Global Head (ED or VP level) Regulatory Affairs – Oncology | Cutting-Edge Biotech | Boston area: RETAINED SEARCH
This is a very attractive newly created leadership position reporting directly to the C-level. You will have responsibility across both “big picture” global oversight/strategy and “hands-on” activities and will truly have the ability to directly influence/impact company strategy (Regulatory, Clinical Development, etc.) at the highest level. As a key member of the clinical leadership team, you will provide strategic regulatory leadership/input for the global programs within the Company’s oncology portfolio, as well as having the opportunity to continue to build/grow the Regulatory team.
Our client is an exciting global biotech company with an innovative focus within a specialized/targeted technology across the immuno-oncology space and has multiple assets in different stages of clinical development. This is a great opportunity to join the Company at the early stage in its growth and have the ability to truly influence and impact the direction of the organization.
Location: Boston, MA
Attractive Features about this Company & Opportunity:
- Exciting Newly-created Leadership Role: You will have the opportunity to create what and how the Regulatory 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 Executive Director or Vice President-level.
- 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 (with multiple assets in different stages of development) and 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 up a vast domain for discovering innovative new cancer medicines.
- Work Flexibility: Our client offers the flexibility to work two days a week from home, given the mutual respect and expectation that all employees are engaged and dedicated to bringing significant value to the organization.
- Excellent Hiring Manager: You will report directly to the Chief Development Officer (whom we know personally) 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.
The Head, Regulatory Affairs is responsible for developing the global regulatory strategy for projects within the Oncology portfolio. In addition to strategic regulatory leadership and input for the various programs, the individual will provide tactical operational support for these programs which are at various stages of development. This individual will also ensure effective communication with global health authorities and will represent the Company with business partners including companion diagnostics developers, CROs, external business development alliance partners, and various business consultants.
- Leads, develops and implements the global regulatory strategy for the Company’s projects in Oncology.
- Represents Regulatory Affairs organizationally as a member of the clinical leadership team, and on cross functional project teams, providing regulatory input and tactical support for global projects: creating regulatory development plans for complete and accurate IND/CTA submissions; ensuring that clinical trials are designed to meet regulatory requirements; and guiding programs to successful NDAs and MAAs in support of global registration submissions.
- Serves as the Company face of regulatory with US FDA, CHN CDE, EMA and other global health authorities for the projects.
- Leads the Regulatory Affairs team for the various project development teams, including provision of RA clinical, RA CMC, and RA Operations support using extensive knowledge of US, EU, CDE/cFDA and ICH regulatory requirements and the ability to apply knowledge both strategically and operationally to develop regulatory strategies for the projects.
- Coordinates and contributes/authors submissions to FDA, CHN CDE or EMA in support of proposed and ongoing development programs (e.g., new IND/BLA submissions, IND/BLA amendments, Scientific Advice requests, etc.).
- Provides support to regulatory reviews for due diligence initiatives, including opportunity and risk assessment.
- Develops and leads the hiring strategy to support growth of the Regulatory function and the clinical development pipeline advancement.
Education & Experience:
- An advanced degree (PhD, MD, MSc, MPH, PharmD) in Chemistry, Biochemistry, or related pharmaceutical science is required.
- Oncology experience is required.
- 10+ years in the pharmaceutical/biotech industry, with significant regulatory experience in Oncology and Regulatory Affairs leadership experience.
- Experience building and leading global regulatory teams is desirable, experience in filing of INDs and CTAs in Asian markets.
- Companion Diagnostics Regulatory Affairs experience is desirable, including experience and knowledge of clinical trial assay and companion diagnostics development and support of IDE submissions and associated commitments to clinical development programs.
- Experience with supporting early and late phase development projects, including filing of IND and CTA submissions and NDAs, MAAs.
- Proven ability to work effectively in a fast-paced entrepreneurial environment, to be self-motivated, and to communicate effectively with senior management.
- Willingness to work in a player-coach capacity (i.e. “hands-on”, roll-up-your-sleeves and pitch-in whenever necessary).
Thomas Fascia, Partner
email@example.com - P 973-656-0220 x717
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