Executive Director - MIDD Lead​

Job description

Nombre del sítio: UK - Hertfordshire - Stevenage, Home Worker - GBR, Home Worker - USA, USA - Pennsylvania - Upper Providence
Fecha de publicación: 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

Como empresa impulsada por nuestros valores de enfoque al paciente, transparencia, respeto e integridad, sabemos que la inclusión y la diversidad son esenciales para que podamos tener éxito. Queremos que todos nuestros colegas prosperen en GSK, brindando sus experiencias únicas, asegurándonos de que se sientan bien y que sigan creciendo en sus carreras.  Como candidato para un papel, queremos que usted se sienta de la misma manera.

Creemos en una cultura de trabajo ágil para todos nuestros roles. Si la flexibilidad es importante para usted, lo alentamos a explorar con nuestro equipo de contratación cuáles son las oportunidades.

No dude en ponerse en contacto con nosotros si desea analizar cualquier ajuste a nuestro proceso que pueda ayudarlo a demostrar sus fortalezas y capacidades.  Puede llamarnos al 0808 234 4391 o enviar un correo electrónico Ukdiversity.recruitment@gsk.com .   

A medida que lo solicite, le pediremos que comparta alguna información personal que sea voluntaria. Esto se utilizará para ayudarnos a comprender qué tan bien estamos haciendo frente a nuestras ambiciones de inclusión y diversidad. Realmente lo agradeceríamos si pudiera tomarse unos momentos para completarlo. Tenga la seguridad de que los gerentes de contratación no tienen acceso a esta información, no se utiliza en ninguna parte del proceso de selección y trataremos su información de forma confidencial y la utilizaremos de forma anónima.