As Sr. Clinical Development Director - Gastroenterology
, you will be the Clinical Development Lead (CDL) for a GI clinical program. You will lead the clinical team, with an opportunity to support multiple indications as part of this program's life cycle management plans. You will work as part of a cross-functional team to deliver on a high-priority program, while also contributing to a growing, dynamic, and collaborative Clinical Sciences community of physicians and scientists.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
- Generating the data and evidence required to determine a medicine's potential efficacy, safety profile, key areas of product differentiation, and value to patients
- Establishing expeditious clinical development timelines and incorporating key decision points and Go/No-Go criteria for the CDP
- Developing and maintaining relationships with program counterparts, including Research, Regulatory, Clinical Operations, Statistics, and Commercial
- Contributing to and partnering on the development of strategic initiatives, specific Business Development activities, and various organizational initiatives in Clinical Development
- Playing an active role in the technical and leadership development of Clinical Sciences staff via coaching and mentoring.
Scientific Leadership, Direction and Strategy:
- Employing visionary and 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 or a 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, positively interfacing with, and influencing across a diverse range of scientific external experts (e.g. regulators, payors, CROs, consultants, investigators) in order to deliver an integrated clinical development strategy, which aligns to the business strategy and achieves mutual goals related to patient need
- Integrating inputs from across disciplines (e.g., scientific, clinical, commercial, regulatory) to contribute to the Medicine Profile. Accountable for the clinical components of the Medicine Profile.
- Accountable for risk/benefit of the asset. Actively leading and making decisions that balance risk/benefit at the project level with clear understanding of impact on study/project indication approvals; taking action to mitigate risk where appropriate
- 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
- Accountable for the evaluation of clinical study/program probability of technical success (PTS)
Study & Program Design and Evidence Generation:
- Driving an end-to-end integrated clinical development strategy that is appropriately resourced to achieve regulatory approvals, reimbursable medicines, and successful lifecycle management
- Leading clinical development discussions at regulatory interactions; accountable for clinical components of regulatory submissions (i.e. IND, NDA, BLA, MAA), including briefing documents, presentations, addressing questions and responses
- Providing effective leadership support / oversight of evidence generation activities to ensure patient safety and study delivery
- Delivering value and access insights to inform medical strategy, expand market access, and address unmet patient need
Creating Innovative Scientific and Technical Solutions
Why you?Basic Qualifications:
- 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 and gaining stakeholder support; encouraging others to think differently and come up with business solutions
- MD, PhD, and/or PharmD degree
- Extensive clinical training and/or applicable clinical research experience; understanding of clinical development planning and running clinical trials from concept study idea to publication
- An understanding of the gastroenterology disease space, the underlying biology, and potential therapeutic targets, as well as current and future potential treatment options
- Demonstrated experience managing complex projects and working collaboratively with multiple stakeholders regarding new strategies to ensure consistent communication
- Robust knowledge of ICH guidelines, FDA requirements, regulatory and reimbursement data requirements in responsible area
- Solid understanding of needs and priorities of regulators, payers, and prescribers in relevant market(s)
- Significant years of experience leading line and matrix teams with a strong reputation of inspiring and motivating high performance
- 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
Why GSK?Uniting science, talent, and technology to get ahead of disease together
- Extensive experience in clinical drug development within the GI disease area
- Demonstrated experience integrating genetic data to inform and guide clinical protocols
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.
Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. Our R&D focus is to deliver a new generation of vaccines and medicines using thescience of the immune system, human genetics and advanced technologiesto get ahead of infectious diseases, HIV, cancer and other immune-mediated and respiratory diseases.We do all this with a commitment to operate responsibly for all our stakeholders by prioritisingInnovation, Performance and Trust.
Our bold ambitions for patients are reflected in new commitments to growth and a significant step-change in delivery over the next five years. This means more GSK vaccines and medicines, including innovative new products, will reach more people who need them than ever before.
We have long believed that building trust is key to stronger performance, helping to create value for shareholders, impact for patients and society and a reason outstanding people choose to work for and with us. That's why being a responsible business is an integral part of our strategy. Taking action on environmental, social and governance issues is a key driver in our strategy.
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.S o, if you share our ambition, join us at this exciting moment in our journey to get Ahead 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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.
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.
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