Senior Director, Pharmacoepidemiology – Oncology - Cambridge, United Kingdom - Workday

Description

For Current Gilead Employees and Contractors:

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Job Description

The Real-World Evidence (RWE) function at Gilead is part of the Clinical Data Sciences (CDS) group within the Clinical Development organization and aims to unlock the power of Real-World Data (RWD) to help transform innovations to life-changing medicines for patients.

The Senior Director, Pharmacoepidemiology – Oncology reports to the Executive Director, RWE Therapeutic Area (TA) Head-Oncology and has primary accountability for the execution of post marketing pharmacovigilance commitments and other non-experimental planned and ad hoc safety studies, in support of Oncology products for Gilead. The incumbent will serve as the key Pharmacovigilance and Safety subject matter expert for Oncology and serve as a strategic partner to the Global Safety leads, RWE Oncology Franchise Leads, Post Authorization Study (PAS) lead, and cross-functional stakeholders to ensure excellence in the execution of Pharmacovigilance and Safety studies at the global level.

The Senior Director, Pharmacoepidemiology – Oncology will oversee a team of observational research scientists and work within a matrix organization and advocate for the appropriate level of resources to ensure the timeliness, quality, and utility of Pharmacovigilance and Safety studies and analyses required by internal and external stakeholders (including regulators). Success in this role requires excellence in communication and stakeholder & people management, design and conduct of epidemiologic studies, direct expertise in use of RWE including pharmacovigilance methodology and planning and application of appropriate and contemporary analytical methods at different stages of the product development and commercialization processes, and the ability to lead and manage cross-functional efforts and resources.

The Senior Director, Pharmacoepidemiology – Oncology will be responsible for maintaining an up to date overview of the needs of the Global Safety teams and pharmacovigilance commitments of local affiliates and global teams to support oncology products in Gilead. It will be important for the Senior Director, Pharmacoepidemiology – Oncology to communicate, and effectively with the SD RWE Franchise Oncology leads & PAS lead in RWE to determine which studies are likely to be in consideration and plan for the development of studies in good time. The Senior Director, Pharmacoepidemiology – Oncology lead will also be required to work effectively with the Global and local Clinical Operations Leads, Global and local Medical Affairs leads for local pharmacovigilance commitments to ensure smooth set up of studies and ensure good communication throughout study timeline.

Duties & Responsibilities

• Serve as the primary point of accountability for the timely development, execution, and communication of specified and ad hoc safety and specified pharmacovigilance/non-experimental studies for individual products and their pipeline/lifecycle indications in Oncology.
• Provide functional perspective and subject-matter expertise on RWE methods and requirements at both the global/regional level and the TA level, including review of Pharmacovigilance and Safety analysis plans developed internally and externally.
• Ensure collaboration and coordination of Pharmacovigilance and Safety Lead activities within RWE Oncology Therapy Area teams and other Pharmacovigilance & Safety RWE leads in the broader RWE team.
• Lead a team of observational research scientists and work within a matrix organization to deliver, within time, budget, and quality standards including, but not limited to: pharmacovigilance studies, ad hoc and specified safety analyses, patient registries, and drug utilization studies.
• Communicate effectively about the utility of RWE and drive use of study results to support internal and external decisions.
• Ensure expert communication of observational research results, including development of study reports and pertinent sections of regulatory documents, publications, white papers, press releases, etc.
• Represent the RWE function in internal cross-functional initiatives and external organizations, such as industry associations, professional societies, or regulatory working groups.
• Foster close collaborations with quantitative functions within CDS (e.g., Biostatistics, Bioinformatics), as well as partners in Global Patient Safety, Clinical Development, Regulatory Affairs, Clinical Operations, Medical Affairs and Global Value and Access, to anticipate and meet the evidence needs of regulators, providers, and patients.
• Actively identify the need for the development of processes or gaps in training documents aimed at increasing the efficiency, quality, and impact of functional activities.

Requirements

• Doctoral degree (e.g. PhD, MD, ScD, PharmD) and/or Master's degree (e.g. MSc) in Epidemiology or related discipline, such as Outcomes Research, Medicine, Biostatistics from an accredited institution, with a strong level of relevant, post-graduation experience to be in the biopharmaceutical industry.
• A strong track record of scientific publications demonstrating expertise in observational study design, analysis, and interpretation and direct experience with different applications of RWE, especially in support of Pharmacovigilance and Safety.
• Preference for understanding of the Oncology therapeutic area, including disease knowledge, current treatment practice and guidelines, pertinent clinical trial endpoints and safety outcomes.
• Experience leading, coaching and managing people in a global setting.
• Solid working knowledge of regulatory guidelines pertaining to RWD and RWE studies, especially pharmacovigilance studies.
• Demonstrated ability to function with a high level of autonomy and develop productive cross-functional collaborations.
• Ability to manage priorities, resources, and performance targets, in a changing environment.
• Ability to foster close collaborations with others across functions to ensure shared purpose and clear accountability for future decisions.
• Well-developed cross-cultural sensitivity.

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.