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Clinical Development Director

1 month ago

Étreux, Hauts-de-France, United States CK Group Full time

Director/Snr Director, Clinical Development, Melanoma

The ideal candidate will be a medical professional with a specialization in oncology, preferably board-certified, and a deep understanding of the solid tumor landscape. They should have a proven track record of leading and facilitating late-stage clinical development strategic planning and be accountable for the design and medical oversight of these studies.

The company is a pioneering, commercial-stage T cell receptor biotechnology company with a strong early pipeline and a well-respected leadership team in the Oncology space.

This role will be based on the East Coast, with the ideal candidate being within commutable distance of the offices to have some onsite presence.

Key Responsibilities:

  • Lead and shape future clinical development strategy and clinical development plans, working closely with Development and Discovery Program Leads and counterparts in Regulatory, Clinical Development, Clinical Operations, Biostatistics, Clinical Pharmacology, Medical Affairs, Commercial, Non-clinical and Discovery Research for assigned studies
  • Assure clinical development plans are comprehensive, include key decision points, timely readouts, and risk mitigation for both near and long-term goals
  • Design high-quality & innovative clinical trial protocols (including all supporting documents such as Investigator's Brochure, informed consent, etc) for lead Oncology target programs that are aligned with the Clinical Development Plan and overall product strategy
  • Establish and maintain strong relationships with key opinion leaders and partners, to facilitate and support external collaborations
  • Provide medical oversight of clinical studies, implementation, medical/safety monitoring, medical data review, results interpretation, and reporting for assigned studies
  • Provide strategic clinical leadership to development teams, including generation of integrated product development plans that incorporate scientific rationale, regulatory input, and advice from medical, patient advocacy groups and payors appropriate for assigned studies
  • Help build and manage the relationships with relevant CROs, facilitate thorough understanding of clinical studies, assist in patient recruitment, and help assure trials are executed on time and within budget
  • Contribute to the regulatory strategy, preparation, and review of regulatory submissions, response to IRB/EC questions, and participate in global health agency meetings
  • Contribute to the development of publication plans, present clinical data at key meetings and publish in high-impact journals
  • Contribute to Business Development activities as requested

Education & Qualifications

  • MD or MD/PhD with research training or experience
  • Working knowledge of basic and clinical science
  • Strong understanding of pharmacokinetics, biomarkers, statistical principles, and regulatory requirements and demonstrated experience integrating these disciplines in the context of drug development.
  • Broad understanding of oncology disease area; experience in immuno-oncology and oncology/hematology fellowship training highly desirable;
  • At least 5 years of relevant experience in clinical drug development in pharmaceutical industry (must include experience conducting late phase trials)
  • At least 2 years of experience as a medical monitor in a biotechnology/ pharmaceutical company, and/or CRO.

This is an exciting opportunity to join a pioneering company in the Oncology space and contribute to the development of innovative treatments for melanoma.

The ideal candidate will have a strong understanding of the solid tumor landscape and a proven track record of leading and facilitating late-stage clinical development strategic planning.

The company offers a dynamic and collaborative work environment, with a strong focus on innovation and excellence.

For more information, please contact Amy Lloyd at alloyd@ckscience.com or apply to the position.

It is essential that candidates have the right to work in the US.