A clinical-stage biotechnology company based in Waltham, with a primary focus on severe respiratory disorders, is seeking a dynamic and strategic leader to oversee late stage clinical trial operations . The Clinical Operations Director will be instrumental in planning, managing, and ensuring the successful execution of clinical studies within an outsourced framework. This role demands a proactive approach to guiding clinical operations, ensuring that project milestones and timelines are achieved. The position reports directly to the Head of Clinical Operations.
Key Responsibilities:
Lead the comprehensive management of large-scale, multi-center global clinical trials, ensuring adherence to Good Clinical Practices (GCP), Standard Operating Procedures (SOPs), and alignment with budgetary and timeline constraints.
Develop and implement robust clinical operational strategies to facilitate the effective delivery of clinical studies, collaborating closely with Clinical Research Organizations (CROs) and internal stakeholders.
Identify potential risks and devise proactive mitigation strategies in partnership with CRO counterparts, ensuring seamless study progression.
Manage relationships with CROs and vendors, overseeing contract negotiations, budget management, and the development of contingency plans for clinical trials.
Ensure all clinical activities comply with internal policies, GCP standards, and relevant regulatory requirements, maintaining a state of inspection readiness.
Participate in the selection and qualification processes for CROs and vendors as needed.
Qualifications:
Bachelor's Degree in Life Sciences or a related field; an advanced degree is highly desirable.
A minimum of 8 years of experience in clinical development/operations, with a proven track record in leadership roles overseeing global clinical studies and programs
Experience in managing Ph2 or Ph3 clinical trials within the respiratory therapeutic area is preferred.
Skills and Abilities:
Demonstrated leadership capabilities in managing large, cross-functional teams.
In-depth understanding of global regulatory and compliance requirements for clinical research, including local regulations and ICH GCP guidelines, with experience in global regulatory inspections.
Strong strategic and analytical thinking skills, with the ability to integrate detailed scientific, clinical, and business information into cohesive operational strategies.
Proven experience in global clinical operations and development across various therapeutic areas, with the capacity to quickly adapt to new indications.