Director, Clinical Pharmacology & Quantitative Pharmacology (CPQP)- Oncology

AstraZeneca•Gaithersburg, MD

8d•Hybrid

About The Position

At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person. Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our Gaithersburg office 3 days a week. Our head office is purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects. Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we’re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention. This is a strategic and scientific job accountable for providing the scientific quality of clinical pharmacology program performed within Oncology. This person will apply state of the art Clinical Pharmacology and Model-Informed Drug Development (MIDD) approaches to influence designs and internal/external decision making across the portfolio. The individual will closely with Oncology TA lead and discipline lead to provide strategic and technical advice, support global initiatives to develop the clinical pharmacology discipline and serve as a global reviewer and mentor to junior staff. The incumbent will work closely with colleagues across Innovative Medicines, Global Medicines Development and other AZ units to ensure implementation of clinical pharmacology/ MIDD and to drive a QCP program across the business.

Requirements

Expert knowledge of pharmacokinetics and Model-Informed Drug Development (T)
Demonstrated broad translational and clinical development expertise and experience exemplified by at least 10 years international drug development experience, with emphasis on Clinical Pharmacology
PhD degree preferred or equivalent (M.Sc./Pharm.D. as minimum requirement) with relevant experience required
International scientific reputation gained from scientific publishing in the field on DMPK/Clin Pharm/MIDD (T,D,L)
Demonstrated ability to identify, develop and execute clinical pharmacology activities at level of portfolio (S)
Excellent oral and written communication skills
A demonstrated knowledge of global regulatory, compliance, processes, standards and issues specific to clinical pharmacology (T)
Strong leadership capabilities, in particular with regards to influencing skills (L)
Experience in mentoring and developing others (L)
Training and experience with PK software (Phoenix, WinNonlin)

Nice To Haves

Experience in several organisations
Early and late phase clinical development experience including regulatory filing (NDA, MAA)
Experience with relevant software and tools within the field of MBDD (e.g. SIMCYP, R, NONMEM) (T)
Experience working on ADCs and Radio conjugates

Responsibilities

Accountable for developing a culture supportive of MIDD approaches within the Oncology influencing key partners, stakeholders and regulators of its value and application (L)
Accountable for planning and executing state-of-the-art clinical pharmacology approaches with direct value for projects cross the portfolio including go/no go decision making (T)
Scientific and strategic input into pre-clinical, clinical, and post-approval development plans (S, T)
Accountable for oversight, support and delivery of scientific and strategic clinical pharmacology plans related to Oncology in both early and late development (S, T, D, L)
Support evaluation of candidates for in/out-licensing (S, T, D, L)
Contribution to the identification and development of drug-disease models and other modelling approaches to support internal and external decision making in collaboration with internal and external partners (when relevant) (S,D, L)
Support the Oncology and Discipline lead in development of strategy, in scientific operations and business management (S, T, L)
Accountable to provide peer review and mentoring within and across TA’s (S, T, L)
Support and contribute to the development of the Clinical Pharmacology Discipline in terms of providing training and knowledge sharing (S, T, D, L)
Monitoring external and internal environment in terms of relevant new methodologies and applications (T, D)
Increase AZ profile externally in the area of clinical pharmacology/MIDD by speaking at external events and by publication in recognized external journals (L)
Ensure AZ clinical pharmacology plans are aligned with current regulatory expectation (T)