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AstraZeneca

Global pharmaceutical company developing prescription medicines

Global Safety Program Lead

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeGaithersburg, MD, USA

About the Job

Requirements

  • A medical degree or equivalent degree in biomedicine or science is required.
  • At least 5 years of extensive relevant clinical, safety, and risk management experience in the pharmaceutical, biotechnology, contract research organization industry, academia, or health authorities is required.
  • A proven track record of successful clinical safety delivery, with demonstrated examples of strategic influence on clinical studies or programs, is required.
  • The candidate must be able to collaborate across a matrixed environment and influence cross-functional leaders in decision-making, including Clinical Development, Medical Affairs, and Regulatory Affairs.
  • Thorough global knowledge and understanding of pharmacovigilance and safety deliverables, standards, and processes, including pre-launch and post-launch experience, is required.
  • Experience with global regulatory submissions and interaction with major regulatory agencies is required.
  • The candidate must be able to lead, coach, and mentor other safety medical directors and scientists.
  • Availability to travel domestically and internationally is required.
  • The candidate must be able to present complex topics to senior leaders at safety and development governance meetings for alignment and endorsement.

Responsibilities

  • The role is accountable to the Global Safety Head for safety strategy, delivery, and oversight of assigned assets, working with safety physicians and scientists responsible for developing, implementing, and applying safety strategy at asset and study level.
  • The role generates strategic opportunity and value for assigned assets or indications to optimize benefit-risk and maintain competitive advantage, and may deputize for the Global Safety Head.
  • The role is accountable for overall scientific and clinical safety content for assigned assets or indications.
  • The role ensures implementation and high-quality delivery of the Safety & Strategy Management Team and Safety Surveillance Team for assigned assets.
  • The role is responsible for overall safety content for products or indications aligned to GPT strategy and sets safety team goals aligned to therapeutic area and product strategy.
  • For assigned assets, the role is accountable for the safety target product profile, Safety Go/No Go criteria, safety communication and messaging, and toxicity management guidelines.
  • The role represents Global Patient Safety at governance and other safety-related forums, including DRC, eCRC, SARB, FSIRB, DSMB/DMC, Medical Affairs Review Committees, product teams such as CPT and GPT, and Advisory Board meetings in partnership with the Global Safety Head.
  • The role is accountable for the quality of key safety deliverables, including Risk Management Plans and Periodic Safety Reports, and for compliance with pharmacovigilance regulations for assigned assets.
  • The role leads responses to complex technical issues for specific safety aspects of assigned assets.
  • The role is accountable for safety contributions to study designs and delivery of study concepts within assigned programs.
  • The role provides strategic safety knowledge and support to safety medical directors and scientists through initiation, execution, and completion of clinical programs, using an integrated understanding of product strategy.
  • The role leads safety physicians and scientists in safety strategy and input to program design, monitoring, and interpretation of data from preclinical and clinical studies, communications, post-marketing surveillance, epidemiology, and literature for each asset.
  • The role ensures that the team's work complies with Safety, Health and Environment standards and relevant internal and external regulations and standards.
  • The role represents the company and is accountable for the quality of safety delivery, including regulatory submissions and responses to health authority queries, ethics committees, marketing companies, and investigators or sites; it provides clarifications and resolves safety issues in study teams.
  • The role may support in-licensing opportunities.
  • The role promotes and enables cross-functional, proactive, solutions-oriented team actions and behaviors.
  • The role is accountable for implementing new processes, systems, learning, and ways of working.
  • The role prioritizes risk mitigation strategies and effective troubleshooting.
  • The role line-manages a team of safety physicians and/or scientists.
  • The role maintains current knowledge of relevant safety scientific literature and clearly communicates impactful information.
  • The role is accountable for proper data collection and interpretation to determine risks and inform product labeling in global markets.
  • The role delivers balanced, statistically robust analyses of clinical safety data to drive interpretations and develop novel proposals.
  • The role serves as a source of scientific and clinical safety knowledge for the Product Team in analyzing and interpreting scientific and clinical safety data.
  • The role maintains awareness of new and emerging clinical safety developments globally.
  • The role maintains global networks and works with international colleagues and external alliance partners on safety initiatives and regulatory issues.
  • When required, the role provides safety guidance for investigator-initiated trials in cooperation with regional marketing companies.
  • The role may perform other job-related duties as assigned.

About the Company

AstraZeneca

Global pharmaceutical company developing prescription medicines

AstraZeneca develops and markets prescription medicines and vaccines worldwide, with a focus on oncology, cardiovascular/metabolic, respiratory, and infectious diseases. Its products work by targeting specific biological pathways or cells, using small-molecule therapies, biologics, and vaccines to treat diseases or prevent infections. It differentiates itself through its dual heritage from Sweden and the UK, a broad pipeline, and strong R&D and collaborations that move from discovery to patient access. Its goal is to improve people’s health by discovering, developing, and delivering medicines and vaccines to patients worldwide.

Company size
10,001+
Company stage
IPO
Headquarters
Cambridge, United Kingdom
Founded
1913

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