Head - Safety Science & Research, Epidemiology and

**Site Name**: USA - Pennsylvania - Upper Providence, Home Worker - GBR, UK - Hertfordshire - Stevenage, UK - London - Brentford, USA - Pennsylvania - Philadelphia

As Head (Senior Director) of Safety Science and Research for the Epidemiology and PCO group (part of Value Evidence and Outcomes (VEO) within R&D) you will be responsible for 1) managing the strategic input and oversight of epidemiology into safety and risk management programs, including the R&D pipeline and marketed portfolio and 2) providing epidemiologic and real-world analytic support to the Human Genetics and Discovery Medicine functions within GSK’s Research organization.

In this role you will be accountable for promoting best practice and innovation in the use of epidemiology, RWD and advanced analytics for safety and risk management, including patient-reported or clinician-observed outcomes; ensuring the Epidemiology group meets its key metrics in support of Safety Review Teams; representing the VEO function at GSK’s Global Safety Board and the Global Safety Leadership Team; and developing and executing early epidemiology evidence plans to support key Research assets.

This is an opportunity to join a large epidemiology group within a major pharma company, fitting into an integrated VEO organisation which allies the disparate functions of PCO, Safety and more. As such, there is fantastic opportunity for lateral growth and to expand the breadth of your knowledge from this position. You will be working directly with senior leaders in safety, but also will be closely engaged with an extremely innovative research and development organisation inside GSK.

**Details** **(**_Your Responsibilities_**)**:

- This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following _

**_
Safety Science_**
- Working directly with the Head of Epidemiology, Epidemiology TA Heads, Head of Safety, and Safety Evaluation and Risk Management (SERM) TA Heads and other stakeholders to:

- Understand and influence development of safety and risk management strategies for assets
- Evaluate the key benefit risk knowledge gaps and use influence to ensure Epidemiologists translate gaps into epidemiology programs tailored to asset needs and these are reflected at the Safety Review Team
- Champion prioritization of projects that contextualize safety using RWD and optimally plan for post-marketing activities as part of Integrated Evidence Plans
- Effectively communicate and advocate for an enterprise-wide, and when appropriate TA specific, framework for safety epidemiology contributions and innovation, including the management of Post-Authorization Safety Studies (PASS) and Targeted Safety Studies (TSS)
- Managing a team including the Senior Director, Classic and Established Products and Vulnerable Populations Lead
- To liaise with key local operating companies (Japan, China, Korea, and others when applicable) to ensure global Epidemiology input to national pharmacovigilance activities
- Representing VEO on GSK’s Global Safety Board serving as senior most epidemiologist in safety governance, ensuring epidemiology and RWD are applied appropriately in support of pharmacovigilance activities
- Representing the Epidemiology function, particularly as it relates to pharmacovigilance, externally in regulatory inspections and meetings, public-private partnerships and at scientific societies
- Representing the Epidemiology function at the Global Safety Leadership Team
- To partner with Non-Interventional Study (NIS) Global Business Owner and Head of PV Excellence to ensure regulatory guidance for risk management related NIS are effectively embedded within relevant GSK processes

**_
Research_**
- To partner with key stakeholders in Human Genetics and Discovery Medicine functions to prioritize epidemiologic support to early assets
- Managing a group of 2-4 epidemiologists to develop and execute early epidemiology evidence plans in support of key Research assets
- Leading resourcing strategy; provide guidance and support to each team member on their development of the specific disease & early asset support strategy, work priorities, and delivery; conduct scientific review and governance of team members’ work output; discuss and agree performance and development objectives.
- To provide advice and guidance for best practice in epidemiology evidence generation strategies and methodologies, including enabling internal and external scientific advice to the Research organization

**_
General_**

You’ll serve on the Epidemiology and PCO Leadership Team and lead departmental and divisional initiatives to continuously improve operations and advance innovative science and analytics

**_
Why you?
- **

**Basic Qualifications**:

- We are looking for professionals with these required skills to achieve our goals:_
- Doctorate in epidemiology
- 10 + years’ experience conducting pharmacoepidemiologic researc