VP (Head), Global Regulatory Affairs | Public Oncology Biotech | New Jersey: RETAINED SEARCH
SUMMARY: Cornerstone Search Group has been by retained by a uniquely attractive Oncology / Heme-Onc biotech for a VP, Head of Global Regulatory Affairs position reporting to the C-level and leading regulatory strategy and operations across their large self-discovered pipeline featuring multiple assets entering late-phase global development for filings in the US, EU and Asia.
This is a “best of both worlds” opportunity because you will simultaneously enjoy the benefits of a smaller, entrepreneurial environment while having the comfort and security of working for a well-funded, publicly-traded company with a large self-discovered pipeline addressing a diverse range of solid and liquid tumor types. Furthermore, our client has in place strategic collaborations with several top pharma companies.
Our client is seeking an experienced RA professional with the ability to work across a dynamic, global environment and serve as the RA voice across the executive leadership team, cross-functional internal teams, as well as all with regulatory agencies (FDA, EMA, PMDA, etc.). You will serve as the RA strategic leader, navigating a critical stage of growth within the organization to include multiple regulatory filings in the near future. While you will have a team of direct reports, this position requires a hands-on leader with the ability to influence across the organization and externally.
Unlike at larger pharmas, this role provides the opportunity to make an immediate strategic and meaningful impact in a growing development organization on current and future clinical programs as this company has a prodigious clinical and pre-clinical pipeline.
TITLE: Vice President (Head), Global Regulatory Affairs
LOCATION: New Jersey. There is partial work@home flexibility.
Our client is situated within reasonable commuting distance of all areas in North and Central NJ, as well as Eastern Pennsylvania, Southern New York State, and New York City. Plus, they allow partial work@home. This area of New Jersey is near many other pharmas (and Fortune 500 companies) as well as to New York City via public transportation, has a diverse international culture, has many top-ranked public school systems, and feature diverse places to live (small cities, suburbia, farm/horse country).
RELOCATION BENEFITS: Our client can provide relocation assistance.
ATTRACTIVE FEATURES ABOUT THIS POSITION AND COMPANY:
- High Visibility/Strong Stability: In this smaller environment, you’ll have direct interaction across the senior-most executive leadership. As compared to larger pharmas, you will be able to interact at the highest level and just get things done as opposed to waiting for meetings upon meetings to try to accomplish anything.
- Large & Diverse Pipeline: Our client’s self-discovered pipeline features multiple candidates in each stage (Phase I – III) and addresses a wide range of solid and liquid tumor indications.
- Strong Funding: This public biotech has the necessary cash reserves to support the development of its large pipeline.
- Share in the Company’s Success: This publicly traded company has an extremely attractive long-term incentive stock plan with both RSUs and Stock Options. With this company’s pipeline in a position to yield multiple products submissions over the next 1-2 years, this is an opportunity to share in the success of a company at a critical stage in its growth cycle.
RESPONSIBILITIES: CHALLENGES, EXPECTATIONS AND DELIVERABLES FOR THIS POSITION:
- As the leader of RA, you will develop the Regulatory Affairs strategy and operational development for all programs.
- Develop the current RA team and add to it as the company advances its pipeline.
- Build out the department’s SOPs, technical capabilities, etc.
- Manage external vendors.
- Align regulatory strategy globally related to development plans as well as to specific disease states/trends.
- Manage the Regulatory activities in order to meet FDA, EMA, PDMA and other global health authority requirements for all clinical (IND to NDA/BLA) and post-marketing activities.
- Manage the preparation of regulatory submission documentation, including NDA/BLA preparation, INDs, Drug Safety Update Reports, annual reporting requirements, regulatory agency materials and global clinical trial applications (CTAs).
- Manage compliance reviews of materials for regulatory submission, as well as for the use in advertising and/or promotion of products.
- Define gaps and limitations in regulatory documentation and facilitate mitigation actions to address them – both product development and clinical development.
- Coordinate critical reviews and provide strategic input on regulatory filing documents.
- Provide regulatory strategy input and guidance to business development activities.
- Provide input to the departmental budget based on expected deliverables for the nominated fiscal year.
DESIRED SKILLS / EXPERIENCES / ACCOMPLISHMENTS / QUALITIES / EDUCATION:
- 10+ years of relevant Regulatory Affairs experience, ideally this will include both US and global experience.
- Prior NDA/BLA submission experience required. MAA and/or PDMA submission experience is a plus.
- Prior experience leading clinical stage and submission negotiations with health authorities.
- Oncology experience is required.
Thomas Fascia | Partner
P: 973-656-0220 x717
CORNERSTONE SEARCH GROUP - Life Sciences Executive Search
Six Campus Drive | Suite 301 | Parsippany, New Jersey 07054 USA
www.cornerstonesg.com | 973.656.0220
Prior Examples of Retained Search Assignments:
- CEO | specialty start-up
- US CEO | established European small pharma
- CMO | late-stage public biotech
- CMO | mid-size pharma
- CSO | mid-size global biotech
- President/US Commercial Head | OSD generics
- SVP, Head of Global Medical Affairs | mid-size oncology company
- SVP, Head of Global Regulatory Affairs | late-stage Israeli biotech
- Group VP, Global Commercial Head | API Business Unit | Indian pharma
- VP, Global Commercial Strategy – Early Pipeline | top rare disease biotech
- VP, Global Head of Biometrics | NYC commercial-stage biotech
- VP, Head of Regulatory Affairs | Boston biotech
- VP, Head of Regulatory Affairs | NYC commercial-stage biotech
- VP, Head of R&D Operations | Boston biotech
- VP, Head of Health Economics & Outcomes Research | Top CNS specialty pharma
- VP, Head of Real-World Evidence | Top 5 pharma
- VP, Head of Heme/Onc Clinical Research | Public oncology biotech
- Executive Director, Head of Global Clinical Pharmacology | Public oncology biotech
- Executive Director, Head of US Drug Safety & PV | Chinese oncology biotech
- Medical Director, Clinical Development | Boston biotech
- Medical Director, Translational Medicine, Neuroscience | Top 5 Biotech
Keywords: cancer New York Pennsylvania I-O immunooncology immuno-oncology hematology immune-oncology