Sr. Director/Dir, Clinical Science R&D | Innovative I-O Cell Therapies | Exciting & Growing Biopharma | Boston Area
This is an exciting new opportunity to join an attractive global biopharma company that has an extremely impressive and diverse early and later-stage oncology/I-O development pipeline (15+ assets which includes multiple innovative NMEs and I-O, Cell & Gene Therapies). This is a brand new position where you will be a key member of the Global Clinical R&D Team developing novel/breakthrough cell therapy products in the immuno-oncology area. You will 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 one of the company’s highest-profile cell therapy programs.
ATTRACTIVE FEATURES ABOUT THIS COMPANY & OPPORTUNITY:
- Key Role & Ability to Influence: 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.
- 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.).
- Fantastic 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).
- 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.
- 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:
- Provides the strategic leadership and scientific direction to ensure that clinical development programs are appropriately designed to support Asset Strategy and company/TA objectives.
- Responsibility for development decisions assessing and integrating the input from various disciplines to create, maintain, and execute a clinical development plan that will result in the regulatory approval of the compound in multiple regions.
- Influence leadership decision-making by suggesting strategic direction and providing expert therapeutic area and clinical development input. Provides clinical expertise and interacts with regulatory agencies such as the FDA and EMEA.
- Provides scientific expertise to functional area representatives on disease state, study design, and scientific rationale in clinical studies for cell therapy/immuno-oncology portfolio.
- Provides on-going 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, proactively identifying challenges, and developing contingency plans to meet them.
- Recommends high impact decisions. Assesses the scientific implications and makes recommendations that impact regional and global development such as “go/no go” decisions or modification of development plans or study designs.
- Assumes primary responsibility for the completion of protocol synopsis, obtaining scientific and corporate review committee approval including presentation and defense of the Synopses during review committee meetings.
- Establishes and maintains interactions with KOLs, and provides leadership in meetings and negotiations with key opinion leaders, establishment of strategy for assigned compounds.
- May represent the department in face to face interactions with FDA and EU regulatory agencies, providing clinical expertise related to cell therapy/I-O therapeutic area.
- Exercises foresight and judgment in initiating, planning, organizing and guiding highly complex projects across the clinical development lines.
EDUCATION & DESIRED EXPERIENCE:
- Advanced scientific degree (Master’s, PharmD, PhD).
- At least 8 years of clinical research and/or clinical development experience 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
P: 973-656-0220 x738
Cornerstone Search Group, LLC
Six Campus Drive | Suite 301 | Parsippany, New Jersey 07054 USA
Recently Completed Retained Searches by Cornerstone:
- CEO | US Country Head, Specialty Pharma
- CEO | Start-up sterile injectable pharma
- CMO | NYC biotech, Cellular Therapy
- CMO | Reports to CEO | Leads 100+ | Early/later-stage Biotech | Boston area
- CSO | Reports to President | Leads 850+ | Hem/Onc/IO TAs | EU based
- SVP, Global Medical Affairs, Oncology | Reports to President | Leads 50+ | NYC area
- SVP, Translational Medicine & Early Development, Oncology | Boston Biotech
- VP, Oncology Drug Development | Reports to CMO | Leads 20+ | Early/later-stage Biotech | Boston
- VP & Head of Research & Development, Oncology | Reports to CMO | Early-stage Biotech | NYC
- VP, US Medical Affairs, Oncology | Reports to Head of GMA, Oncology | Leads 45+ team | NYC area
- VP, Head of Real-World Evidence | Top 5 Pharma
- VP, Head of Clinical Operations
- ED, Early Development, IO | Reports to Head, IO Early R&D | Top 10 Onc/IO Co | Philadelphia area
- ED, Clinical R&D, Onc | Reports to Head. Clinical R&D Onc | Preclinical Onc/IO Biotech | NYC area
- ED, Head of Program Management | Boston Biotech
- SD, Clinical Research, Oncology | Boston Area Biopharma Oncology Leader
- SD, Clinical Development, Immuno-Oncology | Cambridge Area Global Oncology Leader
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