The Director/Snr Director, Clinical Development will be a MD with a specialisation in oncology, ideally board-certified, and a deep understanding of the solid tumor landscape. Those who are well-versed in the current and emerging treatments for melanoma is preferable and have demonstrated the ability to lead and facilitate 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 with a fantastic well respected leadership team in the Oncology space.
This candidate will be East Coast based, ideally within commutable distance the offices to have some onsite presence.
Site Locations: MD and PA
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.
For more information, please contact Amy Lloyd at alloyd@ckscience.com or apply to the positon.
It is essential candidates have right to work in the US.