Senior Medical Director Clinical Development

Are you driven by the opportunity to lead clinical and scientific strategies for advanced-stage assets in immunology and fibrosis, shaping the future of treatments for complex diseases? If so, the Senior Medical Director, Clinical Development role could be an exciting opportunity to explore.

GSK seeks a Senior Medical Director, Clinical Development to provide clinical and scientific leadership for potential new, established, and emerging indications for advanced stage assets in the immunology and fibrosis portfolio.

The Senior Medical Director, Clinical Development will work with medicine teams to plan and assure delivery of clinical research and development activities. As well as working with early development teams to plan clinical development programs and establish efficient collaboration enabling seamless transition from early to late phase of development.

PLEASE NOTE: This career opportunity requires an on-site office presence (minimum of two days a week) at one of GSK’s US (Upper Providence, PA or Waltham, MA) sites.

Key Responsibilities:

• Lead the end-to-end clinical development strategy for a drug or program. Manage specific clinical development plans for product(s) and/or indication(s) in specific therapy/disease areas.
• Oversee Integrated Evidence Plan (IEP), Clinical Development Plan (CDP) and its component clinical trials; be accountable for clinical aspects of Target Medicine Profile (TMP).
• Provide strategic leadership, for example in assuring that the clinical study designs are aligned with the IEP and CDP, and consider the scientific rationale, regulatory requirements, product development plan and commercial goals
• Establish and deliver clinical development timelines, enabling key decision points and Go/No Go criteria for the CDP
• Collaborate with internal teams (Commercial, Research, Regulatory, Clinical Operations, Statistics etc.) and act as the clinical point of contact for senior management.
• Contribute to the strategic and organizational initiatives in Clinical Development, along with Business Development activities, including due diligence projects
• Build and manage external relationships with a range of scientific external experts to align clinical programs with business strategy and patient needs.
• Assess and mitigate risks, evaluate technical success probabilities, and identify transformational opportunities with significant patient benefits.
• Contribute to global regulatory submissions and interactions, including briefing documents and responses.
• Champion implementation of innovative methods and processes within clinical development and gain stakeholder support; encourages others to think differently and produce business solutions

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Basic Qualifications:

• Medical degree and clinical medical specialty board qualification in Rheumatology or Allergy/Immunology.  
• Experience in (bio-)pharmaceutical industry with experience in Rheumatology or Immunology clinical drug development.
• Experience with planning clinical development for a Rheumatology or Immunology asset and/or indication.
• Experience in drug development, including Phase 2 and Phase 3 clinical trial design, initiation, execution, and closure. 
• Experience of global regulatory filings/submission.
• Experience of immunologic-mediated diseases, underlying biology, and potential therapeutic targets.

Preferred Qualifications:

• Deep experience in Rheumatology, Autoimmune, or the Neuroinflammation space.
• Solid understanding of needs and priorities of regulators, payers, and prescribers in relevant global market(s).
• Experience collaborating with multiple stakeholders on complex projects.
• Record of building and maintaining strong relationships with internal and external stakeholders.

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 purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

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GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

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