Medical Director, SERM

Job description

Site Name: USA - North Carolina - Research Triangle Park, USA - Pennsylvania - Upper Providence
Posted Date: Jun 16 2020

Are you energised by the opportunity to work with global stakeholders to design, deliver and embed critical highly visible safety programs that have a global impact? If so, this role could be an ideal opportunity to explore. As a Medical Director in the Safety Evaluation and Risk Management group, you will play a key role in supporting the Central Safety Leadership Team, and the broader business at both a strategic and operational level.

ROLE SUMMARY

  • Provides high level medical expertise in the safety evaluation and risk management of key GSK assets or other highly complex products in clinical development and/or the post-marketing setting
  • Ensures that adverse event and other safety information is efficiently evaluated in order to meet global compliance and regulatory requirements, identify the need for product labelling updates and drive proactive implementation of risk management initiatives
  • Has a proven ability to lead safety evaluation activities, ensures that appropriate safety objectives and risk minimisation strategies are included in clinical development programmes and shows confidence, credibility and influence at all levels of the organisation
  • Presents the disease area or product area safety strategy at key internal GSK meetings and represents GSK externally at meetings with regulatory authorities, outside consultants and other companies such as licensing partners.
  • Accountable for medical review and sign-off for regulatory documents, including periodic safety update reports (PSURs)

RESPONSIBILITIES

  • Safety Governance and Risk Management activities
  • Signal Detection, Evaluation and Labelling
  • Regulatory Reports and Submission
  • Other SERM Activities including driving the review or production of the SERM component of Safety Data Exchange Agreements; participating in due diligence activities; providing support to GSK Legal for product liability litigation; providing input to, or participating in, meetings of an independent data monitoring committee (IDMC) or GSK internal safety review committee (iSRC), etc.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

  • Medical Degree
  • Expert evaluation skills and analytical thinking
  • Outstanding medical writing skills
  • Sound computing skills
  • Expert knowledge of relevant pharmacovigilance regulations and methodologies applicable to SERM activities
  • Expertise in causality assessment, evaluation of safety signals and proactive risk management strategies including management of labelling changes, physician and patient education
  • Sound knowledge of the therapeutic area of assigned GSK products
  • Sound knowledge of other related disciplines, e.g. statistics, epidemiology relevant to assessing drug utilization and safety at the population level
  • In depth knowledge of medical and drug terminology and a sound foundation in pharmacology. Good medical judgement and ability to make medical decisions
  • Clear understanding of clinical development process
  • Clear understanding of drug approval process in major countries

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. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

  • Agile and distributed decision-making – using evidence and applying judgement to balance pace, rigour and risk, governance and control, managing ambiguity and paradox.
  • Managing individual performance.
  • Creating a performance culture and driving results, prioritisation, execution, delivering performance.
  • Setting strategic direction and leading on-going organisational transformation.
  • Building a resilient organisation.
  • Building strong relationships and collaboration in service of common goals, engaging the organisation and building trusted external networks for mutual benefit.
  • Managing P&L and capital allocation.

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