Study Strategic Planning Lead

Study Strategic Planning Lead (Associate Director)

As R&D efforts follow science without constraint, we need to take full advantage of our internal data and expertise, as well as leverage solutions and technology, to inform, optimize and validate our clinical trial protocols and study delivery plans.

The Study Strategic Planning Lead will support study teams in creating optimal clinical trials plans that deliver on the asset and study strategy. These plans will be driven by the analysis of internal and external data, and the inclusion of the necessary Digital Health and other recruitment levers to accelerate patient enrolment and meet patient diversity targets. The SSPL is responsible for advising on data-driven actionable intelligence and high quality insights, partnering with internal discipline experts and study team members. This role will project manage a team of experts and will also directly guide, advise and support upon clinical operations planning activities.

Key Responsibilities include, but are not limited to:

• Partner with the study teams (Clinical Scientist, Central Monitoring Lead, COAL, SDL, and LDL) within the existing Clinical Delivery Plan (CDP) processes, to provide value driven clinical trial solutions and data informed approaches to the clinical operational plan
• Advise upon the actionable intelligence generated from current and emerging data sources on clinical trials at a global, country and a site level and relate to study budget
• Understand the impact and value of clinical trial solutions (digital [eCOA, ePRO, mobile nursing, DTP, Telemedicine, etc.] and Patient Engagement/Recruitment solutions) to de-risk, optimize and enhance investigator and patient experience within clinical trials and relate ROI to study budget, leading to engaging Digital and PRE SMEs to advise on available solutions
• Resourcing request lead for the feasibility analytics, modelling, clinical budgeting and other expert colleagues
• Oversight responsibilities for timely, high-quality deliverables (e.g. recruitment plans, feasibility report) to clinical trial teams to support the clinical trial planning
• Maintain information and KPIs on strategic approaches, solutions and feedback on impact and successes
• Identify and share trial informatics best practice and exemplars within Clinical Operations.
• Driving the assessment, piloting and embedding of new data analytics and data sources to ensure GSK continues to access best in class solutions.
• May act as Subject Matter Expert or System Business Owner for tools and systems
• Maintain information on impact and successes
• Provide mentoring and coaching to junior members of staff

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Bachelor's degree in relevant field
• 7+ years relevant industry experience
• Leadership experience in a clinical development operations or study feasibility role at a CRO, pharmaceutical company or other relevant environment

Preferred skills:

• Master's or PhD degree in relevant field
• Proven track record in driving strategies for clinical trials, diversity & inclusivity, digital and patient engagement action plans or solutions
• Excellent problem solving and project management skills gained in a complex matrix organization
• Results orientated with a drive to set and reach challenging goals with high standards for performance
• Excellent influencing and negotiation skills
• Excellent written and verbal communication skills
• Ability to build strong relationships
• Ability to analyze data from divergent sources and translate it into meaningful recommendations
• Good understanding of the drug development process
• Understanding of all relevant industry guidelines (ie; FDA, GCP and ICH guidelines)
• Experience utilizing clinical trial recruitment modelling tools
• Experience utilizing industry clinical trial related data sources (i.e., CiteLine, DQS, TriNetX, etc.)
• Experience across therapeutic areas would be advantageous
• Experience with data manipulation, visualization, or advanced analytics
• High level of proficiency with Microsoft Office

#LI-GSK

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

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 organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

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 place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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