- Leads the MR group and sets clear and advanced goals for the group.
- Develops and refines MR strategies, processes, standards, practices, efficiencies, and capabilities to meet regulatory requirements and beyond. This includes the process and strategy for causality and labelling assessment of Individual Case Safety Reports (ICSRs), analysis of similar events, and IND Safety Reporting determination.
- Recruits, develops, and maintains key talent medical reviewers.
- Coaches direct reports on their performance, development and career interests.
- Provides medical input to Strategic Operations and Patient Safety that influences the direction and effectiveness of the organization overall.
- Responds to medical review-related questions from regulatory agency or other functions within the Company in a timely manner.
- Plays a leadership role in Patient Safety cross-functional teams.
- Communicates to highest levels of senior management key pharmacovigilance findings.
- Oversees or performs medical review of individual case safety reports (ICSRs) and line listings for investigational and marketed products as needed.
- Oversees or performs peer retrospective medical review quality control (MRQC) for individual case safety reports and line listings.
- Provides medical consultation to Patient Safety (PS) Strategic Operations groups including Literature Management, Coding Strategy, and Autolabeling Management on an ad hoc basis.
- Organizes regular Medical Review team meetings and promotes learning.
- Develops and maintains MR related procedural documents.
- Ensures meticulous adherence to deadlines. Anticipates events which might impact deadlines and mitigates accordingly.
- Represents MR in audits/inspections.
- Ensures appropriate and timely collaboration between MR and other groups for medical review activities.
- Provides accurate and thorough input and recommendations into resource plans required to complete own deliverables.
- Ensures the team and the assigned work comply with established practices, policies, and processes and any regulatory or other requirements.
- MD/DO degree or equivalent.
- Completion of an accredited medical or surgical residency program is required. Board certification is preferred.
- A minimum of 6 years' experience in pharmacovigilance with substantial knowledge of drug safety including medical review of ICSRs.
- Extensive knowledge of US and global ICSR medical review regulations and IND Safety Reporting.
- Industry experience of clinical safety, pharmacovigilance operations, and medical review. Oncology experience preferred.
- Line management (direct reports) experience is strongly preferred.
- Proven track record of effective people leadership, as evidenced through past effectiveness with employee engagement, development and retention either with direct reports or through matrix leadership responsibilities.
- Strong track record of cultivating and maintaining strategic relationships and collaborations both internally and externally.
- MD / DO or equivalent with completion of an accredited medical or surgical residency program. Board certification is strongly preferred. Significant experience working in drug safety / PV or a related field in the biopharma industry, clinical research, health administration, health policy, epidemiology, or academic or subspeciality medicine. Biopharma industry experience is preferred.
- Knowledge of the drug development process, Good Clinical Practices (GCP) and Good Pharmacovigilance (GVP), including worldwide PV regulations and their application to individual case safety reports.
- Excellent scientific/clinical and analytical knowledge base, with ability to assess individual case safety reports and understand the safety/medical implications.
- Leadership skills including problem solving, negotiation skills, organization, and planning.
- Proven ability to manage global teams.
- Proven abilities to make significant contributions to Patient Strategy (PS) strategic planning and lead significant process improvements in PS.
- Exceptional interpersonal skills and understanding of team dynamics.
- Strong communication and organizational skills. Demonstrable abilities to effectively communicate project direction and status to varying organizational levels, including leadership teams, executives, and steering committees. Able to distill complex matters into a clear business case and roadmap for execution.
- Strong negotiation and conflict resolution skills.
- Strong coaching capabilities to mentor/develop staff. The salary range for this position is: $274, $355, Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
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Senior Director, Medical Review - Foster City, United States - Gilead Sciences, Inc.
Description
Description
You will establish visions and objectives for the Medical Review (MR) group taking into consideration of the departmental short- and long-term goals, lead the MR group to deliver timely and high-quality medical review, ensure the MR process and procedure in alignment with regulatory requirements, and provide strategic medical input to Strategic Operations as well as Patient Safety.
EXAMPLE RESPONSIBILITIES:
REQUIREMENTS:
We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.
U.S. Education & Experience
Rest of World Education & Experience
Knowledge & Other Requirements
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.
Senior Director, Medical Review professionals in Foster City
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vijay yelanji
Manager, Architect, Tech Lead and Developer