Associate Director, Clinical Trial Lead

EMD Serono, Inc.; Billerica (MA); On-site; USD 122,000 - 203,000; Full time

Benefits offered by this job

Health insurance

PTO (paid time off)

Retirement contributions

Other perquisites

Job summary

EMD Serono, Inc. in Billerica, MA is seeking a seasoned Clinical Trial Manager to oversee multiple Phase III studies in a global matrix organization. You will lead cross-functional teams to ensure delivery of trial milestones, budgets, and quality standards.

The role requires 8+ years in clinical research, strong leadership, and experience in startup through final study report. onsite work with travel less than 10% and a competitive salary with comprehensive benefits are offered.

Qualifications

• Bachelor's degree with 8+ 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.

Responsibilities

• Manage multiple studies, projects, and work streams with high complexity, risk, impact and reach, typically Phase III and registrational/sourcing models.
• Lead development of clinical trial strategy while accountable for trial execution, budgets, timelines and quality.
• Align clinical trial team with organizational goals and governance structures.
• Filter and prioritize complex information from diverse sources to mitigate risks.
• Provide reports to senior management with updates and timelines.

Skills

Clinical trial management

Leadership

Project management

Education

Bachelor's degree in clinical research

Job description

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.

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.
• Growing expertise in drug development, including some knowledge of interfaces and interdependencies of clinical development with other nonclinical & pharmaceutical development, regulatory, commercial/marketing)

Location

Billerica MA, Onsite

Travel

<10%; International and Domestic

Pay range for this position: $122,200 - $202,900. The offer range represents the anticipated low and high end of the base pay compensation for this position. 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 offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites.

What we offer

We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!