Senior Medical Director, Clinical Development - Rheumatology/Immunology

Role Summary

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. Lead clinical and scientific strategies for immunology and fibrosis assets; plan and assure delivery of clinical research and development activities; collaborate with early development teams to plan programs and enable seamless transition from early to late phase. On-site presence required (minimum two days per week) at a US site (Upper Providence, PA or Waltham, MA).

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).
• Oversee Integrated Evidence Plan (IEP), Clinical Development Plan (CDP) and its component trials; accountable for clinical aspects of Target Medicine Profile (TMP).
• Provide strategic leadership to ensure study designs align with the IEP and CDP, considering 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 and serve as the clinical point of contact for senior management.
• Contribute to strategic and organizational Clinical Development initiatives, including due diligence for Business Development activities.
• Build and manage external relationships with scientific experts to align clinical programs with business strategy and patient needs.
• Assess and mitigate risks, evaluate probabilities of success, and identify opportunities with significant patient benefits.
• Contribute to global regulatory submissions and interactions, including briefing documents and responses.
• Champion innovative methods and processes within clinical development and promote stakeholder support.

Qualifications

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

Preferred Qualifications:
• Deep experience in Rheumatology, Autoimmune, or Neuroinflammation space.
• Understanding of regulators', payers', and prescribers' needs in global markets.
• Experience collaborating with multiple stakeholders on complex projects; strong relationship-building skills with internal and external stakeholders.

Skills

• Strategic clinical development leadership
• Program and trial design for Phase 2/3
• Regulatory submissions and interactions
• Cross-functional collaboration and stakeholder management
• Risk assessment and management, clinical program prioritization

Education

• Medical degree; specialty board qualification in Rheumatology or Allergy/Immunology