Director, Principal Patient Safety Scientist

Job Title: Director Principal Patient Safety Scientist

Location: Gaithersburg MD

At AstraZeneca, we deliver life-changing medicines to millions of people globally. Our purpose is ambitious and so is our approach. Crafting a more agile and inclusive environment means building an inspiring culture where we celebrate innovative thinking. Our strategy and ability to transform our medicines portfolio means we have a drug-development pipeline that presents incredible opportunities to push the boundaries of science. Faced with complex disease challenges, we focus on outstanding performance to drive the world’s best and most progressive drug development programs.

Our team is looking for a Director, Principal Patient Safety (PS) Scientist to lead the strategy for proactive PV and risk management planning of multiple complex products within the Oncology Therapeutic Area. In this exciting and challenging role, you will work collaboratively with the Global Safety Physician (GSP) and other PV Scientists and physicians to shape the culture of the safety team and the wider PSTA function. You will facilitate collaboration with colleagues from across AstraZeneca and externally, including counterparts within Clinical Project Teams, Global Regulatory Affairs, and Global Commercial teams.

This opportunity will further develop your pharmacovigilance (PV) expertise in safety program, spanning the entire life cycle of drug development and peri-/post-submission. Our Scientists and Physicians play a strategic role in developing our medicines and the safety science of the program. AstraZeneca’s oncology pipeline, which includes novel combinations and modalities, provides an intellectual challenge to the safety teams requiring a broad portfolio and scientific management approach to projects. Our teams’ experience develops as our portfolio does.

Patient Safety sits within the Chief Medical Office, where we have a crucial role to play. This is an exciting period for us, as well as for those poised to join us!

Main Responsibilities:

• Provide subject matter expertise and leadership in the therapeutic area and across products.

• Lead the safety surveillance strategy and the presentation of sophisticated safety issues to cross-functional teams and governance committees as well as periodic safety reports and health authority responses.

• Partner with the GSP and other functional specialists to lead the safety strategy for regulatory submissions of new products, formulations or indications (NDA/BLA, MAA).

• Participate in due diligence activities, negotiating the PV components of contracts/ agreements with third parties to ensure quality and integrity of these documents.

• Provide training and mentorship to other PV Scientists and junior physicians.

Minimum Requirements:

• BS in sciences/pharmacy/nursing or related field

• 7+ years of relevant experience

• Advanced Patient Safety and/or Clinical/Drug Development experience of leading safety &/or scientific activities, across at least 4 of the following areas:

  • Clinical drug development (Early and/or Late Phase: develop program level safety strategy, including proactive risk identification & mitigation planning)

  • Post-Marketing Surveillance (including signal detection & evaluation)

  • MAA/BLA submissions (setting strategy; preparation and authoring of the safety related aspects of the Common Technical Document)

  • Periodic Safety Reports (establish and lead strategy, preparation and authoring)

  • Risk Management Plans (establish and lead strategy, preparation and authoring)

• Governance board interactions and communication across a range of activities

• Advanced knowledge of PV regulations

• Demonstrated ability to handle more than one complex project simultaneously, prioritizing well and recognizing key issues

• Ability to work effectively in an advanced matrix structure

• Proficient in written and verbal English

Desirable

• MS or PhD in relevant scientific field preferred

• 5 additional years of proven experience

• Strong network and reputation within the business and industry

• Extensive knowledge of the latest technical and regulatory expectations

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