience.
- Oncology experience is a plus, but not required.
- Direct report experience.
- Highly developed industry acumen with an ability to formulate complex strategies, operational plans and change strategies that address the interests and needs of the Company.
- Proven ability to investigate and resolve complex safety related issues, and make/evaluate proposals for appropriate corrective action.
- Strong understanding of global drug safety dynamics.
- Direct experience interacting with the FDA as well as ideally with global health agencies and authorities.
- Positive reputation with the FDA (and ideally other international regulatory bodies) as well as with peers, investigators, etc.
- Demonstrated ability to align people, policies, and processes to foster a collaborative environment and to sustain collaboration through the continual communication of group mission and team based outcomes.
Thomas Fascia, Partner
email@example.com - P 973-656-0220 x717
CORNERSTONE SEARCH GROUP – Life Sciences Executive Search
6 Campus Drive | Parsippany, NJ 07054 USA
CH: 41 61 508 7010