Head of Scientific Affairs
ProClinical is advertising a vacancy for a Head of Scientific Affairs position with a global biopharmaceutical company in Cambridge. The organisation focuses on developing treatments in the fields of oncology, cardiovascular and respiratory fields. This position offers an exciting opportunity to work with an innovative company whose medicines are used by millions of patients worldwide.
- Develop the global scientific and regulatory plan for patient identification solutions for Oncology products and partner with all relevant cross-functional stakeholders to execute the Oncology Diagnostics medical strategy
- Develop KEE advocacy and KEE engagement plans in laboratory segments. Lead Scientific Advisory boards and other diagnostics activities at scientific events including major Congresses and Forums.
- Interact with professional laboratory societies and advocacy groups for coordination of activities around biomarker education and awareness.
- Design and lead medical educational programs with the objective to establish biomarker clinical utility in various HCP segments: oncologists, pathologies, geneticists.
- Collaborate with Oncology Medical Affairs to develop and implement plans for RWE generation (ESR, epidemiology studies) in laboratory segments and facilitate their implementation worldwide.
- Develop Scientific and Regulatory strategies for biomarker Lifecyle management and biomarker adoption on various testing platforms worldwide.
- Support countries with development of local market specific solutions. Lead implementation of local bridging and quality assurance and accreditations studies required by local regulations.
- Track guidelines and regulatory landscape for present and future Diagnostic testing in key markets.
Skills and Requirements
- MD/DO degree from an accredited medical school OR PhD OR PharmD
- 5 years of medical affairs experience in global diagnostics or equivalent
- Strong foundation in Life Sciences e.g. Molecular Biology, Pathology
- Experience with clinical companion diagnostic development
- 5+ years Medical Affairs experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO) that includes collaborations with integrated delivery networks, accountable care organizations, and/or payers
- Knowledge of Good Clinical Practices (GCP) and global regulations and guidelines
- Outstanding written and verbal communication skills
In case you have difficulty in applying or if you have any questions, please contact Tom Russell on +44 203 8246 104 or upload your CV on our website - www.proclinical.com/send-cv
A full job description is available on request.