Associate Medical Director, Patient Safety Physician, Cell Therapy – Long-Term Follow-Up (LTFU)

AstraZeneca•Gaithersburg, MD

68d

About The Position

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases. We are more than one of the world’s leading pharmaceutical companies. Working with one of the broadest cell therapy pipelines in the industry offers the possibility to advance the most novel Cell and Gene Therapy (CGT) technologies at all development stages across multiple indications. It takes each of us to challenge our thinking to keep pushing our pipeline forward and shape the future of cell and gene therapies. As an Associate Medical Director, Patient Safety Physician, Cell Therapy Long-Term Follow-Up (LTFU), you will be a leader within the Cell Therapy Patient Safety Unit (CTPSU) and play a key role bringing deep clinical understanding and judgement in long term benefit risk assessments for AstraZeneca cell therapies in oncology. 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.

Requirements

Medical Degree or equivalent.
Understanding of the medico-legal aspects of cell therapy LTFU.
Understanding of pharmaceutical safety, reporting, and surveillance processes with strong experience of Patient Safety related to clinical trials and marketed products in any relevant field such as Pharmaceutical Industry, Regulatory Agency, or Public Health agency.
Experience in designing, overseeing, and implementing clinical studies with a focus on patient safety, including adverse event monitoring, safety data review, signal detection and evaluation, and interpretation of trial results to inform benefit–risk assessments and safety labeling.
Capacity to collaborate across a matrixed environment and influence cross-functional leaders on decision-making.
Ability to influence key business partners within and outside of company.
Proficiency with both written and verbal communications.
Experienced in using AI tools.

Nice To Haves

Research experience in the GCT field.
Medical specialty, or documented training, in oncology, immunology, and/or rare diseases.
2+ years of proven clinical experience
Experience in pharmacovigilance, with evidence of delivering to a high standard.
Strategic leadership expertise in Cell Therapy Patient Safety.
Cross-therapeutic area (TA) expertise and commercial understanding.
Able to work across TAs and functions.
Basic and/or Translational Research background, including authoring peer reviewed publications.
Good knowledge of PV regulations in China, Australia, Japan, rest of Asia.

Responsibilities

Providing strategic Long Term Patient Safety input to CGT drug development programs as part of a global matrix team with high-quality contribution to Safety & Strategy Management Team (SSaMT) deliverables
Responsible for safety contribution to long-term follow-up (LTFU) study designs and study concept delivery within their assigned study/program
Collaboration with PS team members to undertake safety surveillance activities and prepare high quality evaluation documents to describe safety findings including LTFU safety signal validation.
Ensuring expert input to LTFU safety-relevant elements of study design and interpretation, including efficient use of digital/ artificial intelligence (AI) tools and methodology (e.g. adverse event visualisation and disproportionality analysis.
Providing leadership to support project discussions with governance boards, including interactions with Patient Safety Review Board.
Leading the cell therapy LTFU strategy for regulatory communication and provide oversight of higher-level documents to support submission activities for assigned studies/products.
Leading medico-scientific contributions to risk management plans (RMPs) for assigned products and to Periodic Reports, including PBRERs, DSURs.
Authoring and accountable for the LTFU-related aspects of the Target Product Profile (TPP) and internal Go/No-Go Investment Decisions (ID) for the CTG product throughout its lifecycle
More broadly you are expected to participate in advisory discussions to support other Patient Safety teams in the development of their safety strategy and may be asked to represent Patient Safety in cross-functional discussions with internal and external partners.
May be required to support in-licensing opportunities.