Executive Director/Senior Director, Regulatory Affairs – Immuno-Oncology | Well-funded Biotech- Boston: RETAINED SEARCH
Cornerstone is working exclusively with a well-funded, innovative start-up Biotech focused within specialized/targeted Immuno-oncology approaches. We have a long-standing relationship with the Chief Development Officer (hiring manager) who is looking to fill a newly created position to lead Global Regulatory Affairs. This is an opportunity to join a start-up Biotech before they grow larger. You will receive a strong stock option package and have the opportunity to truly drive value for the Regulatory Affairs function to include: strategy, operations, cross-functional leadership, executive-level collaboration, etc. Our client also respects talent and the realities of everyday life and allows their people the opportunity to work two days a week from home.
Location: Boston, MA.
Attractive Features about this Company & Opportunity:
- 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.
- 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).
Brian Skurka, Partner
firstname.lastname@example.org - P 973-656-0220 x738
Thomas Fascia, Partner
email@example.com - P 973-656-0220 x717
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