Group Leader, Early Phase/CGT Team SERM
Site Name: USA - Pennsylvania - Upper Providence, USA - Massachusetts - Boston Posted Date: Sep 17 2021 Group Leader, Early Phase and Cell and Gene therapy team. This role is for either a Director (Scientist) or Medical Director (Physician) to act as a Group Leader, with management responsibilities including managing safety physicians and scientists across the US and UK sites. We are seeking a highly motivated individual as a Group Leader, Early Phase and Cell and Gene therapy team, within our Global Safety Department. This is a fantastic opportunity to utilise your pharmacovigilance knowledge and experience, to manage a team of physicians and scientists working in earlier phases of drug development. Along with management responsibilities, you will also contribute directly to assets by being Safety Lead for a number of early phase assets. Key aspects to this role include combining effective management, developing your team and leading the safety strategy for your assets, all working to ensure appropriate risk mitigation and ongoing benefit:risk evaluation for your own products and those of your team. You will be expected to drive discussions (and management) of safety issues, including presenting safety-related strategy or findings to senior stakeholders (such as Global Safety SVP/VP and Senior Leadership Teams) and to GSK's governance bodies. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following: Responsible for managing a team of scientific and medical staff within the Early Phase Group and supporting the EPG Team Leader to implement the strategies and action plans set forth by Pharma Safety Development and GCSP leadership teams. Line management responsibilities for staff and all projects in their team Responsible to work with other Group Managers to support the Team Leader to drive a flexible resourcing model by creating a tool for the team to enter workload and to ensure better planning. Responsible for ensuring that appropriate metrics are collected and compliance with processes. In conjunction with the Team Leader and other group managers identify remedial actions if metrics do not meet pre-specified targets. Responsible for training mentoring, coaching, and development of team members particularly ensuring training the new starters in Pharma Safety processes. May deputise for the Team Leader Provides high level expertise in the safety evaluation and risk management of key GSK assets or other highly complex products in clinical development 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 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. Accountable for ensuring that risk reduction strategies are included in relevant documents such as clinical study protocols and/or product labelling, as appropriate Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Qualified physician or equivalent BSc and PhD with extensive experience in safety Extensive knowledge of Early Phase safety and Oncology experience Experience leading and developing a team Extensive knowledge around processes required for early phase safety and experience in contributing to GSK workstreams to optimise safety related process Previous experience in managing a safety team, including mentoring and recruitment experience Sound therapy area knowledge across oncology and non-oncology therapy areas Expert evaluation skills and analytical thinking 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 other related disciplines, e.g. statistics, epidemiology relevant to assessing drug utilization and safety at the population level Clear understanding of clinical development process Preferred Qualifications: Experience across other therapy areas outside Oncology and Cell and gene therapy. BEHAVIOURAL COMPETENCIES: Excellent leadership skills in the matrix team setting. Proven ability to train, coach and mentor 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 Demonstrated ability to prioritise multiple tasks and deliver to deadline with high standard of quality Closing date 10th September. 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. Managing individual and team performance. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Implementing change initiatives and leading change. Sustaining energy and well-being, building resilience in teams. Continuously looking for opportunities to learn, build skills and share learning both internally and externally. Developing people and building a talent pipeline. Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation. Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally. Budgeting and forecasting, commercial and financial acumen. 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. 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