Associate Director, Clinical Trial Lead

Work Your Magic with us! Start your next chapter and join EMD Serono.
Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.
This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.
Your Role:
Manage 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.
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.
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.
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.
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 projects.
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.
Who You Are
Minimum Qualifications:
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
Preferred Qualifications:
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.