Associate Director, Patient Safety Scientist - Oncology R&D at AstraZeneca in Gaithersburg, Maryland

Job Description:

Job Title: Associate Director, Patient Safety Scientist




Location: Onsite 3 days in Gaithersburg MD




Would you like to use your drug safety or pharmacovigilance experience to make a difference to the lives of millions of patients across the world? If you would, please read on!



At AstraZeneca, we work together to deliver innovative medicines to patients across global boundaries. We make an impact and find solutions to challenges. We do this with integrity, even in the most difficult situations, because we are committed to doing the right thing.


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


As an Associate Director, PS Scientist, you will provide leadership in aggregating, reviewing, analysing 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 authorisation applications.


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. 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 to deliver life-changing medicines. Faced with complex disease challenges, we focus on exceptional performance to drive the best and most transformative drug development programmes ever.



Essential Requirements

• A Bachelor's in sciences/pharmacy/nursing degree or related field with relevant experience or an advance degree with relevant experience
  
  


• Patient Safety and/or Clinical/Drug Development experience working in or leading safety &/or scientific activities in at least 3 of the following areas:
  
  


• Clinical drug development (Early and/or Late Phase: develop programme 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
  
  


• Good 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
  
  

Preferred Requirements

• MSc/PhD/PharmD in scientific discipline
  
  


• Advanced understanding of epidemiology
  
  
  

The annual base pay 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.



In Office Requirement:



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.



So, what's next:



Are you already envisioning yourself joining our team? Good, because we can't wait to hear from you!



Why AstraZeneca?



At AstraZeneca's Oncology R&D business area, you'll be part of a team playing a critical role in driving meaningful change in the way we predict, prevent and treat patients' conditions. We're actively embracing and investing in technology, harnessing digital, data and analytics to reimagine the future of healthcare and deliver improved outcomes to patients beyond core medical. We're shaping the future, improving and speeding up portfolio development, improving the patient experience and outcomes at clinical trials. Join the team that is co-creating a digital ecosystem with patients at its core.


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 authorization and employment eligibility verification requirements. Apply Now