Talent.com
Global Safety Program Lead (Senior Director)

Global Safety Program Lead (Senior Director)

AstraZeneca GmbHBoston, Massachusetts, US
job_description.job_card.variable_days_ago
serp_jobs.job_preview.job_type
  • serp_jobs.job_card.full_time
job_description.job_card.job_description

This is what you will do :

You can get further details about the nature of this opening, and what is expected from applicants, by reading the below.

The individual is accountable to the Global Safety Head for the safety strategy, delivery, and oversight of the assigned asset(s); the role holder 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 deputize for the Global Safety Head. The individual 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 :

  • 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 behaviors
  • 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.

You will need to have :

  • 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[1]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.
  • We would prefer for you to have :

  • 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. AstraZeneca Job Profile
  • Ability to collaborate across a matrixed environment and influence cross-functional[1]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.
  • Demonstrated clinical safety and research expertise in an appropriate disease area.
  • Expectation of working in the office 3 days a week : When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working give us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

    AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification

    Date Posted

    06-May-2025

    Closing Date

    29-May-2025Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact accommodations@Alexion.com. Alexion participates in E-Verify.

    #J-18808-Ljbffr

    serp_jobs.job_alerts.create_a_job

    Senior Director Program • Boston, Massachusetts, US

    Job_description.internal_linking.related_jobs
    • serp_jobs.job_card.promoted
    Safety Director

    Safety Director

    SyscoBoston, MA, US
    serp_jobs.job_card.full_time
    Health, Safety, And Environmental Manager.This Operating Company (OpCo) based position will lead the implementation of prevention-focused health, safety and environmental (HSE) and security program...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    • serp_jobs.job_card.new
    Senior Director, Global Regulatory Lead, GI & Inflammation

    Senior Director, Global Regulatory Lead, GI & Inflammation

    Takeda PharmaceuticalCambridge, MA, US
    serp_jobs.job_card.full_time
    By clicking the Apply button, I understand that my employment application process with Takeda will commence and that.I provide in my application will be processed in line with.I further attest that...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_hours
    • serp_jobs.job_card.promoted
    Global Safety Program Lead (Senior Director)

    Global Safety Program Lead (Senior Director)

    AstraZeneca SASBoston, Massachusetts, US
    serp_jobs.job_card.full_time
    The individual is accountable to the Global Safety Head for the safety strategy, delivery, and oversight of the assigned asset(s). the role holder will work with safety physicians and scientists re...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_1_day
    • serp_jobs.job_card.promoted
    Super Pollutant Program Director

    Super Pollutant Program Director

    Cascade ClimateBoston, MA, US
    serp_jobs.job_card.full_time
    Super Pollutant Program Director.Join Cascade Climate, a global nonprofit propelling high-potential climate solutions from the margins to the mainstream. The climate crisis has outpaced our response...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Super Pollutant Program Director

    Super Pollutant Program Director

    Cascade Climate, Inc.Boston, MA, United States
    serp_jobs.job_card.full_time
    Join Cascade Climate, a global nonprofit propelling high-potential climate solutions from the margins to the mainstream.The climate crisis has outpaced our response. We need dramatically expanded ef...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Senior Program Director

    Senior Program Director

    Bay Cove Human ServicesBoston, MA, United States
    serp_jobs.job_card.full_time
    Bay Cove Human Services’ mission is to partner with people to overcome challenges and realize personal potential.Bay Cove pursues this mission by providing individualized and compassionate services...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Senior Program Director

    Senior Program Director

    VinfenBoston, MA, United States
    serp_jobs.job_card.full_time
    Be among the first 25 applicants.As a Senior Program Director (SPD), you will oversee the clinical, financial, and administrative operations of specified programs. In your role you will work togethe...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Director, Global Audit Program

    Director, Global Audit Program

    Alnylam PharmaceuticalsCambridge, MA, US
    serp_jobs.job_card.full_time
    Director, Global Audit Program.The Director, Global Audit Program is responsible for leading the strategy, execution, and oversight of Alnylam's GxP internal and external audit programs; as well as...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    • serp_jobs.job_card.new
    Safety Director

    Safety Director

    Sysco Northeast RdcBoston, Massachusetts, US
    serp_jobs.job_card.full_time
    All the relevant skills, qualifications and experience that a successful applicant will need are listed in the following description. This Operating Company (OpCo) based position will lead the imple...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_hours
    • serp_jobs.job_card.promoted
    Senior Director, Global Program Management

    Senior Director, Global Program Management

    VirtualVocationsLowell, Massachusetts, United States
    serp_jobs.job_card.full_time
    A company is looking for a Senior Director, Global Program Management, Obesity - US Remote.Key Responsibilities Lead the development and delivery of strategic plans in collaboration with the Prod...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Super Pollutant Program Director

    Super Pollutant Program Director

    Homeworld Collective IncBoston, MA, United States
    serp_jobs.job_card.full_time
    Join Cascade Climate, a global nonprofit propelling high-potential climate solutions from the margins to the mainstream.The climate crisis has outpaced our response. We need dramatically expanded ef...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    US Licensed Global Safety Officer

    US Licensed Global Safety Officer

    VirtualVocationsLowell, Massachusetts, United States
    serp_jobs.job_card.full_time
    A company is looking for a Global Safety Officer (GSO), Global Safety Medical Director - Obesity, US - Remote.Key Responsibilities : Validate safety signals and lead safety signal assessments Dev...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_1_day
    • serp_jobs.job_card.promoted
    Global Safety Program Lead (Senior Director)

    Global Safety Program Lead (Senior Director)

    AstraZeneca GmbHBoston, MA, United States
    serp_jobs.job_card.full_time
    The individual is accountable to the Global Safety Head for the safety strategy, delivery, and oversight of the assigned asset(s). the role holder will work with safety physicians and scientists re...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    • serp_jobs.job_card.new
    Global Safety Medical Director

    Global Safety Medical Director

    VirtualVocationsDorchester, Massachusetts, United States
    serp_jobs.job_card.full_time
    A company is looking for a Global Safety Medical Director - Hematology / Oncology.Key Responsibilities Validate safety signals and lead safety signal assessments Develop and maintain Core Safety I...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_hours
    • serp_jobs.job_card.promoted
    Safety Director, Advanced Technology

    Safety Director, Advanced Technology

    Suffolk ConstructionBoston, MA, US
    serp_jobs.job_card.full_time
    Suffolk is seeking people who are bold.Create, communicate, enforce, and identify opportunities for improvements in corporate safety programs. Mentor and supervise Safety Managers as required by Reg...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Senior Program Director Technology Modernisation

    Senior Program Director Technology Modernisation

    State StreetQuincy, MA, US
    serp_jobs.job_card.full_time
    Senior Vice President, Technology Modernization & Governance.We are seeking a strategic, execution-oriented technology leader to drive the governance and delivery of a multi-year, enterprise-wide m...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Director, Safety Science

    Director, Safety Science

    Generate BiomedicinesSomerville, MA, US
    serp_jobs.job_card.full_time
    Generate : Biomedicines is a new kind of therapeutics company existing at the intersection of machine learning, biological engineering, and medicine pioneering Generative Biology to create breakthr...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    • serp_jobs.job_card.new
    Operations Safety Engineering Lead

    Operations Safety Engineering Lead

    VirtualVocationsLowell, Massachusetts, United States
    serp_jobs.job_card.full_time
    A company is looking for an Operations Safety Engineering Lead for Autonomous Vehicle Development.Key Responsibilities Provide end-to-end safety leadership for AV operations across various drivin...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_hours
    • serp_jobs.job_card.promoted
    Senior Director, Business Process Owner, Medical Safety Sciences

    Senior Director, Business Process Owner, Medical Safety Sciences

    Takeda PharmaceuticalsBoston, MA, US
    serp_jobs.job_card.full_time
    Primarily responsible for the design, procedural documentation, implementation, management, and oversight of the Reference Safety Information (RSI) end-to-end process in QMS and other business guid...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Residential Program Director - SLP

    Residential Program Director - SLP

    AdvocatesNorth Reading, MA, US
    serp_jobs.job_card.full_time
    The Residential Program Director is responsible for the successful administration and management of the clinical, budgetary and business operations of the program. They serve as interdisciplinary te...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days