Cell Tech Jobs in Reston, VA (NOW HIRING)

As aGlobal Safety Program Lead - Cell Therapy Oncology & Onco-Hematology, you will report to theGlobal Safety Head (GSH) of the Cell therapy Patient Safety Unit (CTPSU). You will be a senior leader within the CTPSU and play a key role bringing deep clinical understanding and judgement in benefit risk assessments for AstraZeneca cell therapies in oncology,specifically, but not limited to, the AZD0120 DURGA program in Multiple Myeloma. You will also have a role in shaping the culture of the department and will act as a coach and mentor to more junior Patient Safety staff. You will ensure processes adhere to Good Clinical and Pharmacovigilance Practice and regulatory requirements as well as AZ processes.

Accountabilities

In this role, you are accountable to the Global Safety Head, Cell Therapy,for theendtoendsafety strategy, delivery, and oversight ofAZD0120 Multiple Myelomaprogram, and potentially otherassets,acrosspreclinical, clinical, andpostmarketing. You will:

• Lead the Safety Strategy & Management Team (SSaMT) and Safety Surveillance Team for assigned asset(s), setting safety goals aligned to therapeutic area and product strategy, and ensuringhighquality, compliant delivery of safety activities.

• Own the scientific and clinical safety content for the asset(s), including safety TPP, safety Go/NoGocriteria, toxicity management guidelines, and safety messaging, integrating inputs from clinical, epidemiology,preclinical, and literature.

• Represent Global Patient Safety at key governance and external forums (e.g., DRC,eCRC, SARB, FSIRB, DSMB/DMC, MARC, CPT, GPT, Advisory Boards) in partnership with the Global Safety Head; lead responses to complex technical safety issues.

• Ensure the quality, compliance, andtimelydelivery of safety documents (e.g., RMPs, PSURs/PSRs) and safety contributions to study design, protocol concepts, regulatory submissions, HA/EC queries, and labeling for global markets.

• Provide strategic safety leadership to safety medical directors and scientists, guiding study and program execution, data monitoring and interpretation, signal management, andpostmarketingsurveillance to inform labeling and risk minimization.

• Build andmaintainstrong internal and external networks, including alliance partners, to drive proactive,crossfunctional,solutionorientedsafety actions; may support due diligence andinlicensingassessments.

• Ensuring expert input to safety-relevant elements of study design and interpretation, including efficient use of digital/ artificial intelligence (AI) tools andmethodology(e.g.adverse eventvisualisationand disproportionality analysis).

• Linemanageanddevelopa team of safety physicians and/or scientists;embednew processes, systems, and ways of working; prioritize risk mitigation and effective issue resolution;operateto the highest ethical, quality,GxP, and AZ standards.

Essential for the role

• Medical degree or equivalent degree in biomedicine or science, with extensive clinical safety/pharmacovigilance experience.

• Strong relevant experience in clinical safety and risk management across pharma/biotech/CRO/academia/Health Authorities, spanning preandpostlaunch.

• Proventrack recordof leading asset safety strategy and delivery, withdemonstratedstrategic influence on clinical studies/programs and benefit-risk decisions.

• Deep knowledge of global PV regulations, standards, and safety deliverables (e.g., RMPs, PSURs/PSRs), and experience contributing to global regulatory submissions and interactions with major agencies.

• Strong matrix leadership and influencing skills withcrossfunctionalleaders (e.g., Clinical Development, Medical Affairs, Regulatory Affairs), including representation at senior governance.

• Demonstratedpeopleleadership: ability to lead, coach, and mentor safety physicians/scientists; excellent communication skills with the ability to present complex topics to senior leaders.

• Ability to travel domestically and internationally, as business needs require.

Desirable for the role

• PhD or other advanceddegreein a relevant scientific discipline.

• Research experience in the GCT field.

• Medical specialty, or documented training, in oncology and/or haemato-oncology.

• Basic and/or Translational Research background, including authoring peer reviewed publications.

• Goodknowledge of PV regulationsin China, Australia, Japan, rest of Asia.

• Recognizedsubjectmatterexpertiseand sound independent judgment in clinical safety; disease area safety leadership experience.

• Experience speaking at industry conferences and shaping external safety messaging.

• Experience supportinginlicensing/due diligence from a safety perspective.

• Proven ability to embed new processes/systems and drive continuous improvement in safety ways of working.

The annual base pay (or hourly rate of compensation) for this position ranges from $288,059.20 - $432,088.80USD. 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.