- 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 - Foster City, United States - BioSpace
Description
Job DetailsSenior Director, Global Oncology Therapeutic Area Safety Physician
United States - California - Foster CityUnited States - New Jersey - Parsippany
Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead's therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
Making an impact on a global scale
Inclusion is one of the company's five core values. That's because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.
When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible
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
For additional benefits information, visit:
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
For jobs in the United States:
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
PAY TRANSPARENCY NONDISCRIMINATION PROVISION
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
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