Current jobs related to Senior Director, Global Oncology Therapeutic Area Safety Physician - Cambridge, Cambridgeshire - Gilead Sciences, Inc.


  • Cambridge, Cambridgeshire, United Kingdom Gilead Sciences International, Ltd. Full time

    Job SummaryWe are seeking a highly experienced and skilled Senior Director, Global Oncology Therapeutic Area Safety Physician to join our team at Gilead Sciences International, Ltd.Key ResponsibilitiesServe as a senior scientific and clinical expert for the safety profile of products in therapeutic areas, providing strategic guidance and leadership to...


  • Cambridge, Cambridgeshire, United Kingdom Gilead Sciences International, Ltd. Full time

    Job SummaryWe are seeking a highly experienced and skilled Senior Director, Global Oncology Therapeutic Area Safety Physician to join our team at Gilead Sciences International, Ltd.Key ResponsibilitiesServe as a senior scientific and clinical expert for the safety profile of products in therapeutic areas, providing strategic guidance and leadership to...


  • Cambridge, Cambridgeshire, United Kingdom Gilead Sciences International, Ltd. Full time

    Job SummaryWe are seeking a highly experienced and skilled Senior Director, Global Oncology Therapeutic Area Safety Physician to join our team at Gilead Sciences International, Ltd.Key ResponsibilitiesServe as a senior scientific and clinical expert for the safety profile of products in therapeutic areas, providing strategic guidance and leadership to...


  • Cambridge, Cambridgeshire, United Kingdom Gilead Sciences International, Ltd. Full time

    Job SummaryWe are seeking a highly experienced and skilled Senior Director, Global Oncology Therapeutic Area Safety Physician to join our team at Gilead Sciences International, Ltd.Key ResponsibilitiesServe as a senior scientific and clinical expert for the safety profile of products in therapeutic areas, providing strategic guidance and leadership to...


  • Cambridge, Cambridgeshire, United Kingdom Gilead Sciences International, Ltd. Full time

    Senior Director, Global Oncology Therapeutic Area Safety Physician Gilead Sciences International, Ltd. is seeking a highly motivated and experienced Senior Director to lead our global oncology safety efforts. This role will be instrumental in ensuring the safety of our patients while driving the development and implementation of robust pharmacovigilance...


  • Cambridge, Cambridgeshire, United Kingdom Gilead Sciences International, Ltd. Full time

    Senior Director, Global Oncology Therapeutic Area Safety Physician Gilead Sciences International, Ltd. is seeking a highly motivated and experienced Senior Director to lead our global oncology safety efforts. This role will be instrumental in ensuring the safety of our patients while driving the development and implementation of robust pharmacovigilance...


  • Cambridge, Cambridgeshire, United Kingdom Gilead Sciences International, Ltd. Full time

    Job SummaryWe are seeking a highly experienced and skilled Senior Director to lead our Global Oncology Therapeutic Area Safety and Medical Expert team at Gilead Sciences International, Ltd.Key ResponsibilitiesStrategic Leadership: Provide senior-level scientific and clinical expertise for the safety profile of products in therapeutic areas, defining global...


  • Cambridge, Cambridgeshire, United Kingdom Gilead Sciences International, Ltd. Full time

    Job SummaryWe are seeking a highly experienced and skilled Senior Director to lead our Global Oncology Therapeutic Area Safety and Medical Expert team at Gilead Sciences International, Ltd.Key ResponsibilitiesStrategic Leadership: Provide senior-level scientific and clinical expertise for the safety profile of products in therapeutic areas, defining global...


  • Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full time

    Job SummaryBicycle Therapeutics is seeking a highly experienced and skilled physician leader to join our Clinical Development team as Vice President, Clinical Development. This is a strategic leadership role that will play a critical part in the development of our novel oncology therapeutics.Key ResponsibilitiesLeadership and Strategy: Provide scientific,...


  • Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full time

    Job SummaryBicycle Therapeutics is seeking a highly experienced and skilled physician leader to join our Clinical Development team as Vice President, Clinical Development. This is a strategic leadership role that will play a critical part in the development of our novel oncology therapeutics.Key ResponsibilitiesLeadership and Strategy: Provide scientific,...


  • Cambridge, Cambridgeshire, United Kingdom Petgroomingnw put Tracy Full time

    About the RoleWe are seeking a highly skilled Consultant Physician to join our team at Royal Papworth Hospital, specializing in Thoracic Oncology. As a key member of our respiratory medicine department, you will play a vital role in providing exceptional patient care and contributing to our research initiatives.Key ResponsibilitiesProvide advanced diagnostic...


  • Cambridge, Cambridgeshire, United Kingdom Petgroomingnw put Tracy Full time

    About the RoleWe are seeking a highly skilled Consultant Physician to join our team at Royal Papworth Hospital, specializing in Thoracic Oncology. As a key member of our respiratory medicine department, you will play a vital role in providing exceptional patient care and contributing to our research initiatives.Key ResponsibilitiesProvide advanced diagnostic...


  • Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full time

    Bicycle Therapeutics is seeking a highly motivated physician leader with extensive oncology drug development experience to serve as Vice President, Clinical Development. This leadership role will be based in either Cambridge, UK or Cambridge, MA and will contribute significantly to the growth of our clinical development organization within the exciting...


  • Cambridge, Cambridgeshire, United Kingdom Pfizer Full time

    Job Summary:The Late-Stage Clinical Scientist (non-MD, Senior Manager) is a critical role within the Oncology portfolio, responsible for ensuring the scientific integrity and quality of clinical trials. This position requires a strong understanding of clinical procedures, ICH guidelines, and global regulations.Key Responsibilities:Maintain current scientific...


  • Cambridge, Cambridgeshire, United Kingdom Pfizer Full time

    Job Summary:The Late-Stage Clinical Scientist (non-MD, Senior Manager) is a critical role within the Oncology portfolio, responsible for ensuring the scientific integrity and quality of clinical trials. This position requires a strong understanding of clinical procedures, ICH guidelines, and global regulations.Key Responsibilities:Maintain current scientific...


  • Cambridge, Cambridgeshire, United Kingdom Pfizer Full time

    Job SummaryPfizer is seeking a highly experienced and skilled Clinical Research Director to lead our Late-Stage Oncology portfolio. As a key member of our team, you will be responsible for providing scientific oversight and ensuring the quality of clinical trials.Key ResponsibilitiesProvide scientific expertise and guidance to clinical trial teams to ensure...


  • Cambridge, Cambridgeshire, United Kingdom Pfizer Full time

    Job SummaryPfizer is seeking a highly experienced and skilled Clinical Research Director to lead our Late-Stage Oncology portfolio. As a key member of our team, you will be responsible for providing scientific oversight and ensuring the quality of clinical trials.Key ResponsibilitiesProvide scientific expertise and guidance to clinical trial teams to ensure...


  • Cambridge, Cambridgeshire, United Kingdom Lifelancer Full time

    Job DescriptionJob Title: Director, Global Regulatory Affairs, OncologyJob Summary:We are seeking an experienced and skilled Director, Global Regulatory Affairs, Oncology to join our team at Lifelancer. As a key member of our organization, you will be responsible for developing and implementing regulatory strategies for our assigned programs and products.Key...


  • Cambridge, Cambridgeshire, United Kingdom Lifelancer Full time

    Job DescriptionJob Title: Director, Global Regulatory Affairs, OncologyJob Summary:We are seeking an experienced and skilled Director, Global Regulatory Affairs, Oncology to join our team at Lifelancer. As a key member of our organization, you will be responsible for developing and implementing regulatory strategies for our assigned programs and products.Key...


  • Cambridge, Cambridgeshire, United Kingdom Singular: Building Brilliant Biotechs Full time

    Job DescriptionJob SummaryWe are seeking a highly experienced Senior Director/VP to lead our strategy and portfolio management efforts. As a key member of our leadership team, you will be responsible for developing and executing our business strategy, driving growth and innovation, and ensuring the successful delivery of our therapeutic programs.Key...

Senior Director, Global Oncology Therapeutic Area Safety Physician

4 months ago


Cambridge, Cambridgeshire, United Kingdom Gilead Sciences, Inc. Full time

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site $) to apply for this job.

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

We empower our leaders to step up, share ideas, listen, learn, and lead. We're welcoming bright, diverse, and imaginative minds; we're nurturing them to foster an environment of inclusion and growth where innovation is encouraged. We expect our people leaders to model that environment, and to focus on creating inclusion, developing talent, and enabling teams.

Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact. Join Gilead and help create possible, together.

Job Description

Description:

  • Serves as a senior scientific and clinical expert for safety profile of products in therapeutic areas
  • Defines global product safety strategy and routinely manages and leads functional and cross-functional projects
  • Works under consultative direction towards long-term GLPS goals and objectives; assignments are self-initiated with almost no direct supervision
  • Serves on senior-level cross-functional teams
  • Communicates to highest levels of senior management key pharmacovigilance findings
  • Provides global medical leadership for product-focused safety activities
  • Provides global strategic input to the organization to mitigate pharmacovigilance-related risk
  • Executes process changes and initiatives based on deep understanding of good pharmacovigilance practices (GVP) and other regulatory guidance
  • Participates in standard operating procedure (SOP) updates, audits, data analysis, and other ad hoc activities
  • Collaborates with Medical Safety Science- Global TA Safety Scientists in proactive identification and assessment of safety signals and trends, and supports management of any potential safety issues

Essential Duties:

  • Oversees clinical development and medical safety support for all project related activities for multiple products.
  • Provides medical strategy and input into key regulatory decisions pertaining to the safety of multiple products, including representing the GLPS Department at advisory panels and meetings with regulators or other internal and external stakeholders.
  • Establishes the direction of pharmacovigilance activities for assigned products and provides global medical leadership and input into all aspects of safety of assigned molecules within the Oncology TA including surveillance programs, aggregate review, and risk management planning.
  • Leads a portion of BLA submission activities.

Requirements:

  • MD/ DO / Pharm D degree or equivalent. Completion of an accredited medical or surgical residency program is required. Board certification is preferred.
  • 6+ years (with MD or PharmD) in pharmacovigilance, drug development or applicable role in the pharmaceutical industry with significant knowledge of relevant regulatory requirements and substantial knowledge of drug safety including previous experience in a leadership role in the pharmaceutical industry.
  • Experience in Hematology/ Oncology / Immunology is preferred.
  • Experience in a basic science laboratory and/or proficiency in translational research is preferred.
  • Experience in submission of BLA/NDA is preferred.
  • Demonstrates an excellent scientific/clinical and analytical knowledge base, with ability to assess data and understand the safety/medical implications.
  • Possesses significant knowledge of EU and FDA pharmacovigilance guidelines, good clinical practice (GCP), and clinical research methodology.
  • Establishes recognition as a clinical and scientific expert on project and cross-functional teams and "end-line" decision maker for product safety decisions on behalf of GLPS.
  • Demonstrates ability to independently lead crisis management scenarios.
  • Demonstrates ability to self-initiate pharmacovigilance processes.
  • Experience in a basic science laboratory and/or proficiency in translational research is preferred.
  • Experience in submission of BLA/NDA is preferred.

Equal Employment Opportunity (EEO)

It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual's gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site $) to apply for this job.

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.