Associate Director, Clinical Research Science | Innovative I-O Cell Therapies | Fast Growing Biopharma | Boston area
This is an exciting opportunity to join an attractive and rapidly 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 “first/best-in-class” I-O Cell Therapies). As a key member of the Global Clinical Science/Development Team within this new/growing Cell Therapy Business Unit, you will utilize your clinical science and study management experience 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 highest-profile programs.
ATTRACTIVE FEATURES ABOUT THIS COMPANY & OPPORTUNITY:
- Focus on Cutting-Edge Cell Therapies: 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.
- Great Time to Join: This is a perfect time to join as the organization is growing fast and furious and positioned very well for sustainable growth – making it an excellent career 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.).
- 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.
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.
- 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.
- Participates in a multi-disciplinary, matrix team ensuring that scientific issues are appropriately considered with respect to highly complex data findings.
- 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 (PhD, PharmD or MSc).
- 7+ years of relevant clinical research and/or clinical development experience ideally within the pharmaceutical/biotech or related 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 – Life Sciences Executive Search
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