Lead, Clinical Science R&D | Cutting-Edge I-O Cell Therapies | Exciting Global Biopharma | Boston Area
This is an attractive opportunity to join an exciting and growing global biopharma company with a very impressive and diverse early-late stage oncology/I-O development pipeline (15+ assets which includes multiple innovative NMEs and I-O, Cell & Gene Therapies). You will be a key member of the Global Clinical Science/Development Team developing novel/breakthrough cell therapy products in the immuno-oncology area, and be an integral part of collaborating in key discussions that will influence the strategic scientific and operational decisions that will impact the successful clinical development of the company’s high-profile I-O cell therapy programs.
ATTRACTIVE FEATURES ABOUT THIS COMPANY & OPPORTUNITY:
- Enjoy the Best of Both Worlds: Enjoy the minimal layers of management and swift decision making of a biotech culture, while also enjoying the financial stability and the financial strength of an established global biopharma (i.e. more financial and human capital resources, more assets, better compensation and benefits, etc.).
- Key Role / Ability to Impact: You will play a key role that will influence the major strategic scientific and operational decisions that will impact the successful clinical development of your Global Development Team’s I-O Cell Therapy program.
- Cutting-Edge Therapeutics: You will be an integral part of developing an extremely promising new I-O cell therapy discovered by one of the most respected and revered Cancer Academic Research & Medical Centers in the world.
- Excellent Hiring Manager: Report into a very highly-regarded and well-respected hiring manager/Department Head (whom we know very well and have an excellent relationship with).
- Strong Collaborations / Financial Strength/ R&D Spend: Join an oncology company with a track record of establishing multiple collaborations with top oncology academic research centers, and with other innovative biotech companies too in a highly competitive marketplace. This company has strong revenues, profits, cash & market cap that invests heavily in its annual R&D.
- Very Competitive Compensation/Benefits: This company offers a very competitive compensation package and an extensive benefits package (strong LTI, 401k company contributions, employee stock purchase plan & much more).
RESPONSIBILITIES IN A NUTSHELL:
- Lead the scientific and medical review of clinical data across multiple studies in immuno-oncology and participate in the creation, maintenance, and execution of clinical development plan that will result in the regulatory approval of the compound in multiple regions.
- Represents Clinical Science on US/EU Development Teams.
- Participates in a multi-disciplinary, matrix team ensuring that scientific issues are appropriately considered with respect to highly complex data findings.
- Supports the Global Development Team to ensure that the US/EU Development Team activities are aligned with the global strategy.
- Provides critical evaluation of the development strategy to maintain a state-of-the-art development plan that is competitive and consistent with the latest regulatory requirements, proactive identification of challenges, and development of contingency plans.
- Contributes to high impact global decisions: monitoring and interpreting data from ongoing internal and external studies and making recommendations that impact regional and global development such as “go/no go” decisions or modification of development plans or study designs.
- Contributes to the development of protocol synopsis, obtaining scientific and corporate review committee approval including presentation and defense of the Synopses during review committee meetings, review and approval of documents related to study protocols.
- Provides scientific contributions and overall content approval of written responses required by IRB / Ethics Committees and critical study training meetings.
- Responsible for review of study data, interpretation of results and communication of study conclusions within the company.
- Influences establishment of strategy for assigned compound, and the development of documents required to outline the company’s positions on research programs or regulatory applications.
- Interacts directly with research division based on pertinent clinical and development expertise to provide knowledge / understanding of market environment.
- Contribute to Clinical Development Plan, protocol, IB, eCRF, SAP, CSR development, as well as other critical study documents.
EDUCATION & DESIRED EXPERIENCE:
- Advanced scientific degree (Master’s, PharmD, PhD).
- 7+ years of relevant clinical research and/or clinical development experience ideally within the pharmaceutical/biotech industry.
- Sufficient grounding in the principles of the scientific method of the immune system, coupled with experience in oncology/cell therapy drug development to lead internal and external projects across the spectrum of R&D (early and late phase).
Brian Skurka | Partner
E: email@example.com | P: 973-656-0220 x738
CORNERSTONE SEARCH GROUP, LLC
Six Campus Drive | Suite 301 | Parsippany, New Jersey 07054 USA
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Keywords: Program, Asset, Oncology, Hematology, Immuno-Oncology, Cancer, IND, NDA, Protocol, Clinical Development Plan, CDP, Clinical Study Report, CSR, Filing, Submission, Regulatory, Clinical Research, Clinical Development, Global, Clinical Science, R&D, Scientific, Clinical Research Scientist, Director, Lead, Cell Therapy, CAR T, immunology