Senior Medical Director, Immunology

Merck•Billerica, MA

7d•Hybrid

About The Position

This role provides medical leadership across rheumatology/immunology clinical development programs with scientific rigor and a patient-centric focus. The Senior Medical Director will lead clinical development planning, contributing to target product profiles, indication strategy, and evidence plans. They will drive protocol development, oversee execution, and document decisions with rationale, risks, and mitigations. Collaboration across Clinical Ops, Safety, Biostatistics, Regulatory, Quality, Medical Affairs, and Market Access is essential for integrated delivery. The role also involves supporting regulatory interactions and communicating results through CSRs, publications, and external forums. Additionally, the Senior Medical Director will engage KOLs compliantly and provide matrix leadership, mentoring as needed.

Requirements

Medical Degree (MD) or international equivalent; board cert preferred
5–7+ years Rheumatology/Clinical Immunology experience; hands-on patient care
5+ years medical leadership in pharma/biotech clinical development
Proven ability to design development plans and lead global trials in a matrix
Strong GCP/ICH knowledge; familiarity with FDA/EMA requirements
Excellent cross-functional leadership and communication skills
Track record delivering milestones under tight timelines
Ability to work at a computer for extended periods (reading/writing/reviewing documents, virtual meetings).
Ability to communicate effectively verbally and in writing.
Ability to travel as required (including navigating airports/hotels/sites).
Ability to attend in-person and virtual meetings, including occasional early/late meetings across time zones.

Responsibilities

Provide medical leadership across rheumatology/immunology clinical development programs with scientific rigor and patient-centric focus.
Lead clinical development planning, contributing to target product profiles, indication strategy, and evidence plans.
Drive protocol development, oversee execution, and document decisions with rationale, risks, and mitigations.
Collaborate across Clinical Ops, Safety, Biostatistics, Regulatory, Quality, Medical Affairs, and Market Access to ensure integrated delivery.
Support regulatory interactions and communicate results through CSRs, publications, and external forums.
Engage KOLs compliantly and provide matrix leadership, mentoring as needed.