Medical Director SERM

Employer
GSK
Location
Research Triangle Park, North Carolina
Salary
Competitive
Posted
Jan 26, 2021
Closes
Feb 27, 2021
Ref
536276
Jobseeker Type
Professional
Organization Type
Corporate
Are you a safety/pharmacovigilance physician with in-depth and hands-on experience?

As the SERM Oncology Medical Director, you will provide high level medical expertise in the safety evaluation and risk management of new oncology medicines in clinical development and/or the post-marketing setting. You will ensure 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.

You will have a proven ability to lead safety evaluation activities, ensuring that appropriate safety objectives and risk minimisation strategies are included in clinical development programmes. You will influence at all levels of the organisation using your experience, confidence and credibility, and represent the disease area or product area safety strategy at key internal GSK meetings and externally at meetings with regulatory authorities, outside consultants and other companies such as licensing partners. Additionally, you will be accountable for medical review and sign-off for regulatory documents, including periodic safety update reports (PSURs).

This role will span the work of project and product safety as practiced by physicians in both the GCSP SERM: Development and GCSP SERM: Mature Products groups. Global Clinical Safety & Pharmacovigilance (GCSP) is responsible for the collection, processing and regulatory reporting of adverse events experienced by patients receiving GSK products and for the ongoing safety evaluation and risk management of all GSK products (marketed or developmental).

GSK considers the clinical safety of its products to be of paramount importance.

Key Responsibilities

Safety Governance and Risk Management activities
  • Drives pharmacovigilance and risk management planning in the clinical matrix and leads production of global Benefit-Risk Management Plans for designated products
  • Leads safety input into regulatory benefit-risk assessments, prepares the regional Risk Management Plans for designated products for submission to regulatory authorities
  • Delivers the clinical safety input into clinical development planning activities
  • Represents GCSP on cross functional Clinical Matrix Teams and/or Project Teams. Leads cross-functional ad hoc teams to address urgent and important product safety issues
  • Reviews and provides technical approval for investigator brochures, protocols, Informed consents, final study reports and external data monitoring committee charters. May lead or participate in discussion at Global Safety Board for safety related findings in clinical development. Presents safety information at clinical investigator and commercial meetings
  • Ensures prompt notification to TA Head of reviewed protocols that are identified as potential PASS
  • Establishes and chairs the Safety Review Team (SRT) for projects in development and provides expert review of data and management of safety issues. Escalates safety signals identified through the Safety Review Process to Global Safety Board if necessary, via the TA Head
  • Accountable for ensuring that risk reduction strategies are included in relevant documents such as clinical study protocols and/or product labelling, as appropriate
  • Provides medical expertise for risk evaluation and risk management planning


Signal Detection, Evaluation and Labelling
  • Drives signal detection for assigned products using available methodologies (including On-Line Signal Management tool, literature review and tools for individual case awareness). Makes recommendations to SERM TA Director for the assessment and prioritisation of safety signals. Provides medical expertise to signal detection and subsequent evaluation for designated products in partnership with the responsible safety scientist
  • Proactively leads the assessment of safety data and discusses the results with the SERM TA Director/ product scientist. Effectively communicates with Clinical Development and other key stakeholders on signal evaluation and labelling recommendations
  • Leads presentations on labelling recommendations at Global Labelling Committee or Global Safety Board
  • Produces regulatory supporting documentation for labelling updates
  • Produces accurate and fit for purpose evaluation documents with clear conclusions, in response to internal or regulatory authority requests for safety data. Provides strategic input into regulatory requests for local label deviations from the company core data sheet
  • Provides medical sign-off for regulatory documentation and represents GCSP as the medical member of labelling discussions
  • Conducts proactive signal detection and evaluation of issues potentially related to product defects or manufacturing issues; drives the escalation and resolution of issues and product complaints
  • In consultation with the product scientist and Clinical Development representatives, prepares the Development Core
  • Safety Information (DCSI) for assigned development products; co-ordinates and chairs meetings and tracks timelines to ensure completion


Regulatory Reports and Submissions
  • Drives production of periodic regulatory documents (PSURs, Annual Reports) according to the agreed process and timelines. Advises on strategy for the content of high profile PSURs
  • Supports the Local Operating Companies by preparing license renewal documentation (e.g. PSUR addenda line listings, clinical overviews, summary bridging reports) as required for each market
  • Accountable for medical input, review and sign-off of periodic reports (e.g. PSURs) and renewal documentation submitted to regulatory agencies
  • Leads the SERM safety component of global regulatory submissions for new products, formulations or indications, with liaison with other functional experts


Other SERM Activities
  • Drives the review or production of the SERM component of Safety Data Exchange Agreements and escalates any deficiencies to the SERM TA Head to ensure quality and integrity of agreement. Advises on the preparation of licensing agreements in therapeutic area of responsibility
  • Participates in due diligence activities by providing expert safety assessments and recommendations
  • Participates in GSK internal or external meetings with project focus, including those with consultants, other companies such as licensing partners and regulatory authorities
  • Provides support to GSK Legal for product liability litigation, as appropriate
  • Accountable for maintaining personal readiness in response to internal audit or regulatory inspection
  • Leads a process improvement initiative within GCSP. Contributes to advancement of methodology and process by generating new ideas and proposals for implementation
  • Raises concerns/ issues (i.e. sentinel events) to senior management in a timely, open and appropriate manner; ensures quality and integrity of issue/event being escalated
  • Trains, coaches and mentors scientists in the medical/scientific aspects of signal evaluation methodology and risk management and preparation of safety reports and other documents
  • May provide medical safety support for the US and RoW Case Management functions. Reviews and approves safety reports to investigators in partnership with the Clinical Development physician
  • May provide input to, or participate in, meetings of an independent data monitoring committee (IDMC) or GSK internal safety review committee (iSRC)


Candidate Profile

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


Behavioural Competencies
  • Demonstrated track record of quality decision making and problem resolution based on assessment of all relevant supporting and conflicting information/factors and understanding of the wider context
  • Excellent leadership skills in the matrix team setting. Proven ability to train, coach and mentor
  • Ability to manage and co-ordinate tasks, projects and processes across a large organisation
  • Highly effective communication skills; able to present complex data to groups at all levels of the organisation and externally to GSK. Makes medical information/concepts accessible for non-physicians
  • Highly developed negotiating and influencing skills. Ability to influence others to make sound decisions from a medical point of view by providing clear medical information
  • Demonstrated ability to prioritise multiple tasks and deliver to deadline with high standard of quality
  • Contributes innovative ideas to address new issues or improve approaches to existing operations
  • Ability to adjust behaviours and priorities based on changing environment
  • Demonstrated ability to think tactically and strategically and take account of internal/external environment when considering safety issues and business processes
  • Ability to engage in, and contribute to, broad GSK environment with confidence, impact, integrity and professionalism


Core Competencies
  • Leadership capability - demonstrated ability to lead and inspire teams and develop and mentor individuals and allocate resource strategically and according to the portfolio priorities
  • Strategic Thinking - maintains competitive advantage by carefully considering the issues and competing priorities within a situation, program or portfolio and then developing a strategy that includes the strategic application of available principles, tools and systems
  • Business Acumen - Understands the implications of decisions related to human, financial, material and information resources, from a business perspective and uses this knowledge to plan, implement and manage clinical research within R&D
  • Project Management - Demonstrates the discipline of risk-based planning, organising and managing resources to bring about the successful completion of specific project goals and objectives in accordance with defined quality and time-based metrics


GSK Values

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.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, 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.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

Similar jobs

Similar jobs