Senior Medical Director Clinical Development

Role Summary

Location: USA - Pennsylvania (Upper Providence) and USA - Massachusetts (Waltham). The position is Senior Medical Director, Clinical Development. You will lead clinical and scientific strategies for advanced-stage assets in immunology and fibrosis, shaping treatments for complex diseases. You will provide clinical and scientific leadership for potential new, established, and emerging indications, and work with medicine teams to plan and assure delivery of clinical research and development activities, including planning development programs and enabling seamless transition from early to late phase.

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

Qualifications

• Required: Medical degree and clinical medical specialty board qualification in Rheumatology or Allergy/Immunology.
• Required: Experience in (bio-)pharmaceutical industry with experience in Rheumatology or Immunology clinical drug development.
• Required: Experience with planning clinical development for a Rheumatology or Immunology asset and/or indication.
• Required: Experience in drug development, including Phase 2 and Phase 3 clinical trial design, initiation, execution, and closure.
• Required: Experience of global regulatory filings/submission.
• Required: Experience of immunologic-mediated diseases, underlying biology, and potential therapeutic targets.
• Preferred: Deep experience in Rheumatology, Autoimmune, or the Neuroinflammation space.
• Preferred: Solid understanding of needs and priorities of regulators, payers, and prescribers in relevant global market(s).
• Preferred: Experience collaborating with multiple stakeholders on complex projects.
• Preferred: Record of building and maintaining strong relationships with internal and external stakeholders.

Additional Requirements

• On-site presence (minimum two days per week) at one of GSK’s US sites (Upper Providence, PA or Waltham, MA).