Job description
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Job Description
We are looking to hire a Senior Director, Patient Safety role for the Established Products Portfolio team. This role can be based in either in the UK or the US, and open to candidates with either physicians or scientist background.
FUNCTION: Medical Safety Science (MSS) / Patient Safety (PS) Established Portfolio (EP) Safety Physicians / Safety Scientist
POSITION OVERVIEW:
- You will oversee the MSS product lifecycle management for a portfolio of established products.
- You will provide strategic input into cross-functional planning and execution for the Established Products portfolio.
- You will ensure that signal detection, risk minimization activities, and aggregate safety reports are performed in a timely and quality manner.
- You will also provide input into responses to regulatory agency inquiries, pharmacovigilance (PV) processes and projects and PV or other audits and inspections.
- You may be assigned responsibilities as a Global Safety Lead (GSL) or Global Safety Strategy Lead (GSSL) with responsibilities for managing a group of products/or indications and acting as the expert, strategic partner across Gilead regarding these compounds.
- You will play a lead role within MSS by contributing to the group’s short- and long-range strategy, infrastructure and resource plans, and long-range capability development.
- You will also mentor and develop future MSS leaders.
- You will be responsible for establishing what activities for established products could be outsourced, working with the Vendor company to ensure appropriate resourcing and training is in place and oversight of outsourced work, working with the outsourcing partner to ensure they maintain a high quality of outsourced work and key performance indicators are met.
RESPONSIBILITIES:
- Typically leads and manages a team of direct reports and may manage other people leaders. Hires, develops and retains diverse top talent on the team. Sets clear and elevating goals for the team and individual direct reports. Coaches direct reports on their performance, development and career interests.
- Makes significant contributions to our abilities to hire, develop and retain diverse talent with impact in and outside own team.
- Accountable for the successful oversight and completion of a broad spectrum of MSS activities and deliverables for typically multiple established products, compounds or indications, in compliance with established practices, policies, processes, and any regulatory or other requirements.
- Advises senior management on the MSS strategy and pathway to achieve strategic milestones and objectives.
- May provide input into and influence cross- MSS and Patient Safety (PS) strategies.
- Oversees the preparation of aggregate safety reports and risk management plans (RMPs).
- Oversees signal detection and evaluation activities for assigned products as part of the continuous benefit-risk evaluation throughout the product lifecycle.
- Identifies relevant activities for outsourcing and oversees activities performed by any outsourcing partner, ensuring work is completed to a high standard and key performance indicators are met.
- Supports implementation of decisions from the signal evaluation process, including updates to core safety information and other key safety documents and deliverables.
- Contributes to and/or oversees MSS activities and input related to responses to safety queries from third parties, such as regulatory agencies.
- Plays a leadership role on PS and cross-functional teams, including leadership of special projects, participation in continuous improvement and optimization initiatives, and MSS functional area support in PV audits and inspections.
- Provides accurate and thorough input and recommendations into resource plans required to complete own deliverables. Tracks resources to ensure compliance with agreed resource allocation, including budgets.
- Ensures the team and the assigned work comply with established practices, policies and processes and any regulatory or other requirements.
- May serve as medical monitor for post-authorization safety studies. (This is applicable only for physicians)
- Provides and/or oversees medical input on PV activities for products within the established products portfolio. (This is applicable only for physicians)
SKILLS and EXPERIENCE:
We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills applicable for the US and International (Outside of the US) we seek for this role.
Requirements for the US:
Education requirements (Physicians)
- MD / DO degree or equivalent with 6+ years’ relevant experience.
- Completion of an accredited medical or surgical residency program.
- Board certification is strongly preferred.
Education Requirements (Safety Scientists)
- MA/MS/MBA/PharmD/PhD with 12+ years’ relevant experience.
- BA/BS with 14+ years’ relevant experience.
Experience
- Experience leading cross-functional activities across a broad spectrum of drug safety or related programs, projects and other activities.
- Experience participating in cross-functional projects and teams with responsibilities related to clinical trials or other drug development activities.
- 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.
Requirements for International (Outside of the US):
Education & Experience (Physicians)
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.
Education & Experience (Safety Scientists)
BA/BS or advanced degree in life sciences or related field with significant experience leading or co-leading large-scale, highly complex cross-functional work, projects and teams in life sciences, including leading short- and long-range strategic planning, governance and oversight.
Knowledge & Other Requirements
- Knowledge of the drug development process, Good Clinical Practices (GCP) and Good Pharmacovigilance (GVP), including worldwide PV regulations and their application to safety science activities (aggregate PV reports, risk management plans, signal detection, clinical trials and clinical development).
- In-depth understanding of observational studies used in pharmacoepidemiology and ability to provide sound critique of such studies.
- Strong knowledge of statistical methods used in PV.
- Proven abilities to make significant contributions to Patient Safety (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.
- When needed, ability to travel.
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
Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S., Canada, Australia, Singapore, and Hong Kong employees and contractors to receive the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.
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Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S., Canada, Australia, Singapore, and Hong Kong employees and contractors to receive the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.
For more information about equal employment opportunity protections, please view the
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For Current Gilead Employees and Contractors:
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