Medical Director, Senior Patient Safety Physician, Cell Therapy - Oncology

AstraZeneca•Gaithersburg, MD

72d

About The Position

Do you have expertise in, and passion for Patient Safety in Oncology or Haemato-Oncology? Would you like to apply your expertise to provide medico-scientific and clinical strategic leadership in a company that follows the science and turns ideas into innovative life changing medicines? Then AstraZeneca might be the one for you! 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 a Medical Director, Senior Patient Safety Physician, Cell Therapy Oncology, you will report to the Cell Therapy Oncology Global Safety Project Lead (GSPL). You will be a senior leader within the Cell Therapy Patient Safety Unit (CTPSU) and play a key role bringing deep clinical understanding and judgement in benefit risk assessments for AstraZeneca cell therapies in oncology and/or haemato-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.
3+ years of proven clinical experience as a physician or academic clinician.
Extensive experience in pharmacovigilance, with clear evidence of delivering to a high standard. Understanding of the medico-legal aspects of pharmacovigilance.
Detailed 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.
Documentable strategic leadership expertise is Patient Safety of complex drug programs
Ability to collaborate across a matrixed environment and influence cross-functional leaders on decision-making.
Demonstrated ability to influence key business partners within and outside of company
Proficiency with both written and verbal communications

Nice To Haves

Research experience in the GCT field
Medical specialty, or documented training, in oncology or haemato-oncology
5+ years of proven clinical experience
Oncology therapeutic area expertise and commercial understanding
Extensive general medical knowledge
Able to work across therapeutic areas (TAs) and functions
Experienced in using AI tools
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 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 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 safety signal validation.
Ensuring expert input to 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 safety 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 Safety-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.

Benefits

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)
commission payment eligibility (sales roles)
qualified retirement program [401(k) plan]
paid vacation and holidays
paid leaves
health benefits including medical, prescription drug, dental, and vision coverage

Stand Out From the Crowd

Upload your resume and get instant feedback on how well it matches this job.

Upload and Match Resume