Conjugate Group | Director Clinical Operations | waltham, ma

6 days ago

waltham, United States Conjugate Group Full time

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.

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