Senior Medical Director, Immunology

Merck•Billerica, MA

9h•Hybrid

About The Position

This role is for a Senior Medical Director in Immunology at EMD Serono, a Healthcare company focused on Oncology, Neurology, and Fertility. The position involves providing medical leadership for clinical development programs, ensuring scientific rigor and patient-centric development. The company emphasizes innovation, diversity, inclusion, and personal development. This role requires the candidate to be eligible to work in the US without sponsorship.

Requirements

Medical Degree (MD) or international equivalent
Board Certification in Rheumatology and/or Clinical Immunology and/or advanced degree (MD/PhD)
Significant clinical experience in Rheumatology and/or Clinical Immunology (typically 5–7+ years), including prior hands-on patient care
5+ years medical leadership in pharmaceutical/biotech clinical development, including regulatory submissions and interactions (FDA/EMA/others)
Experience designing clinical development plans and leading global clinical trial execution in a matrix environment
Strong track record of delivering milestones under tight timelines
Deep knowledge of drug development and clinical trial methodology in immune-mediated inflammatory diseases/rheumatology
Strong understanding of GCP, ICH, FDA/EMA requirements
Sound clinical judgment and ability to make decisions with incomplete/ambiguous data; clearly communicates rationale and trade-offs
Excellent cross-functional leadership, stakeholder management, and influence without authority
Strong medical writing and document review skills (protocols, IBs, CSRs, briefing books)
Excellent communication and presentation skills for governance and external forums
Willingness to travel as needed (domestic/international)
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, ensuring scientific rigor and patient-centric development.
Lead clinical development planning and contribute to target product profile, indication strategy, and evidence generation plans.
Drive protocol development and medical oversight through execution (population, endpoints, dosing rationale, safety monitoring, biomarkers as applicable).
Lead governance preparation and decision-making, documenting recommendations, rationale, key risks, and mitigation/contingency plans.
Partner cross-functionally (Clinical Operations, Safety, Biostats, Regulatory, Quality, Medical Affairs, Business Franchise) to ensure integrated strategy and high-quality delivery.
Support regulatory submissions and interactions (briefing packages, responses, meeting participation) as medical lead.
Interpret clinical data and communicate results via CSRs, publications, congress materials, and internal updates.
Engage external experts (investigators/KOLs) compliantly to inform scientific strategy and study design.
Provide matrix leadership and mentoring; may manage direct reports depending on organizational needs.
Matrix leadership across global cross-functional teams.
Talent development: mentoring and coaching Clinical Scientists/medical staff; direct reports may be included based on organization needs.