If you're inspired by the possibilities of science to change lives and you thrive when making brave decisions - join us.
MedImmune is the worldwide biologics research and development arm of AstraZeneca. Here, you'll have the opportunity to make a difference in people's lives every day. As one of the world's premier biotechnology companies, our mission is centered on delivering life-changing products that advance world health, and help fight and cure disease. As a Senior Director, Clinical Development, Immuno-Oncology in Gaithersburg, MD, you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives.
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.
MedImmune has a dynamic environment that fosters collaboration and innovation. We attract top minds, and we nurture and build top talent.
Main Duties and Responsibilities
We are seeking a well-trained clinician with strong management experience who is driven by science and the desire to develop novel Immuno-Oncology therapies for cancer patients to lead a team of Clinical Development professionals (including MDs and clinical scientists) responsible for delivering against Immuno-Oncology Drug Development projects. You will have the opportunity for growth and development while working in a vibrant environment and "biotech" culture.
You will have full responsibility for the planning, implementation and daily operations for drug development projects, including those with a focus on T-Cells, innate immunity, and tumor microenvironment. In addition, you will 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.
•Design and oversee implementation of early stage clinical projects (as a member of our Product Development Team (PDT) and leader of the Clinical Sub-Team (CST)).
•Prepare clinical development plans that integrate pre-clinical and early clinical findings to ensure cross-functional alignment throughout the early phases of clinical development.
•Design scientifically/ clinically 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, study execution (e.g., ensuring that Serious Adverse Events are properly reported on a global basis) thorough individual study report and integrated regulatory documentation.
•Provide oversight and guidance for Product Development Team, Clinical Study Team, Clinical Trial Team, and Translational Science Sub-Team.
•Present study updates with protocol adherence, interim results, and final headline data to senior management as required (with support from Data Management and Stats & Programming team).
•Prepare 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).
•Lead cross-functional teams comprised of multidisciplinary professionals and clinical scientists with direct responsibility for leading the Clinical Development team and effective delivery of their assets.
•Implement clinical R&D policies, SOPs and related directives.
•Review potential in-licensing candidates and present recommendations to Senior Management groups.
•Medical Doctor with specialty training and certification in Oncology with a valid medical license
•The ideal candidate will have a mastery of the drug development process in oncology, ideally immuno-oncology (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.
•At least 5 plus years' experience in Oncology clinical research in the pharmaceutical industry related to the design and/or conduct of clinical studies in oncology and/or hematology
•Excellent oral and written communication skills; strong interpersonal and listening skills
•Results driven and able to achieve creative and sound outcomes
•Proven leadership skills and demonstrated ability to interact collaboratively in a cross-functional environment
•Ability to make sound and timely decisions; agile in learning and action oriented
•High level of emotional intelligence; able to deal with ambiguity
•Able to relate to varied level audiences across organization; able to build and lead effective teams and coach & develop team members; able to set priorities for team and maintain accountability; skilful in negotiating organizational boundaries and hierarchy; experience managing and developing others
•Able to balance scientific & business perspectives; able to delegate effectively; strategic thinker who can provide vision and purpose for teams; demonstrates managerial courage
•Immuno-therapy experience. Specifically, experience in developing an immuno-oncology drug from translational/pre-clinical through PoC; experience in late-stage oncology drug development and/or registration
•Leadership and direct managerial experience in leading small teams across multiple phases of oncology drug development
Next Steps - Apply today!
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience - it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.