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Executive Director - MIDD Lead​

Stevenage

Job Type

Job Function

Science and Technology

Location

Stevenage

On-Site or Remote

Job Type

Salary

Competitive salary and benefits

About the Role

*Job description* *Site Name:* UK - Hertfordshire - Stevenage, Home Worker - GBR, Home Worker - USA, USA - Pennsylvania - Upper Providence *Posted Date:* Jan 19 2024 *Executive Director, MIDD Innovation Lead* Are you interested in a highly visible, crucial role operating at the highest level of R&D that allows you to partner with senior leaders from across the organisation and lead, collaborate and influence across a dynamic internal environment while representing GSK globally? *Job Purpose* Reporting directly to the VP, Clinical Pharmacology Modelling and Simulation (CPMS), this role will lead the evolution and application of the Model Informed Drug Development (MIDD) strategy across GSK, enabling its further integration into the broader R&D data strategy and disease level strategies. The Executive Director, MIDD innovation lead will manage and optimise the global CPMS strategic MIDD project planning process, including provision of expert review and advice, development of good practices, efficient processes, and an effective operating model. You will lead or co-lead with respect to above disease level strategic MIDD initiatives with respect to ensuring MIDD activities are effectively integrated and optimally aligned. The role aligns with the growth in the influence of MIDD approaches with respect to drug development and regulatory decision making, with the latter being fostered by the expected emergence of an ICH MIDD guideline and its focus on enabling standardisation of MIDD Evidence assessment. In this regard, MIDD enabled acceleration strategies to reduce cycle times and deliver simultaneous global submissions to “upper quartile” timelines for key markets are central to GSK’s ambition for patients. Key aspects of role includes, i) overarching internal alignment of MIDD strategic planning, implementation and streamlined delivery with internal initiatives including but limited to increased focus on maximising our return on investment in internal and external data access & integration, automated analytical & reporting solutions, and end to end disease level planning ii) Aligning general internal MIDD project level planning within context of individual CDPs and IEPs, ensuring via development of appropriate review processes that strategy is tailored to the key development questions, the potential internal and regulatory impact is assessed so that the appropriate level of stakeholder, governance and regulatory authority alignment is achieved in advance of key milestones and that the agreed workplan is implemented with respect to our one global CPMS operating model iii) Influence and lead change with respect to i) and ii) working with CPMS TA and Asia hub heads, who are accountable for individual project deliverables, to implement overall general strategy, good practices and agreed general expectations (as aligned with CPMS head and LT). Act as an independent MIDD expert to ensure consistency and standardisation across global CPMS. IV) Work on internal and external cross-functional leadership teams with respect to i) and ii) across the data, analytics, reporting , regulatory and payer engagement continuum *Key Responsibilities:* - Act as an advocate for the value of model-informed decision-making in drug development, educating GSK in what is happening externally and what is possible now and in the future through early and open collaboration. - Be the go-to organizational independent expert in MIDD providing expert guidance to Senior leadership and review committees (RRB, DRB) to supplementing input from by TA and Asia hub heads - Accountable for enabling the strategic direction of the MIDD aspects of global CPMS strategy with respect to - developing, implementing, and practicing against standards and processes to enable the efficient technical aspects of the planning, review and alignment on focused plans - Ensuring appropriate end to end implementation – Working with CPMS head of lifecycle management to bring late stage thinking in terms Quantitative Benefit Risk and cost effectiveness analysis, RWE and epidemiological evidence as a subject matter expert on MIDD. Coach, train and develop other MIDD specialists and CPMS generalists - Organize and act as secretariat for the MIDD review forum, evolving the forum based on learnings and changing needs. - (co-) Lead along with CPMS leadership and other CPMS & associated line subject matter experts the MIDD GSK strategy in terms of further development of capabilities in terms of Tools, systems and business processes - Lead longer term strategic initiatives in the development of innovative MIDD solutions to complex R&D problems - As a CMPS MIDD expert work with other global functions –Regulatory (internal), Biostatistics, Clinical, Commercial, DMPK, Imaging, Discovery Medicine, Research Units and Development with respect to aligning MIDD strategies with respect to general overarching strategies and deliverables from other groups. - Maintain a thorough understanding of appropriate regulatory (FDA, EMA, CDE and PMDA) and ICH guidelines across major markets in the design of clinical studies and drug development strategy with particular emphasis on the role of MIDD. - In line with the evolving regulatory landscape with respect to greater acceptance of MIDD approaches, lead regarding adoption of innovative model based design and analysis approaches . *Why You?* *Basic Qualifications:* - PhD or equivalent in Clinical Pharmacology, Pharmacometrics - Industry experience in a Senior Director role and successful implementation of MIDD approaches to accelerate patient access to novel therapies and to expand therapeutic indications of marketed drugs, including innovation in the regulatory space - Experience in complex modelling approaches and applications, with solid understanding of the scientific, clinical, operational and regulatory aspects of clinical pharmacology - Proven track record of developing training (students or colleagues), influential publications, and contributions (or scientific leadership) within associated communities (e.g. ISOP, PAGE ,PAGANZ, etc) and Journals within the associated fields, with the willingness to continue your external influencing role with respect to your general interests and the greater acceptance of MIDD with respect to its use in R&D, regulatory submissions, health technology assessment and clinical practice - Matrix leadership experience and strategic resource management skills *Preferred Qualifications:* - Complex problem-solving skills with limited information available to make strategic decisions and interpretations. Anticipates long-term future issues - Credibility, networking & influencing skills in the clinical pharmacology community - Able to work in a multicultural setting across different time zones *Why Us?* GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce. 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 neurodiversity, 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. 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