Associate Director/ Medical Director, Clinical & Translational Research Oncology
Sam Whyley-Smith is recruiting for a Associate Director / Medical Director, Clinical & Translational Research Oncology to join a highly innovative Biotechnology Company based in Cambridge.
Our client is a highly innovative biotech focused in the discovery and development of novel targeted therapeutics for the treatment of both solid tumour cancers and hematological malignancies, including AML. Following expansion of their portfolio from significant investment they are searching for an experienced Physician to lead early clinical and translational projects.
The successful candidate will actively participate in all aspects of Clinical and Translational Research working collaboratively with the Discovery, Preclinical and Clinical Study Team and Project Team contributing to the strategic planning and execution of Clinical Development Plans for compounds in hematology and oncology clinical development. This individual will be responsible for providing input used for the design of clinical study concepts and writing of clinical trial protocols, IBs, CSRs, and scientific presentations to the highest scientific standards. This individual will be the primary Medical Monitor for all clinical studies conducted under his/her responsibility and contribute to/provide medical and biomarker data review, analysis, and interpretation from clinical studies.
- Work cross-functionally to define, plan and provide Medical Monitoring to clinical development studies including out of hours coverage.
- Contribute scientific expertise in translational medicine to study teams, project teams and management
- Collaborate with the discovery, preclinical and translational groups to assure alignment of translational medicine strategy
- Contribute medical expertise and provide strategic and clinical input to discovery projects
- Collaborate with Project Management, Clinical Operations, Clinical Science, and Medical Writing departments in the preparation of clinical development plans, protocols, investigator brochures, annual IND reports, clinical study reports, manuscripts, and different scientific presentations.
- Extensive interaction with academic thought leaders to optimize clinical development strategies and clinically manage the conduct of the clinical trials
- For assigned programs/studies, lead the efforts in preparing for conference presentations such as AACR, ASCO, and ASH, and writing and reviewing manuscripts based on the database and CSR
- This individual will be responsible for the clinical and medical content of all clinical and regulatory documents and will ensure the medical and scientific accuracy of all study-related documents
- Responsible for review and analysis of clinical data including safety monitoring in collaboration with Drug Safety
- Ability to organize and lead clinical development advisory boards and safety monitoring boards
- Ensure Clinical Study Team compliance with FDA, EMEA, ICH and GCP guidelines
- Review and sign-off clinical documents with respect to medical relevance.
- MD/PhD degree; oncologist or hematologist-oncologist
- Board certified with an active medical license is desirable, but not required
- Clinical research experience working for a biopharmaceutical organization or extensive relevant academic experience
- Strong background in the area of oncology translational research
- Familiar and comfortable with clinical concepts, practices, and regulations regarding clinical trials
- Familiar with data processing methods plus general knowledge of clinical and translational medicine, oncology, and medical terminology
- Ability to interact with clinical monitors and physician investigators, and build constructive, trusting and respectful relationships with colleagues at all levels within and outside the organization
- Must possess excellent leadership, communication, and organizational skills and be able to exercise sound critical thinking and problem-solving skills.
For more information or to apply for this position, please contact Sam Whyley-Smith on 01246 5800 40 or email email@example.com. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 47088 in all correspondence.