Associate Director, Clinical Trial Lead

The businesses of Merck KGaA, Darmstadt, Germany•Billerica, MA

10d•$122,200 - $202,900•Onsite

About The Position

This role involves managing multiple complex clinical studies, typically Phase III and registrational/sourcing models. The Associate Director will lead the development of clinical trial strategy, ensuring successful project execution, and delivery within budget, timelines, and quality standards. They will act as a core member of the Clinical Operations Team and leader of the Clinical Trial Team, aligning trial teams with organizational goals. The position requires filtering and analyzing complex information to mitigate risks, demonstrating subject matter expert understanding of multiple functions, and serving as a senior advisor and mentor. Ensuring compliance with SOPs/WI and ICH-GCP, leading audits, and contributing to non-study related initiatives are also key aspects. The role demands creativity and innovation to support projects strategically, with the ability to predict outcomes and achieve goals.

Requirements

Bachelors degree with minimum 8 or more years in clinical research in a CRO or Pharmaceutical/Biotechnology Industry environment
Minimum 7 years of in-depth experience in clinical trial management
Demonstrated experience in managerial responsibility
Substantial to extensive professional experience in relevant disciplines and substantial project management experience.
Experience in own discipline and beyond which may also require good market and competitor knowledge.
Strong leadership competencies and influencing skills.
Proven team dynamic knowledge and skills and ability to foster partnerships across projects and multidisciplinary teams.
Growing expertise in drug development, including some knowledge of interfaces and interdependencies of clinical development with other nonclinical & pharmaceutical development, regulatory, commercial/marketing)

Nice To Haves

Advanced degree desirable (MPH, MS, MA, MBA, PharmD); PM cPMP) desirable.
Proven experience in all aspects of clinical study planning and startup (including budget and resource planning) and in executing study activities, from startup through final study report.
Experience in multiple Therapeutic Areas (oncology and immunology preferred)

Responsibilities

Manage multiple studies, projects, and work streams with high complexity, risk, impact and reach, typically Phase III and registrational/sourcing models.
Lead the development of the clinical trial strategy while accountable for successful project execution and delivery of clinical operational budget, timelines and quality standards agreed upon by Governance Committees.
Align clinical trial team with organizational goals, Clinical Operations Team, and/or Global Program Strategy Team.
Filter, prioritize, analyze and validate complex and dynamic information from a diverse range of external and internal sources to respond to operational and organizational challenges in a holistic manner to mitigate risks.
Ensure all study management activities will be completed in accordance with SOPs/WI, local regulatory guidance including ICH-GCP; audit leadership- interviewee & responses.
Contribute to non-study -related initiatives in addition to study assignments.
Provide reports to senior management, including updates and timelines independently.
Demonstrate creativity and innovation to support projects from a strategic perspective, able to predict the result of action in advance and achieve goals.