Head, Drug Safety/PV – Mid-Stage, Pre-IPO Oncology Biotech in Boston Area: RETAINED SEARCH
Cornerstone’s MD Practice has been retained on an exclusive basis by a well-funded and innovative pre-IPO Oncology Biotech with multiple clinical assets (in all Phases – I, II & III) in the Boston metro area that was founded by pharma industry veterans. We have a long-standing relationship with the Chief Development Officer (hiring manager) who is looking to hire her company’s first Head of Global Drug Safety & Pharmacovigilance (PV) at the SD/ED/VP level depending upon experience. This is a great opportunity to join a pre-IPO, Series B Biotech before they grow larger. You will receive a strong stock option package and can truly drive hands-on value through direct leadership of the Drug Safety/PV function including: strategy, operations, cross-functional leadership, executive-level collaboration, etc. In addition, this position will include Medical Monitoring and other Clinical Research-related activities, which is great experience to gain if you don’t have it already. Our client also respects talent and the realities of everyday life and allows their people the opportunity to work up to 2 days a week from home.
Location: Boston Metro Area, MA.
Attractive Features about this Company & Opportunity:
- Exciting Newly-Created Leadership Role: You will have the opportunity to create what and how the Drug Safety/PV footprint will look like within the organization, as well as setting the overall strategic vision for the department. Our client is hiring the person not just a resume. They are willing to hire at the Senior Director, Executive Director, or Vice President-level depending on the candidate’s experience.
- Financial Stability & Opportunity: Our client is very well-funded as compared to other peers. Furthermore, you will have the opportunity for a strong stock option package so that you can financially be rewarded for the value you bring.
- Great Time to Join: Now is a perfect time to join this company as they multiple assets in different stages of development, has raised significant Series B financing, and you can really help to shape the organization going forward.
- “Best of Both Worlds”: The company offers all the attractive features sought with a quickly growing entrepreneurial Biotech (small team comradery, fast-paced, high-impact, agility), while also offering a flat organization structure with minimal layers of management, “red tape,” internal politics and bureaucracy which fosters more communications and swifter decision making (i.e. emphasis on progress and moving things forward).
- Cutting-Edge Oncology Therapies / Novel Proprietary Technology: This company has been developing its own unique technology, opening a vast domain for discovering effective cancer treatments. This company has multiple clinical stage oncology assets in all phases (I-III) of clinical development.
- Excellent Hiring Manager: You will report directly to the Chief Development Officer (whom we know personally for many years) who is smart, personable, well-liked, and well-respected.
- Unique Culture & Forward Thinking Organization: a collegial, collaborative and enjoyable culture where people are highly engaged, smart, enthusiastic, and passionate about making a difference in the lives of cancer patients.
Role and Responsibilities:
- Lead the preparation of safety information for regulatory (including IND and NDA/BLA) submission documents.
- Oversee the development of the relevant medical sections of responses to safety-related health authority requests as well as clinical documents such as Investigator’s Brochures, clinical protocols, safety management plans, study reports, and integrated analyses.
- Lead the development of pharmacovigilance strategies for monitoring the safety profile of investigational products.
- Work collaboratively with clinical development and translational leaders including Biostatistics/Programming, Clinical Operations, and Regulatory Affairs.
- Build and manage a Drug Safety team as appropriate; identify systems and resource needs for a high-functioning medical safety evaluation process
- Mentoring junior team members, providing guidance and opportunity for their professional development.
- Responsible for the analysis of safety data, risk detection and benefit/risk management activities.
- Manage external vendors / CROs overseeing the collection of safety data.
- Lead aggregate safety data reviews and the preparation of the medical content, periodic reports (including PSURs, DSURs), and ad-hoc reports.
- Organize and conduct regular Safety Board meetings to review aggregate safety information and signal management.
- Oversee medical review of CSRs.
- Identify opportunities and manage continuous improvement initiatives as related to the medical assessment of pharmacovigilance data.
- Accountable for the strategic planning and execution (including study design, method selection, etc.) of Phase I through IV global clinical trials with a focus on the safety and clinical outcomes.
- Analyze and interpret data expertly with clinical team members, and clearly communicate results both internally and externally.
- Oversee ongoing medical monitoring of clinical trials.
Education / Skills / Experience Sought:
- An MD degree is required.
- Pharma/biotech industry experience in clinical-stage Drug Safety is required, with specific experience in Oncology strongly desired.
- FDA and/or other Global Health Authority interaction experience is a plus.
- NDA/BLA/EMA submission experience is a plus.
- Previous experience building and leading global safety/PV teams is a plus.
- Our client is looking for a hands-on Drug Safety/PV professional that can serve as both a strategic leader while also “rolling up their sleeves and getting into the weeds.” Candidates must have a can-do attitude as they are not looking for a bureaucratic leader, but rather someone with a willingness to work in a player-coach capacity (i.e. “hands-on”, roll-up-your-sleeves and pitch-in wherever necessary). This is a start-up Biotech and that requires the right attitude and approach.
Thomas Fascia, Partner
email@example.com – P 973-656-0220 x717
CORNERSTONE SEARCH GROUP – Life Sciences Executive Search
6 Campus Drive | Suite 301 | Parsippany, NJ 07054 USA
www.cornerstonesg.com | 973.656.0220
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Keywords: “patient safety” PV Risk Management SD ED VP