Vice President, Head of Oncology Clinical Safety & Pharmacovigilance

An exciting opening to lead the entire global Clinical Safety & Pharmacovigilance organization of our growing Oncology business!

Oncology is a core area of intensive focus at GSK and while much progress has been made in the past few years, more can and will be done toredefine expectations in cancer care.

As Vice President, Head of Oncology Clinical Safety & Pharmacovigilance, you will be responsible for leading and co-ordinating all clinical safety and pharmacovigilance activities for the global GSK Oncology business, as well as the therapeutic immunology portfolio.

The role reports to the Senior Vice President, Clinical Safety and Pharmacovigilance in the GSK Global Development organization and is also embedded as an integral part of the oncology medical team, with a strong connection to the oncology business.

It is a highly visible position serving on various high-profile leadership teams and governance boards, including both the Global Safety and Oncology Leadership Teams, and the enterprize-wide Global Safety Board.

This is a global senior leadership position with a total reporting group in the range of 60 FTEs, including senior safety physicians and scientific functional leaders within the assigned Global Safety teams. You will oversee both strategic and day-to-day perspectives of safety evaluation and risk management activities, including but not limited to:

• Oncology portfolio.
• Therapeutic Immunology portfolio.
• Early Phase Group.

The group's remit includes safety evaluation and risk management for all GSK oncology and therapeutic immunology assets in clinical development as well as all marketed products in these therapeutic areas.

This role may be based at the GSK offices in Collegeville, Upper Providence PA, Waltham MA or Research Triangle Park NC

Your responsibilities

• Lead aspects of the overall strategic plan for Oncology Safety.
• Delivery of leadership on safety and related issues to key customer groups involved with medical products covered by Oncology Safety. This includes but is not limited to clinical, epidemiology, biostats, medical affairs, manufacturing, in-licensing, regulatory, compliance, and legal.
• Build and maintain close working relationship with Head(s) of the departments in Central Safety on cross organizational initiatives and on transfer/overlap of medicines between teams.
• Compliance with relevant pharmacovigilance regulations.
• Demonstrate effective and dynamic leadership in this highly regulated area.
• Leadership/sponsorship of safety evaluation and risk management improvement initiatives.
• Establish a pragmatic, flexible, focused approach to meeting time, cost and quality measures.
• Ability to build effective networks for Central Safety Department throughout GSK.
• Establish and monitor proactive resourcing strategy for Oncology Safety.
• Demonstration of superior problem solving in complex situations.
• Ability to lead and manage significant change initiatives.
• Global point accountability for monitoring and assessment for safety (and related) topics and issues, for development and marketed medicines.
• Sits on Oncology Leadership Team.
• Reinforce, or establish where necessary, common principles/thresholds for concern for safety issues and ensure decisions are consistent with these principles.
• Ability to interpret and make decisions on complex safety and product quality issues including medical relevance and impact, particularly if impacting benefit risk.
• Engagement in medical governance via Global Safety Board, safety panels, and other various company governance boards and leadership teams.
• Overview of Oncology Product Incident Review Committees (PIRCs) and product recalls due to product quality issues.

Complexity

Due to the universal application of safety related activities at all levels of discovery, development and life cycle management and therefore its impact on overall portfolio, sales and growth of GSK, you will:

• Work across the R&D, Commercial Strategy, and the Regulatory matrix environment.
• Work across product pipeline in development and products in the market.
• Network with leaders of other departments.
• Partner with Safety Heads of other therapeutic areas, QPPV as well as other senior leaders in the Central Safety Department.
• Network externally with Safety functions in other companies as well as relevant stakeholders in regulatory agencies and medical associations.

Management of global safety teams will include:

• People management, recruiting, training, development and retention of high-caliber staff.
• Compliance with internal SOPs, working practices, and external regulations.
• Proactive resource planning and allocation across groups and sites.

Why you?

Basic Qualifications:

• Medically qualified with significant experience of oncology, clinical medicine or drug safety.
• 10-12 (+) years of increasing experience in the Pharmaceutical or Biotech industry working in Clinical Development, Pharmacovigilance, Drug Safety or a related field.
• Leadership skills and people management experience in a complex organizational environment.
• At least 8 years' experience in pharmacovigilance/regulatory, particularly in the post-marketing area.
• Experience of decision making on product safety and quality issues.
• Must have an in-depth understanding of FDA, EMA and other Health Agency regulations regarding pharmacovigilance activities.

Preferred Qualifications

• Additional experience in Pharmaceutical Medicine (Drug Discovery, Drug Development, Medical Affairs, Medical Information) is an asset.

Behavioral Competencies

• Essential to be an effective team member and strong leader in a cross-functional department.
• Very strong communication and influencing skills.
• Strategic and innovative thinking.
• Strong analytical skills.
• Rigorous and well-organized.
• Proven track record in capability building in Drug Safety, Risk Management / Pharmacovigilance.
• In depth knowledge and experience of design, conduct and interpretation of clinical trials and pharmacoepidemiology studies.
• Proficient in prioritizing assignments and able to adapt to rapidly changing priorities.
• Extensive experience in proactive risk management, ad hoc crisis management, monitoring of safety issues, and a solution-oriented approach to crisis issues under pressure.
• Outstanding change management capabilities.
• Pragmatism, with good clinical and pharmaceutical judgement.

*LI-GSK

Why GSK?

Our values and expectationsare at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect Integrity along with Courage, Accountability, Development, and Teamwork in a culture of Innovation, Performance and Trust.

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