Assoc. Director, Clinical Trial Lead

About the Role

Manage multiple studies, projects, and work streams with high complexity, risk, impact, and reach, typically Phase III and registrational/sourcing models. Lead large-sized global project teams in a matrix organization, influencing and motivating stakeholders to create a positive working climate. Develop clinical trial strategy and ensure successful project execution, adhering to clinical operational budgets, timelines, and quality standards. Act as a core member of the Clinical Operations Team and align clinical trial teams with organizational goals.

Responsibilities

• Filter, prioritize, analyze, and validate complex information from diverse sources to mitigate risks and address operational challenges.
• Serve as a senior advisor and mentor within the team and beyond, acting as a best practice resource.
• Ensure all study management activities comply with SOPs, local regulatory guidance, and ICH-GCP.
• Contribute to non-study-related initiatives and provide independent reports to senior management.
• Demonstrate creativity and innovation to support projects strategically and predict outcomes.

Qualifications

• Bachelor's degree with a minimum of 8 years in clinical research in a CRO or Pharmaceutical/Biotechnology Industry environment.
• Minimum 7 years of in-depth experience in clinical trial management.
• Proven experience in clinical study planning, startup, and execution, including budget and resource planning.
• Experience in multiple Therapeutic Areas (oncology and immunology preferred).
• Strong leadership and influencing skills, with the ability to foster partnerships across multidisciplinary teams.

Preferred Qualifications

• Advanced degree (MPH, MS, MA, MBA, PharmD) or PM cPMP certification.
• Substantial professional experience in relevant disciplines and project management.
• Knowledge of drug development interfaces and interdependencies with nonclinical, regulatory, and commercial functions.

Location

Billerica, MA (Onsite)

Travel

Less than 10%; International and Domestic

Pay

$118,700 - $201,600. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses.

Benefits

Health insurance, paid time off (PTO), retirement contributions, and other perquisites.