Senior Director, Clinical Development, Oncology
Senior Director, Clinical Development, Oncology
Waltham, MA Preferred
Other Locations- Gaithersburg, MD and Wilmington, DE
With one of the largest, most robust pipelines in the industry — including more than 120 research projects and product candidates. We are focused on three core therapeutic areas: Oncology; Respiratory, Inflammation and Autoimmune; and Cardiovascular and Metabolic Disease.
Oncology is one of the 5 key growth platforms for the company’s future success and we have an ambitious vision of delivering 6 new medicines to patients by 2020. Our strategy underpinning this vision is to target areas of unmet need, incorporate biomarker-driven patient selection, maximize value across tumor types and stages of disease, and focus on development of novel combinations.
We’re constantly pushing the boundaries of science to deliver life-changing medicines to patients, with a passion for discovery and a pipeline to show for it. We’re pioneering innovative research and exploring novel pathways across key therapeutic areas including oncology, respiratory, inflammation and autoimmunity, cardiovascular and metabolic disease, and infection and vaccines. And we’re industry-leading in immunology, protein engineering and translational science. We offer a unique and strong collaborative network as part of the AstraZeneca family, as together we explore synergies between small and large molecules.
We are seeking a well-trained clinician with strong leadership skills who is driven by science and the desire to develop novel Oncology drug therapies for cancer patients, and who has a mastery of the drug development process (especially early phase clinical trials), protocol writing & study conduct, data review and reconciliation, the principles of translational medicine, and what it takes to lead teams successfully.
Director/Senior Director, Clinical Development, Oncology will be based in Waltham, MA ( Gaithersburg, MD and Wilmington, DE) and will report to the Vice President, Clinical Development. Other responsibilities include;
- Leading a team of Clinical Development professionals responsible for delivering against Oncology Drug Development projects.
- Full responsibility for the planning, implementation and daily operation of a drug development projects,
- Collaborate with key internal and external stakeholders.
- Contribute to and support Department/Clinical initiatives to improve the quality and content of all clinical programs as well as the cross functional/organization processes designed to effectively deliver our R&D portfolio.
- Specific duties and major responsibilities include:
- Direct/Oversee the design and implementation of early stage clinical projects, as a member of our Product Development Team (PDT) and leader of the Clinical Sub-Team (CST). Ensure that the overall scientific and medical content of all clinical programs is scientifically and clinically rigorous.
- Prepare clinical development plans that integrate pre-clinical and early clinical findings while working to ensure cross-functional alignment on an ongoing basis throughout the early phases of clinical development.
- Design scientifically rigorous and maximally cost-effective clinical protocols that are aligned with the clinical development plan.
- Present and defend protocols and clinical development plans at internal governance forums.
- Serve as Medical Monitor, responsible for the safety monitoring of clinical trials, and as medical expert for Phase I/II studies, managing the process from protocol development thorough individual study report and integrated regulatory documentation. Collaboration with clinical operations
- Provide oversight and guidance to clinical team activities at the Product Development Team, Clinical Study Team, Clinical Trial Team, and Translational Science Sub-Team.
- Monitor study progress, ensure proper study conduct and adherence to the protocol, lead data review, evaluation, and analyses with support from Data Management and Stats & Programming team.
- Present study updates, interim results, and final headline data to senior management as required.
- Prepare various official and regulatory documents for Regulatory and other agencies, such as Dossiers, BLAs, INDs, Safety and Annual reports, handling of responses to regulatory agencies regarding questions about complex clinical development issues (e.g., safety or efficacy).
- Ensure that Serious Adverse Events are properly reported on a global basis.
- Lead cross-functional teams comprised of multidisciplinary professionals and clinical scientists. Direct responsibility for leading a team of Clinical Development professionals and ensure delivery of their portfolio of assets.
- Implement clinical R&D policies, SOPs and related directives.
- Review potential in-licensing candidates and present recommendations to Senior Management groups.
- Support any needed due diligence and prepare/present medically sound strategy and plans associated with advanced opportunities.
- Contribute and support Department/Clinical initiatives to improve the quality and content of all clinical programs as well as the cross functional/organization processes designed to effectively deliver our R&D portfolio.
- MD with a valid medical license required
- Medical specialty and sub-specialty training and certification are required in Oncology.
- Clinical or research experience (in an academic, pharmaceutical or CRO environment) related to the design and/or conduct of clinical studies in oncology and/or hematology is required.
- Senior Director- At least 5 years of experience in clinical research and/or Oncology drug development in pharmaceutical or CRO environment.
Next Steps – Apply today!
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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.