Sr. Director, Clinical Science | Cutting-Edge I-O Cell Therapies | Exciting Biopharma | Boston Area

Cornerstone Search Group
Published
September 15, 2020
Location
Greater Boston Area, United States
Category
Job Code
bcsBH2793csg
Contact Email
bskurka@cornerstonesg.com

Description

Sr. Director, Clinical Science | Cutting-Edge I-O Cell Therapies | Exciting 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).  In this new role, 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 or more of the company’s highest-profile cell therapy programs.

ATTRACTIVE FEATURES ABOUT THIS COMPANY & OPPORTUNITY:

  • Key Role on High Profile Cell Therapy Program: 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.).
  • 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.

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 degree in a scientific discipline (PhD, PharmD, Master’s).
  • At least 8-10 years of relevant clinical research/clinical development and trial management experience within the pharmaceutical/biotech industry.
  • Sufficient grounding in the principles of the scientific method of the immune system, coupled with experience in cell therapy/oncology drug development to lead internal and external projects across the spectrum of R&D (early and late phase).

CONTACT:

Brian Skurka | Partner

E: bskurka@cornerstonesg.com | P: 973-656-0220 x738

LinkedIn: https://www.linkedin.com/in/brianskurka1

CORNERSTONE SEARCH GROUP, LLC

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www.cornerstonesg.com

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Keywords: Program, Asset, Oncology, Hematology, Immuno-Oncology, Cancer, Tumor, Project, IND, NDA, Protocol, Clinical Development Plan, CDP, Clinical Study Report, CSR, Filing, Submission, Regulatory, Clinical Research, Clinical Development, Global, Clinical Science, PhD, Ph.D., Doctorate, Team, R&D, Research, Scientific, Medical, Senior Director, Sr. Director, Cell Therapy, CAR NK, immunology

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