At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe. As an Associate Director (Career Level E)/Director (Career Level F), Clinical Pharmacology in Waltham, MA, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives. IMED (Innovative Medicines and Early Development) focuses on scientific advances in small molecules, oligonucleotides and other emerging technologies and drug discovery platforms across our focus areas.
AstraZeneca’s vision in Oncology is to help patients by redefining the cancer-treatment paradigm, with the aim of bringing six new cancer medicines to patients between 2013 and 2020. A broad pipeline of next-generation medicines is focused principally on four disease areas - breast, ovarian, lung and hematological cancers. As well as other tumor types, these are being targeted through four key platforms - immunotherapy, the genetic drivers of cancer and resistance, DNA damage repair, and antibody drug conjugates, underpinned by personalized healthcare and biomarker technologies.
Main Duties and Responsibilities
You will define a fit-for-purpose program to understand the Clinical Pharmacology aspects of the drugs and to meet regulatory requirements, consistent with the projects milestones and timelines across all phase in development. You will be accountable for Clinical Pharmacology input to Study Designs/Protocols for studies as part of development program, and be accountable for the design and delivery of clinical pharmacology studies to late phase projects and acts as the Quantitative Clinical Pharmacology interface with the projects organization.
You will integrate the Clinical Pharmacology knowledge and ensure that it meets all relevant regulatory standards to support the appropriate use of the drug in the target population. You will evaluate and interpret Clinical Pharmacology data to prepare for internal governance bodies, interpret and prepare the Clinical Pharmacology part of project and regulatory documents (e.g. IND, IMPD, IB, NDA CTD), defend the clinical pharmacology package in interactions with Regulatory Authorities, and represent the discipline in Due Diligence and in-licensing activities.
Finally, you will be jointly accountable with the pharmacometrician for providing a scientific justification for the dose selection, provide scientific training in Clinical Pharmacokinetics and clinical pharmacology and support internal review processes, collaborate with Pharmacometricians in the modeling of emerging PK/PD data, publish scientific papers describing the PK and clinical pharmacology of their project, communicate Clinical Pharmacology perspective, results and implications to teams: Innovative Medicines (iMED) and Global Medicines Development (GMD), and work collaboratively with the iMed DMPK Functional Project Leaders (DPL) to ensure an adequate forward and back translation of Clinical PK/ADME data.
- PhD degree preferred or equivalent (M.Sc./Pharm.D.) with relevant experience required
- Broad background and a comprehensive understanding of Clinical Pharmacology aspects of drug development
- Significant experience in pharmaceutical R&D with at least three years’ of drug development experience for the Associate Director level and seven years’ experience for the Director level
- Expert knowledge of pharmacokinetics and Model-Based Drug Development
- Expert knowledge of drug absorption, metabolism and disposition
- Biological understanding of drug absorption and disposition
- Excellent oral and written communication skills
- Demonstration of significant international drug regulatory experience
- External scientific expertise demonstrated by scientific publishing in the field of clinical pharmacology
- Early and late phase clinical development experience
- Experience in Oncology
- Experience with small molecules, biologics, or other therapeutic modalities (e.g. antibody drug conjugates oligonucleotides, etc.)
Next Steps -- Apply today!
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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