Senior Director, Clinical Development (PhD, PharmD, MS) – Oncology/Hematology - Public Biotech - large self-discovered pipeline - top long-term incentives - New Jersey: RETAINED SEARCH
SUMMARY: Cornerstone Search Group has been retained by a uniquely attractive Oncology/Hematology biotech for a Senior Director, Clinical Development position that is newly created due to the advancement of their large self-discovered pipeline featuring multiple assets entering late-phase global development. 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 and very competitive long-term incentive/compensation packages. Furthermore, our client has in place strategic collaborations with several top pharma companies.
As a key member of the Clinical Development team, you will work closely with Clinical Development Asset Leads and the CMO, all of whom have strong industry experience, to ensure that all phases of clinical development, including the design and implementation of clinical protocols and development plans, are achieved successfully and expeditiously.
Unlike at larger pharmas, this role provides the opportunity to make a strategic and scientific impact in a growing development organization on current and future clinical programs as this company has a prodigious clinical and pre-clinical pipeline.
The ideal candidate will help to build clinical expertise and be able to collaboratively design, plan, implement, analyze, and report clinical studies. This is a unique opportunity to expand your knowledge in the scientific and research aspects in oncology/hematology across multiple areas working on several assets, through close interactions with the R&D organization.
TITLE: Senior Director, Clinical Development
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 AND COMPANY:
- Extremely Attractive Long-term Incentive: This publicly traded company has a long-term incentive stock plan that is incredibly generous and competitive. 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.
- High Visibility: In this smaller environment, you’ll have direct and frequent interaction with the CMO and Heads of Reg Affairs, Drug Safety, etc. Their culture fosters collaboration and welcomes input. This environment allows someone to make a real impact on programs and in building this company’s infrastructure and SOPs, which is hard to achieve in slow-moving, multi-layered, and oft-politicized larger pharma.
- 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.
RESPONSIBILITIES: CHALLENGES, EXPECTATIONS AND DELIVERABLES FOR THIS POSITION:
- Work with senior level Clinical Development leadership (including the CMO) to direct and support the planning and implementation of clinical programs at all stages, with an initial focus on a Phase III global program.
- Review, analyze and interpret study results, including exploratory endpoints, ensuring appropriate data review and accurate data reporting are completed.
- Interpret safety and efficacy results data, including gathering, analyzing, reviewing, interpreting, and providing preliminary assessments and recommendations.
- Contribute to database lock, statistical analysis plans, and the preparation of CSRs, IBs, INDs, NDAs (US, EU, Japan) and other regulatory submissions.
- Provides support for advisory boards, consultant meetings, and investigator meetings, including preparation and/or delivery of presentations.
- Partner with CPMs to ensure study execution is progressing per timelines, milestones, and expected deliverables.
- Develop and maintain SOPs and working practices.
DESIRED SKILLS / EXPERIENCES / ACCOMPLISHMENTS / QUALITIES / EDUCATION:
- PhD / PharmD / MD preferred
- Ideally 5+ years of oncology clinical development experience that can be a mix of clinical research science along with clinical operations, medical writing, etc.
- Phase III and NDA/BLA experience is a plus.
- Leadership and influencing skills.
- The demonstrated ability to anticipate, recognize and resolve problems/issues that may impact timelines and deliverables
Thomas J. Fascia | Partner
firstname.lastname@example.org | 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 CRS CRP New York Pennsylvania I-O immunooncology immuno-oncology clinical research scientist