Director of Clinical Operations (Waltham, MA)

The Director of Clinical Operations will leverage a strong scientific background and leadership expertise to advance programs from first-in-human studies to later-stage development. This individual will integrate scientific, clinical, and business considerations into cohesive study and program strategies. With exceptional cross-functional collaboration skills, the Director will achieve program goals while maintaining a comprehensive understanding of clinical indications, patient needs, development plans, regulatory guidelines, and the competitive landscape. This role is ideal for a professional who thrives in a fast-paced, patient-focused environment, demonstrating adaptability and innovative problem-solving.
 

• Plan, drive, and oversee all aspects of large, multi-center global clinical trials in compliance with GCPs, SOPs, and program budgets and timelines.

• Develop and execute clinical operational strategies for the successful delivery of assigned clinical studies.

• Lead Study Management Teams to develop and implement clinical protocols and associated plans.

• Collaborate with CRO Study Management Team leads to identify risks, implement mitigation strategies, and resolve issues proactively.

• Oversee high-quality execution and delivery of clinical trials within timelines and budgets by managing CROs.

• Foster a transparent, goal-oriented team culture with risk-based oversight.

• Manage CROs and vendors, including contracting, budget oversight, and contingency planning for clinical trials.

• Ensure compliance with internal policies, GCPs, and applicable regulations, maintaining inspection readiness.

• Contribute to the selection, qualification, and oversight of CROs and vendors.

• Support clinical development planning, including scenario planning, resource estimation, and operational strategy development.

• Bachelor’s Degree (Life Sciences preferred); advanced degree highly desirable.

• 10+ years of clinical development and operations experience, including leadership roles in global clinical studies and programs.

• Proven track record in initiating and delivering large Phase 2 and/or Phase 3 trials.

• Experience with respiratory clinical trials preferred.

• Strong leadership skills to manage large cross-functional teams effectively.

• In-depth knowledge of global regulatory and compliance requirements, including ICH GCP and local country regulations.

• Strategic thinker with the ability to balance high-level objectives with critical details.

• Global clinical operations experience across therapeutic areas, with a capacity for rapidly learning new indications.

• Exceptional written and oral communication skills for effectively conveying ideas and data to diverse stakeholders.

Department: Direct Clients
This is a full time position