Associate Director (Patient Safety Scientist)

Associate Director (Patient Safety Scientist)

Introduction to role

This is an opportunity to further develop your pharmacovigilance (PV) experience in safety programs, 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.

We are looking for an experienced Associate Director, Patient Safety (PS) Scientist to join our Patient Safety department, working in 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, including coaching junior colleagues. You will play a leading role in delivering the safety strategy and requirements for your assigned drug project(s). Your ability to work collaboratively will facilitate cross-functional interactions with colleagues from across AstraZeneca and externally, including counterparts within Clinical Project Teams, Global Regulatory Affairs, and Global Commercial teams.

Accountabilities

As an Associate Director, PS Scientist, you will provide leadership in aggregating, reviewing, analyzing and interpreting safety-related data to generate information to support safety decision-making by prescribers, patients and payers, with the ultimate goal of protecting patients. You will apply your strong PV, oncology and scientific experience, knowledge and skills to lead in all aspects of safety documentation, including authoring and/or providing strategic safety input to regulatory documents, e.g., regulatory reports, health authority responses and the safety content of marketing authorization applications.

Essential Skills/Experience

• Bachelor’s degree in sciences/pharmacy/nursing degree or related field with 2+ years of relevant experience

• Patient Safety and/or Clinical/Drug Development experience working in or leading safety and/or scientific activities in at least 3 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

• Strong knowledge of PV regulations

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

• Ability to work effectively in an advanced matrix structure

Desirable Skills/Experience

• An advanced degree such as a MSc, PhD, or PharmD in a scientific discipline is preferred

• Advanced understanding of epidemiology

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

At AstraZeneca, we follow the science and pioneer new frontiers. Join our team dedicated to Oncology with an ambition to eliminate cancer as a cause of death. With multiple indications and high-quality molecules at all stages of our innovative pipeline, we keep pushing forward. Fusing cutting-edge science with the latest technology to achieve breakthroughs. Backed by investment, we aim to deliver 6 new molecular entities by 2025. A place built on courage, curiosity, and collaboration where bold decisions are driven by patient outcomes. Empowered to lead at every level, free to ask questions and take smart risks that write the next chapter for our pipeline and Oncology team.

Ready to make a difference? Apply today!

The annual base pay (or hourly rate of compensation) for this position ranges from $122,924 to $184,386. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.