SERM Head

Standort: USA - Pennsylvania - Upper Providence Datum: Aug 31 2022 Are you a safety/pharmacovigilance physician with in-depth and hands-on experience, looking to lead and develop a great team? Reporting to the Vice President, Oncology/Immunology/Early Phase SERM, the SERM Head is responsible for providing pharmacovigilance and risk management expertise in overseeing the benefit-risk strategy for a critical portfolio of therapies. The individual will lead and mentor a team of safety physicians and scientists assigned to the portfolio and be responsible for direct management of the team. The SERM Head must demonstrate agility, ability to prioritize, and capability to function at a high level with cross-functional leaders, and must also be able to engage with development partners. This person must be experienced working in a matrix environment to advance the safety and biological understanding of compounds throughout the life cycle. The individual who assumes this position will interact with multiple levels of management within GSK and with external stakeholders, and is expected to be able to influence the strategic direction of complex issues for the assigned portfolio. As SERM Head, a typical day might include: – Leading and overseeing safety and risk management activities for clinical development and marketed products within the portfolio, including submission activities – Managing and developing a team of direct and indirect reports of safety physicians and scientists – Ensuring key safety documents and deliverables (e.g., safety-related sections of clinical protocols, ICFs and CSRs, signal assessment reports, reference safety information, aggregate reports, regulatory submissions and responses, safety content for internal and external communications) meet standards of quality and timeliness – Serving as primary point of contact for all patient safety-related activities, or supporting the Safety Lead in his/her role in this capacity – Providing direction and strategy on process improvements, individual and team interactions and overall SERM efficiency – Engaging as an active member of the Oncology/Immunology/Early Phase Leadership team GSK considers the clinical safety of its products to be of paramount importance. The person who assumes this role must be a confident leader, with strong medical and pharmacovigilance knowledge who is able to formulate and support benefit/risk assessments with a collaborative approach in a matrixed working environment. Key Responsibilities – Lead the medical and scientific staff within Safety Evaluation & Risk Management (SERM) – Define and drive the strategy and vision of SERM in alignment with business strategies, increased efficiency and effectiveness to meet the needs of the PV systems and development pipeline – Create and build an organization to train and recruit leaders to drive the practice and science of pharmacovigilance, participating as a leader in SERM governance – Coordinate medical and scientific SERM activities and resource projects, process initiatives and due diligence activities, providing adequate management and ensuring development of SERM staff – Serve as a member of the Oncology/Immunology/Early Phase SERM Leadership Team – Actively manage and evaluate risks associated with assigned GSK products, be accountable for the development of benefit/risk assessments for those products, and accordingly, make recommendations for the management and communication of the risks – Ensure adverse event documentation and follow-up processes are in compliance with legal and regulatory statues for all products – Maintain that the signal evaluation process is customized and managed in order to maximize its accuracy and efficiency – Monitor the safety profile of development and licensed products based on all sources and in collaboration with other departments, and translate this monitoring into appropriate safety risk management activities (including risk minimization activities and REMS, if needed) and labelling – Participate in the management of Reference Safety Information and aggregate safety document reviews/revisions; complete all tasks as assigned to this role as per GSK SOPs – Liaise with Legal, Regulatory and Medical Affairs departments regarding provision of medical expertise concerning reported adverse events, adequacy of information in promotional material fair balance statements, and development and conduct of clinical trials as it relates to the management of safety data – Participate and attend all relevant meetings/educational seminars to ensure that knowledge of pertinent medical or pharmacovigilance issues are up to date – Function as Safety Lead for one or more products, or as delegate for VP, Oncology/Immunology/Early Phase SERM, as needed – Forecast resource needs according to prioritization of programs within portfolio, and ensure resources are appropriate to achieve business objectives – Keep upper management informed of key benefit-risk inflections for assigned portfolio – Supervise preparation of materials for, and supporting presentation by team, to the Global Safety Board – Develop and maintain relationships with other leaders in Global Safety and cross-functional teams – Perform and/or oversee business development evaluations and recommendations from the patient safety perspective – Represent or Global Safety as a technical expert at external meetings, DSMB, or regulatory authority meetings Complexity Due to the universal application of safety at all levels of drug discovery, development and life cycle management and therefore, its impact on the overall portfolio, sales and growth of GSK products, the role has the potential to work: – Across the Preclinical R&D, Clinical R&D, Regulatory, and Commercial matrix environments – Across product pipeline in development and marketed products – With other SERM Heads, Heads of other SERM Therapeutic Areas, the Head of Global Safety as well as the EU-QPPV – With external development partners Management of global safety teams includes the following: – People management, recruiting, training, development and retention of high calibre staff – Aligning regional with global objectives – Compliance with internal policies, processes and external regulations – Forecasting resource needs and resource allocation across groups and sites   You are a proven leader and strive on developing, executing and advancing a strategic and successful benefit-risk program for a portfolio of products. You have experience managing high performing teams working in a matrix environment, providing the necessary guidance and mentoring for all to reach their goals Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: MD, (with board certification) DO, or its equivalent; and sub-speciality training highly preferred. Prior clinical medical practice experience is highly recommended. Significant relevant pharmaceutical industry experience with a successful track record in in safety and risk management and leading a global team is required Track record in leading global product submissions is required Must have a strong understanding of FDA, EMA and other Health Agency regulations Extensive knowledge and understanding of PV deliverables, standards and processes at a global level Additional experience in Pharmaceutical Medicine (Drug Discovery, Drug Development, Medical Affairs, Medical Information) is a significant asset and highly desired. Ability to navigate across a matrixed environment People management experience is required Excellent written and oral communication skills Strong scientific acumen and the ability to work in a dynamic matrixed environment with the ability to prioritize are key traits for an individual in this role 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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