Vice President, Head of Speciality Clinical Safety & Pharmacovigilance, Open to flexible working

Expiring today

Location
Brentford (City/Town), London (Greater)
Salary
£Competitive
Posted
12 Nov 2020
Closes
27 Nov 2020
Ref
270691
Contract Type
Permanent

An exciting opening to head the Specialty division of our global Clinical Safety & Pharmacovigilance organization, leading a large team supporting a broad section of the global GSK pharma business!

This is a global senior leadership position with a total reporting group in the range of 100 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:

  • Respiratory portfolio, both development and marketed products.
  • Classic portfolio.
  • Established portfolio.
  • Generics portfolio.
  • Safety evaluation and risk management activities for ViiV Healthcare 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 Specialty medical team, with a strong connection to the business.

It is a highly visible position serving on various high-profile leadership teams and governance boards, including both the Global Safety Leadership Team and Specialty R&D Leadership Team, and the enterprise-wide Global Safety Board.

This role will be based at GSK House, the company's global corporate headquarters in Brentford, London, UK.

Your responsibilities

  • Contributes to and leads selected aspects of overall strategic plan for Speciality Safety.
  • Sits on Specialty R&D Leadership Team.
  • Delivery of leadership on safety and related issues to key customer groups involved with medical products covered by Speciality Safety. This includes but is not limited to clinical, epidemiology, biostats, medical affairs, manufacturing, in-licencing, regulatory, compliance, and legal.
  • Close working relationship with Head(s) of the departments in Central Safety on cross-organisational initiatives and on transfer/overlap of medicines between teams.
  • Compliance with relevant pharmacovigilance regulations.
  • Demonstrate effective and dynamic leadership in 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 Speciality Safety.
  • Demonstration of superior problem solving and clinical judgement 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.
  • 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 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 and maintain a suitable network outside GSK concerning safety related matters.
  • Partner with Safety Heads of other therapeutic areas, QPPV as well as other senior leaders in the Central Safety Department.
  • Be a member of Specialty R&D Leadership Team.

Management of global safety teams will include:

  • People management, recruiting, training, development and retention of high-calibre 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 (or equivalent) with significant experience of clinical medicine, preferably including cardiology and/or respiratory.
  • 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.

Behavioural 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-organised.
  • 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 prioritising 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 expectations are 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.

As a company driven by our values of Patient focus, Transparency, Respect and Integrity, we know inclusion and diversity are essential for us to be able to succeed. We want all our colleagues to thrive at GSK bringing their unique experiences, ensuring they feel good and to keep growing their careers. As a candidate for a role, we want you to feel the same way.

As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class*(*US only).

We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

Please don't hesitate to contact us if you'd like to discuss any adjustments to our process which might help you demonstrate your strengths and capabilities.

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