Clinical Program Development Jobs in Malden, MA (NOW HIRING)

Job Summary:

The Senior Medical Director, Clinical Development is a senior physician-scientist who provides strategic medical leadership for one or more clinical programs within the organization's Inflammation & Immunology pipeline. Building on deep therapeutic area expertise and a proven track record in clinical trial execution, this role bridges hands-on clinical program leadership with broader cross-functional and organizational accountability. The Senior Medical Director serves as the primary physician lead for assigned assets, owning the clinical strategy and development plan across multiple phases, while also playing an increasingly prominent role in shaping departmental capabilities, mentoring junior physicians, and contributing to portfolio-level decision-making. This role requires the ability to work with independence and authority in a fast-paced, growth-stage biopharmaceutical environment.

Work Arrangement & Location: 

Hybrid - This position follows a hybrid work schedule, requiring a minimum of two (2) days on-site per week - currently designated as Tuesday and Wednesday. Additional on-site days may be required based on business needs, team priorities, or leadership direction.

Essential Duties and Responsibilities:

• Serve as the physician medical lead for assigned clinical development programs - owning the clinical development strategy, integrated development plan, and medical decision-making for pipeline assets across Phase I through Phase III development, with increasing accountability for program-level outcomes and portfolio contributions.
• Lead the design, authorship, and review of clinical trial protocols, investigator brochures, informed consent documents, and clinical sections of regulatory submissions (IND, NDA/BLA, global filings) - ensuring scientific rigor, patient safety, and regulatory compliance across all deliverables.
• Provide comprehensive medical oversight of ongoing clinical trials - including safety monitoring, medical monitoring, SAE assessment, protocol deviation review, and benefit-risk evaluation - in close partnership with Clinical Operations, Pharmacovigilance, and Biostatistics.
• Lead and actively represent the organization in regulatory agency interactions - including FDA and EMA meetings, briefing document development, and responses to health authority questions - serving as a primary medical spokesperson for assigned programs and contributing to regulatory strategy.
• Support pharmacovigilance activities during trial conduct - Drive cross-functional clinical program teams as the senior medical lead - providing strategic scientific direction to Clinical Operations, Regulatory Affairs, Translational Medicine, Biostatistics, and Medical Affairs - and ensure integrated, high-quality program execution with clear accountability and pace.
• Build and maintain relationships with key opinion leaders (KOLs), principal investigators, and academic medical centers to strengthen the organization's clinical network, gather external scientific insights, and support the medical positioning of pipeline assets.
• Perform other duties and responsibilities as assigned

Qualifications:

• Education: Advanced clinical degree (MD or DO) required. Board certification or clinical training in rheumatology, nephrology, immunology, or a related specialty strongly preferred. Additional advanced degree (PhD, MPH, or MBA) is a plus.
• Minimum of 10 years of combined clinical and pharmaceutical/biotech industry experience, with a minimum of 5 years in a clinical development role with increasing levels of responsibility preferred
• Deep scientific expertise in autoimmune disease - rheumatology preferred.
• Demonstrated experience as a physician lead on Phase I-III clinical programs, including hands-on protocol development, medical monitoring, and regulatory submission experience
• Deep clinical and scientific expertise in immunology and inflammation- including command of disease mechanisms, clinical trial landscapes, standard of care evolution, regulatory developments, and emerging therapeutic approaches
• Proven ability to identify, characterize, and mitigate clinical, operational, and regulatory risks across multi-site, multinational clinical programs
• Demonstrated ability to serve as the senior medical authority on cross-functional program teams - setting scientific direction, resolving complex medical questions, and building alignment across diverse functional stakeholders
• Strong track record of leading clinical programs through critical milestones - including first-in-human studies, proof-of-concept readouts, pivotal trial initiation, and regulatory submissions - with a bias for rigor, speed, and quality
• Effective at delivering data-driven recommendations to senior leadership, adapting communication to drive informed decision-making at the organizational and portfolio level
• Collaborative and influential leader who builds trust and credibility with clinical investigators, KOLs, and regulatory agencies - leveraging scientific expertise and interpersonal effectiveness to advance the organization's programs and reputation
• Exceptional scientific and medical communication skills - able to present complex clinical data, safety findings, and development strategies clearly and compellingly to diverse audiences including regulators, investigators, executives, and patient communities
• Skilled in authoring and reviewing high-quality clinical documents including protocols, investigator brochures, clinical study reports, regulatory briefing documents, and scientific manuscripts