Director / Therapy Area Head of Programming
- Collegeville, PA
Site Name: UK - Hertfordshire - Stevenage, USA - Pennsylvania - Upper Providence, UK - London - Brentford
Posted Date: Oct 27 2020
Are you a visionary leader? Are you a strategic thinker? Do you want to drive change in how clinical programming influences drug delivery? The Therapeutic Area (TA) programming head is the perfect opportunity to provide that leadership, influence and drive change in support of the Clinical Programming vision. Two high-profile TA head roles reporting to the Head of Development, Programming for HIV or Hep/GI & Speciality disease clusters are open for recruitment. Each will provide global supervision of a disease cluster and be part of the Development programming leadership team. Exceptional management skills are critical to supervise a large portfolio of work and grow and develop a collaborative programming team in line with the clinical programming vision.
You need to be an influential, visionary and strong technical leader providing innovation and operational excellence with a broad knowledge of the complexities to report and submit clinical trials. You will also need to be strategic in the use of internal and external resource and provide oversight to ensure that programming asset teams execute and deliver in a way that optimizes, expedites and delivers high quality in support of regulatory submissions, health authority assessments, safety updates and publications.
- Provide portfolio stewardship for groups of programmers aligned with specific business areas across Pharmaceutical R&D, providing end-to end programming oversight from Discovery through to development and commercialisation
- Champion and drive innovation, through critical assessment, implementation and/or development of novel processes and technologies
- Ensure the Clinical Programming department drives operational excellence, data strategy and the technical landscape by providing innovative solutions to support drug delivery
- Accountable for steering the high-quality execution of clinical trial data and submissions, planning the resource strategy and ownership for quality and CRO governance
- Effectively manage budgets to ensure cost effective solutions are in place for optimal delivery
- Provide state-of-the-art programming knowledge to clinical projects and other strategic efforts within the broader organization, and serves as a contact and advocate for the programming function in supporting cross-functional/therapeutic area objectives
- Anticipate and drive the change process to enhance organizational capability and efficiency
- Demonstrate governance and guide the department to ensure Biostatistics SOPs meet current regulatory expectations and are fit for purpose
- Safe guard compliance with GSK policies and procedures and make sure that all aspects of their group's conduct are aligned with GSK's integrity principles
- Nurture the capability of the broader programming organisation, promoting and fostering a culture for technical innovation and operational accountability.
- Develop, support, coach and empower staff and teams to contribute to and collaborate to achieve the success of the Clinical Programming vision
- Manage all Clinical Programming staff and contingent workers aligned with the business unit and partner effectively with centrally managed resource groups as required.
- Sponsor/guide efforts to deliver and embed initiatives, standards, capabilities, and strategies within the broader Therapeutic Area functions
- Influential in supporting cross-functional/therapeutic area decision-making for the broader Biostatistics organization
- Guide approaches taken using technical expertise and sound judgement in determining appropriate risk and strategy for issues of high complexity and/or major business impact
- Adept at managing up through the organisation the emergence and resolution of significant project issues
- Recommend, influence and negotiate clear strategies for large areas of the business with broad implications including regulatory and clinical development
- Consider alternatives, assimilate information/opinions quickly in discussions up to functional level and adapt approach for optimal situational response or outcome
- Develop and utilise a wide network throughout GSK and with outsourced partners to encourage collaborations across departments and divisions (internationally and multi-disciplinary groups)
Basic Qualifications & Experience:
- Bachelors degree or higher in a scientific or technical discipline with demonstrated extensive (and in-depth) practical or proven experience at the expert level
- Will have supported several therapeutic areas and/or have supported all phases of drug development in highly accountable roles
- Experience leading teams and / or multi-disciplinary project teams as a direct manager
- Strong knowledge of medicine development strategies and processes formed by deep development experience
Preferred Qualifications & Experience:
- Strong knowledge of the programming, regulatory and therapeutic landscapes
- Proven record of being able to influence internal and external stakeholders on challenging medicine development, reimbursement and product-stewardship issues
- Able to operate effectively in a range of external settings, such as working with co-development partners, consulting with external experts or representing GSK at high-profile regulatory meetings
- Lead, or make major contributions to, the development of innovation initiatives or other long-term business strategies with a broad remit (across R&D or industry wide) and gain stakeholder approval
- Apply creative thinking/business analysis skills and assess new developments to improve or solve business problems
- Effective communication and influencing skills at all levels, including VP to influence and embed positive change within own department and across partner departments and functions
- Demonstrate effectiveness in building, managing and leveraging networks/client relationships internally and externally
- Business Acumen - Understands implications of decisions from a broad business perspective and uses this knowledge to influence strategic direction at the highest levels of R&D
- Ideally will have external technical presence and at minimum will have good all-round knowledge of the broader technical landscape as applied to medicines development
- Proven competency of communication and influencing skills with key external experts and stakeholders (such as consultants, therapeutic area experts and regulators)
At GSK, our mission is to improve the quality of human life by enabling people to do more, feel better and live longer. Our three world-leading businesses research and deliver innovative medicines, vaccines and consumer healthcare products. We need a talented and motivated workforce to deliver against our strategy. To achieve this, we strive to attract the best people and to create an environment that empowers and inspires.
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