Senior Director, US / Global Regulatory Affairs – Hematology / Oncology
10 Asset Public Biotech | New Jersey
SUMMARY: Cornerstone Search Group is partnering again with a uniquely attractive biotech client on a position newly created due to their continued growth driven by their now 10 clinical-stage asset pipeline for solid and liquid tumor types. We’ve helped our client hire multiple people from top pharmas who were attracted to our client’s strong culture with fast decision making, experienced leadership, funding far better than a typical biotech, it's large self-discovered pipeline, and because it's already publicly traded and has a very strong LTI program (stocks and options). The Sr. Director of US/Global Regulatory Affairs will have strategic and operational leadership responsibilities globally ranging from IND to NDA/BLA submissions in the US, EU, and Japan.
Cornerstone has assisted our client with hiring several of their key leaders and have developed a strong relationship their C-level and HR from helping them hire not just experienced people, but also “good” people as they put a great deal of emphasis on finding the right cultural fit for the team. 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 public company with a large, diverse, self-discovered pipeline addressing a range of solid and liquid tumor types.
TITLE: Senior Director, Regulatory Affairs (US & Global)
LOCATION: New Jersey with 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. This area of NJ 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 & COMPANY:
- High Visibility/Strong Stability: In this smaller environment, you will have direct interaction across the senior-most executive leadership. As compared to larger pharmas, you will be able to interact with the highest levels and just get things done as opposed to waiting for meetings upon meetings to try to accomplish anything. While public, our client continues to be backed by its founding parent company (a $40Bn global entity), and as such, they do not need to rely upon Wall Street for funding.
- 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 consisting of both stocks and 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.
SKILLS, EXPERIENCES & MOTIVATIONS SOUGHT:
- 7+ years of relevant Regulatory Affairs experience, ideally including both US and global experience.
- Prior NDA / BLA submissions experience.
- Oncology experience (solid or liquid tumor) is required.
- The ability and desire to work in a smaller, fast-paced environment with the ability to influence across the organization to include C-level executives.
Thomas Fascia | Partner
E: firstname.lastname@example.org | 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 Regulatory Affairs | Boston biotech
- 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 | 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: Heme-onc BLA Fast-Track Fast Track Orphan Solid Tumor Liquid Tumor hematologic malignancies Sr. Director United States IND Japan Europe Marketing Authorization Application EMA EU Japan Japanese PDMA China Chinese