Job Title: Associate Medical Director/ Medical Director

Work Location: Suffolk County, Massachusetts

Summary:

The Associate Medical Director/Medical Director will be responsible for guiding clinical development strategy and execution for pipeline programs, requiring expertise in clinical research, regulatory requirements, and cross-functional collaboration. This role is ideal for a strategic thinker with a strong background in clinical development and a passion for advancing innovative medical solutions.

Responsibilities:

• Lead the design, oversight, and execution of clinical trials, including protocol development and data analysis.
• Collaborate with multidisciplinary teams to develop and implement clinical strategies aligned with organizational goals.
• Provide medical and scientific expertise for clinical trial protocols, study reports, and regulatory documentation.
• Ensure all clinical activities comply with regulatory requirements and Good Clinical Practice (GCP) standards.
• Serve as the primary medical contact for clinical sites, investigators, and external medical experts.
• Analyze and interpret clinical data to inform recommendations for program advancement or modification.
• Foster a collaborative and innovative environment that promotes scientific excellence and teamwork.
• Build and maintain relationships with key opinion leaders, healthcare professionals, and clinical investigators.

Qualifications:

• MD or equivalent degree with board certification in a relevant medical specialty; rheumatology experience is required.
• 2–4 years of clinical development experience in the biotechnology or pharmaceutical industry, or equivalent academic clinical rheumatology experience with experience as PI/sub-I in rheumatology/immunology studies.
• Proven track record in designing and executing successful clinical trials.
• In-depth knowledge of regulatory requirements and guidelines (FDA, EMA, etc.).
• Strong leadership, communication, and interpersonal skills.
• Ability to work effectively in a fast-paced, innovative, and collaborative environment.
• Strategic thinker with a passion for advancing medical science and improving patient care.
• Experience in early-stage biotech companies or startups is a plus.
• Background in a therapeutic area relevant to the pipeline is preferred.
• Experience with IND and NDA/BLA submissions is advantageous.
• Demonstrated passion, humility, and commitment to advancing research for patients with unmet medical needs.

Published Category: Medical Affairs