- 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
- 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.
- 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.
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Senior Director, Global Oncology Therapeutic Area Safety Physician - Cambridge, United Kingdom - Gilead Sciences, Inc.
Description
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:
Essential Duties:
Requirements:
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.
