Global Safety Program Lead/Sr Medical Director

AstraZeneca • Boston, MA

28d

About The Position

This is what you will do: The Global Safety Program Lead, Senior Director is accountable to the Global Safety Head for the safety strategy, delivery, and oversight of the assigned asset(s); the professional will work with safety physicians and scientists responsible for the development, implementation, and application of safety strategy at asset and study level. Acts strategically to generate opportunity and value for the asset or indication to optimize benefit risk and maintain a competitive advantage. Line manages a team of safety physicians and / or scientists. They will be required at times to deputise for the Global Safety Head. The Global Safety Program Lead, Senior Director will operate according to the highest ethical, quality and compliance standards in compliance as provided by global and local regulations, GxP practice and AZ procedures. You will be responsible for: Safety Expert Accountable for the overall scientific and clinical safety content for the assigned asset(s) or indications. Accountable for the implementation and the high quality delivery of the Safety & Strategy Management Team (SSaMT) and Safety Surveillance Team for assigned asset(s). Responsible for overall safety content for the product or indication(s) aligned to GPT strategy. Sets safety team goals aligned to TA and product strategy. For the assigned asset(s), accountable for safety TPP, Safety Go/No Go criteria, safety communication/messaging and the guidelines for toxicity management of the asset Is accountable for project representation for Global Patient Safety at governance and other forums where safety is involved, eg DRC, eCRC, SARB, FSIRB, and DSMB/DMC, Medical Affairs Review Committees (MARC), product teams such CPT and GPT and Advisory Board meetings in partnership with GSH. Accountable for the quality of key safety deliverables e.g., Risk Management Plans (RMPs) and Periodic Safety Reports (PSRs), compliance and adherence to PV regulations of the assigned asset(s). Leads response to complex technical issues for specific safety aspects for the assigned asset(s). Is accountable for safety contribution to study designs and study concept delivery within their assigned program Through integrated understanding of the product strategy, provides strategic safety knowledge and support to the safety medical directors and scientists through initiation, execution, and completion of the clinical programs for the assigned asset(s). Leads the safety physicians and scientists to support the safety strategy and input into the program design, monitoring, and data interpretation from pre-clinical and clinical studies, communication and post-marketing surveillance, epidemiology, pre-clinical and literature, epidemiology for each asset. Ensures that own work and work of team is compliant with Safety Health and Environment (SHE) standards and all other relevant internal and external regulations and standards. Represents the Company and accountable for the quality of safety delivery e.g., regulatory submissions, answers to Health Authority Queries, Ethic Committees, Marketing Companies, investigators/sites, and provides clarifications as well as solves safety issues in the study team. May be required to support in-licensing opportunities. Promotes and enables cross-functional, proactive and solutions-orientated team actions and behaviours Accountable for implementation of new processes, systems and learning, including new ways of working. Prioritizes risk mitigation strategies and effective trouble shooting. Line manages a team of safety physicians and / or scientists. Scientific clinical safety analytical accountabilities Maintains up-to-date knowledge of the relevant safety scientific literature, and is able to clearly communicate key impactful information, Accountable for proper data collection and interpretation for determination of the risks and inform the label in markets globally Delivers analyses of clinical safety data in a balanced and statistically robust manner, to drive interpretations and develop novel proposals. Serves as a source of scientific and clinical safety knowledge for the Product Team, in the analyses and interpretation of scientific and clinical safety data.

Requirements

• Medical degree or equivalent degree in biomedicine or science
• 5 years extensive relevant clinical, safety and risk management experience in the pharmaceutical, biotech, CRO industry, academia or Health Authorities
• Proven track record of successful clinical safety delivery with demonstrated examples of strategic influence to clinical studies/programs.
• Ability to collaborate across a matrixed environment and influence cross-functional- leaders on decision-making (e.g. Clinical Development, Medical Affairs, Regulatory Affairs).
• Thorough knowledge and understanding of pharmacovigilance & safety deliverables, standards and processes at a global level; including pre and post launch experience.
• Experience of global regulatory submissions and interacting with major regulatory agencies.
• Demonstrated ability to successfully lead, coach, and mentor other safety medical directors/scientists.
• Available to travel domestically and internationally
• Demonstrated ability to present complex topics to senior leaders at safety and development governances for alignment and endorsement.

Nice To Haves

• PhD (or other complementary degree) in scientific discipline.
• Excellent, independent judgment based on leading-edge knowledge and expertise.
• Excellent speaking skills, industry conference speaking experience.
• Excellent, independent judgment based on knowledge and expertise.
• Demonstrated clinical safety and research expertise in an appropriate disease area.

Responsibilities

• Accountable for the overall scientific and clinical safety content for the assigned asset(s) or indications.
• Accountable for the implementation and the high quality delivery of the Safety & Strategy Management Team (SSaMT) and Safety Surveillance Team for assigned asset(s).
• Responsible for overall safety content for the product or indication(s) aligned to GPT strategy.
• Sets safety team goals aligned to TA and product strategy.
• For the assigned asset(s), accountable for safety TPP, Safety Go/No Go criteria, safety communication/messaging and the guidelines for toxicity management of the asset
• Is accountable for project representation for Global Patient Safety at governance and other forums where safety is involved, eg DRC, eCRC, SARB, FSIRB, and DSMB/DMC, Medical Affairs Review Committees (MARC), product teams such CPT and GPT and Advisory Board meetings in partnership with GSH.
• Accountable for the quality of key safety deliverables e.g., Risk Management Plans (RMPs) and Periodic Safety Reports (PSRs), compliance and adherence to PV regulations of the assigned asset(s).
• Leads response to complex technical issues for specific safety aspects for the assigned asset(s).
• Is accountable for safety contribution to study designs and study concept delivery within their assigned program
• Through integrated understanding of the product strategy, provides strategic safety knowledge and support to the safety medical directors and scientists through initiation, execution, and completion of the clinical programs for the assigned asset(s).
• Leads the safety physicians and scientists to support the safety strategy and input into the program design, monitoring, and data interpretation from pre-clinical and clinical studies, communication and post-marketing surveillance, epidemiology, pre-clinical and literature, epidemiology for each asset.
• Ensures that own work and work of team is compliant with Safety Health and Environment (SHE) standards and all other relevant internal and external regulations and standards.
• Represents the Company and accountable for the quality of safety delivery e.g., regulatory submissions, answers to Health Authority Queries, Ethic Committees, Marketing Companies, investigators/sites, and provides clarifications as well as solves safety issues in the study team.
• May be required to support in-licensing opportunities.
• Promotes and enables cross-functional, proactive and solutions-orientated team actions and behaviours
• Accountable for implementation of new processes, systems and learning, including new ways of working.
• Prioritizes risk mitigation strategies and effective trouble shooting.
• Line manages a team of safety physicians and / or scientists.
• Maintains up-to-date knowledge of the relevant safety scientific literature, and is able to clearly communicate key impactful information,
• Accountable for proper data collection and interpretation for determination of the risks and inform the label in markets globally
• Delivers analyses of clinical safety data in a balanced and statistically robust manner, to drive interpretations and develop novel proposals.
• Serves as a source of scientific and clinical safety knowledge for the Product Team, in the analyses and interpretation of scientific and clinical safety data.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees