Associate Director, Start-up Lead, SiteID & Activation

EMD Serono, Inc.; Billerica (MA); On-site; USD 129,000 - 193,000; Full time

Benefits offered by this job

Health insurance

Paid time off

Retirement contributions

Perquisites

Job summary

EMD Serono, Inc. in the United States is seeking an experienced clinical research leader to serve as Associate Director, Start-up Lead, SiteID & Activation to drive start-up strategies across our global trial portfolio.

You will oversee country/site feasibility, regulatory submissions, and activations from protocol through implementation, collaborating with internal teams and external providers to accelerate timelines and ensure ICH-GCP compliance.

Qualifications

• Medical or Life Sciences degree or equivalent qualification.
• 10+ years in clinical research in a CRO or Pharmaceutical/Biotechnology industry.
• 5 years of project management and study start-up experience.
• Thorough knowledge of ICH-GCP and applicable laws and regulations for key countries.
• PM certification (CPM, PMP) preferred.

Responsibilities

• Oversee country and site feasibility assessments.
• Drive regulatory submissions and site activations from protocol through implementation.
• Collaborate with internal teams and external service providers to accelerate study timelines and optimize recruitment outcomes.
• Champion process improvements.
• Manage performance metrics.
• Drive operational excellence to bring medicines to patients faster.
• Ensure compliance with ICH-GCP standards and applicable regulations.

Skills

Project management

Clinical trial operations

Regulatory compliance

Data-driven decision making

Communication skills

Agile methodologies

Education

Medical or Life Sciences degree

PM certification (CPM, PMP)

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

We are seeking an experienced clinical research professional to serve as the Associate Director, Start-up Lead, SiteID & Activation to lead start-up and site activation strategies across our global clinical trial portfolio.

Key Responsibilities

• Oversee country and site feasibility assessments
• Drive regulatory submissions and site activations from protocol through implementation,
• Collaborate with internal teams and external service providers to accelerate study timelines and optimize recruitment outcomes
• Champion process improvements
• Manage performance metrics
• Drive operational excellence to bring medicines to patients faster
• Ensure compliance with ICH-GCP standards and applicable regulations

Who You Are

Minimum Qualifications:

• Medical or Life Sciences degree or equivalent qualification
• 10+ years in clinical research in a CRO or Pharmaceutical / Biotechnology Industry environment
• 5 years of project management and experience in study start-up activities
• Thorough knowledge of ICH-GCP and applicable laws and regulations for key countries

Preferred Qualifications:

• PM certification (CPM, PMP)
• Strong communication skills -verbal, written and listening
• Fail fast and data driven mentality as well as agile methodology
• Strong data insights and analytical skills to identify trends and drive quality / process improvements.
• Ability to balance competing priorities of various stakeholders and strive for achieving mutually beneficial and compliant solutions. Experience in multiple Therapeutic Areas, especially in oncology

Pay Range for this position: $128,700 - $193,000

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.

Direct link to benefits site if the hyperlink no longer works: https://careers.emdgroup.com/us/en/benefits].

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!