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Lieu: Gaithersburg, Maryland, États-Unis
ID de l'offre 12069535
Date de publication: 08/01/2019

Job Profile – Sr. Director Early Clinical Development Physician

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.  Our emphasis is on immuno-oncology and antibody drug conjugates (ADCs).

If you’re inspired by the possibilities of science to change lives and you thrive when making brave decisions – join us. Here at AstraZeneca, 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. 

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.

AstraZeneca has a dynamic environment that fosters collaboration and innovation. We attract top minds, and we nurture and build top talent.

Position Summary:

We are seeking a well-trained clinician with strong leadership skills who is driven by science and the desire to develop novel Immuno-Oncology 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.   This individual will have the opportunity for growth and development while working in a vibrant environment and “biotech” culture.

Senior Director, Clinical Development, Oncology will be based in Gaithersburg, Maryland and will report to the Vice President, Early Clinical Development, Oncology R&D.

Responsibilities include:

·         Leading a team of Clinical Development professionals responsible for delivering against Immuno-Oncology Drug Development projects.

·         Full responsibility for the planning, implementation and daily operation of a drug development projects, including a focus in the ACT and T-Cells.

·         Collaborate with key internal and external stakeholders and may serve as the project Medical Monitor.

·         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.

·         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.

Educational Requirements:

·         MD with a valid medical license required

·         Medical specialty and sub-specialty training and certification are required in Oncology.

Experience:

·         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.

·         Immuno-therapy experience preferred.  Areas of concentration should include ACT/T-Cell experience desirable.

·         Senior Director- At least 5 plus years’ experience in clinical research and/or Oncology drug development in pharmaceutical or CRO environment.

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.

Senior Director, Early Clinical Development ORD - PI
Développement clinique

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