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Senior Clinical Development Director - Research Pipeline & Franchise Liaison Gastroenterology

Employer
GSK
Location
Collegeville, Pennsylvania; Philadelphia, Pennsylvania; Collegeville, Pennsylvania
Salary
Competitive
Closing date
Jun 29, 2022

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Clinical leader sought to provide late-stage development leadership and advice for luminal gastroenterology (GI) programs in research and clinical development at GSK. As Sr. Clinical Development Director - Research Pipeline & Franchise Liaison GI, you will be responsible for working with the Group Senior Director - GI to define and implement an integrative and efficient collaboration strategy with Research, early clinical as well as business development. You will work across the matrix to ensure a seamless and efficient portfolio transition into Clinical Development of both internal and external assets, while working with the Business Development Lead, Early Development Team and Discovery Medicine Leaders to define clinical development programs being accountable for the late stage development strategy. You will also collaborate with our Franchise partners to ensure optimal scientific understanding and presentation of the GI portfolio within GSK.

Job Purpose and Key Responsibilities:
  • Providing integrated and innovative clinical development strategy to support the creation and management of the Integrated Evidence Plan (IEP), including the Clinical Development Plan (CDP) for an asset in development
  • Strategic Leadership: Integrating scientific rationale, regulatory requirements, product development plan and commercial goals to optimize clinical study designs aligned with the IEP and CDP
  • Contributing to and partnering on the development of strategic initiatives, specific Business Development activities and various organizational initiatives in Clinical Development
  • Developing and maintaining relationships with program counterparts in Business Development, Commercial, Research, Regulatory, Clinical Operations and Statistics
  • Working with global medical affairs colleagues to organize scientific advisory boards to inform product development for GI disease(s)
  • Playing an active role in the technical and leadership development of Clinical Sciences staff via coaching and mentoring and potential direct line management


Scientific Leadership, Direction and Strategy:
  • Employing strategic thinking to provide expert leadership of disease/therapeutic area specific strategy for a drug(s) or program(s).
  • Leading selected clinical development projects for products/franchise of compounds
  • Serving as a clinical point of contact for senior management and senior level matrix teams, both internally and externally for an asset(s) in development
  • Leading and positively interfacing with and influencing across a diverse range of scientific external experts (e.g. regulators, payors, CROs, consultants, investigators) in order to deliver integrated clinical development strategy, which align to the business strategy and achieves mutual goals related to patient need
  • Integrating inputs from across disciplines (scientific, clinical commercial, regulatory) to contribute to the Medicine Profile. Accountable for the clinical components of the Medicine Profile.
  • Delivering value and access insights to inform medical strategy, expand market access and to address unmet patient need
  • Assessing and predicting when therapies designed for one patient population/indication can be used in alternative scenarios to broaden potential patient benefit
  • Anticipating problems and proactively seeking input from other teams/functional lines within R&D. Using scientific/operational expertise to solve study and/or project related problems
  • Determining the probability of technical success (PTS) for he clinical study/program


Creating Innovative Scientific and Technical Solutions:
  • Overcoming obstacles by experimenting with and adopting new ways of working including digital tools and technology
  • Championing implementation of innovative methods and processes within clinical development
  • Delivering value and access insights to inform medical strategy, expand market access and to address unmet patient need


Why you?

Basic Qualifications:
  • Bachelor's degree in a science related field
  • MD, PhD or PharmD degree
  • Extensive experience in Gastroenterology clinical drug development with an understanding of the disease, the underlying biology and potential therapeutic targets as well as current and future potential treatment options
  • Extensive clinical training and/or applicable clinical research experience; understanding of clinical development planning and running clinical trial from concept study idea to publication.
  • Demonstrated experience managing complex projects and working collaboratively with multiple stakeholders regarding new strategies to ensure consistent communication
  • Proven ability to maximize and integrate genetic data to advance disease understanding and inform and guide clinical development plans
  • Thorough understanding of clinical research methodology and biostatistics principles, to facilitate innovative and efficient clinical trial design, and clinical development plans with clear data-driven decision rules
  • Demonstrated experience using new learning and digital tools to create innovation in other areas
  • Expertise in inductive and deductive reasoning, statistics, and in providing mechanisms to interpret and analyze highly complex information including digital content


Preferred Qualifications:
  • Significant years of clinical experience in luminal gastroenterology
  • Significant years of experience leading line and matrix teams with a strong reputation of inspiring and motivating high performance


Why GSK?

At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Healthcare, strengthening our leadership, and transforming our commercial execution. Now, we're making the most significant changes we've made to our business in over 20 years. We're on track to separate and create two new companies in 2022: New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands. ​



With new ambition comes new purpose. For New GSK, this is to unite science, talent, and technology to get ahead of disease together - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive. ​



Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients - so we deliver what matters better and faster; accountable for impact - with clear ownership of goals and support to succeed; and where we do the right thing . So, if you're ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together. ​

#LI-GSK #LI-Hybrid #LI-Remote

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