Associate Director, Clinical Trial Lead

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

9d•Onsite

About The Position

As a core member of the Clinical Operations Team and leader of the Clinical Trial Team, aligns clinical trial team with organizational goals, Clinical Operations Team, and/or Global Program Strategy Team. Leads 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. Acts as a senior advisor and mentor within the team and beyond and serves as best practice resource within own discipline or as technical functional teams or projectsManage multiple studies, projects, and work streams with high complexity, risk, impact and reach, typically Phase III and registrational/sourcing models. Demonstrates skills in successfully leading large-sized global project teams in a matrix organization and directs, influences and motivates stakeholders from closely related areas and beyond, creating a positive working climate. Filters, prioritizes, analyzes and validates 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. Exhibits Subject Matter Expert level understanding of multiple functions and functional processes. Familiar with and considers overall company strategy. 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. Demonstrates creativity and innovation to support projects from a strategic perspective, able to predict the result of action in advance 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

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)
Requires substantial to extensive professional experience in relevant disciplines and substantial project management experience. Required and 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)

Responsibilities

Aligns clinical trial team with organizational goals, Clinical Operations Team, and/or Global Program Strategy Team
Leads 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
Acts as a senior advisor and mentor within the team and beyond and serves as best practice resource within own discipline or as technical functional teams or projectsManage multiple studies, projects, and work streams with high complexity, risk, impact and reach, typically Phase III and registrational/sourcing models
Demonstrates skills in successfully leading large-sized global project teams in a matrix organization and directs, influences and motivates stakeholders from closely related areas and beyond, creating a positive working climate
Filters, prioritizes, analyzes and validates 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
Exhibits Subject Matter Expert level understanding of multiple functions and functional processes
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
Demonstrates creativity and innovation to support projects from a strategic perspective, able to predict the result of action in advance and achieve goals