Senior Director Clinical Development

Job description

Site Name: UK - London - Brentford
Posted Date: Feb 19 2024

Are you a senior pharmaceutical immunology physician, driven by clinical innovation and the desire to impact the lives of patients across the globe? If so, this position may be of interest.

A Senior Director, Clinical Development is sought to provide clinical and scientific leadership to the immunology franchise including emerging indications and adjacencies. You will work with project teams to plan and assure delivery of clinical research and development activities. You will work with late development teams to plan clinical development programs and facilitate close collaboration between Research and Development.

Key Responsibilities in Detail

• Lead matrix team of senior clinicians and clinical scientists with responsibilities for Dermatology and adjacent indications clinical development programs. Support technical and leadership development of Clinical Sciences staff via direct line management, mentoring and coaching.
• Identify and highlight acceleration, innovation, and transformational opportunities where projects can offer highly significant benefit to patients.
• Champion implementation of innovative methods and processes within clinical development and gain stakeholder support; encourage others to think differently and come up with business solutions. Oversee the strategic management of the Integrated Evidence Plan (IEP), including oversight of the Clinical Development Plan (CDP) and its component clinical trials for those assets in development under your leadership. Provide strategic leadership in designing the CDPs and IEPs, and then, for example in assuring that clinical study protocol designs are aligned with the IEP and CDP, and consider the scientific rationale, regulatory requirements, product development plan and commercial goals.
• Develop and maintain relationships with corporate counterparts in Commercial, Early Development, Research, Regulatory Affairs, Clinical Operations, Biostatistics, and other groups.
• Oversee clinical aspects of Business Development activities, including due diligence projects.
• Serve as a clinical point of contact for senior management and senior level matrix teams.
• Interface with and influence a range of scientific external experts (e.g., regulators, payors, CROs, consultants, investigators) to deliver clinical programs that align to business strategy and address patient needs
• Identify and highlight acceleration and value-finding opportunities where projects can offer highly significant benefit to patients.
• Assess risk/benefit at the study and/or project level. Take action to mitigate risk where appropriate.
• Make substantial contributions to regulatory interactions, including briefing documents, presentations, submission documents, and responses to questions.

Candidate Profile

Basic Qualifications:

• Doctor of Medicine or MD, PhD with Board Qualification (or Registration)
• Clinical and scientific leadership to immunology franchise

Qualifications & Preferable Expertise

• MD, preferably with an additional PhD/MSc or PharmD degree
• Dermatology experience preferable
• Filing experience strongly preferred
• Experience with designing, leading, and driving clinical development for an asset and/or indication or franchise.
• Experience with delivery of clinical trials and projects.
• Experience with clinical research methodology and principles of biostatistics to facilitate accelerated, innovative and efficient designs of clinical trials and clinical development plans with clear data-driven decision rules
• People management, coaching, mentoring and development experience. Experience leading line and matrix teams with a track record of inspiring and motivating high performance
• Experienced leader, with ability to inspire high performance from cross-functional teams
• Track record of building and maintaining strong relationships with internal and external stakeholders
• Robust knowledge of ICH and GCP guidelines, regulatory and reimbursement data requirements
• Solid understanding of needs and priorities of regulators, payers, and prescribers in relevant market(s)

Why Us?

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 organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

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.

As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class*(*US only).

We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on [email protected] or 0808 234 4391.

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