Head of Scientific Affairs - Global Oncology Diagnostics
Location: Cambridge, UK or Gaithersburg, USA
At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. We’re focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life.
Role: The Scientific Affairs Director, Global Oncology Diagnostics is accountable for the development and execution of global scientific strategy for AstraZeneca oncology diagnostics solutions worldwide. The Director of Scientific Affairs supports the mission of AstraZeneca Oncology in three domains:
- Maximizing Global Biomarker Adoption
- Generating Clinical Evidence in collaboration with Oncology Medical Affairs
- Leading Medical Education for lab communities
The Scientific Affairs Director will work closely with cross-functional partners, regions and countries for coordination of all Oncology diagnostic activities and will be responsible to:
- Develop the global scientific and regulatory plan for patient identification solutions for AstraZeneca Oncology products and partner with all relevant cross-functional stakeholders (Oncology Medical Affairs, Precision Medicine, OBU Franchises, GPT and OBU market teams) 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 Lifecycle 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.
- Partner with external stakeholders in order to ensure diagnostics solutions are established in laboratories in time for launch
MD/DO degree from an accredited medical school or PhD or PharmD
Deep medical affairs experience in global diagnostics or equivalent
- MD plus accredited fellowship in Pathology
- Strong foundation in Life Sciences e.g. Molecular Biology, Pathology
- Experience with clinical companion diagnostic development
- Membership in diagnostics professional societies
- Proven Medical Affairs experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO) that includes collaborations with integrated delivery networks, accountable care organizations, and/or payers
- Experience with stakeholder engagement and interactions (KEE, advocacy groups, payers)
- Familiarity with global regulatory organizations, guidelines, and practices
- Knowledge of Good Clinical Practices (GCP) and global regulations and guidelines
- Knowledge of pharmaceutical product development, product lifecycle, and commercialization processes, including but not limited to, clinical operations, commercial, regulatory, and medical affairs specifically related to companion diagnostics
- Track record of solving problems while exhibiting sound scientific/medical judgement and a balanced, realistic understanding of issues
- In-depth understanding of scientific method and clinical applications based on medical, scientific, and practical rationale
- Track record of success collaborating in matrixed cross-functional teams
- Outstanding written and verbal communication skills
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.