Associate Director, Clinical Trial Lead (all genders)

Merck; Eysins; Hybrid; CHF 120.000 - 180.000; Vollzeit

Zusammenfassung

Merck is seeking a seasoned Clinical Project Manager to lead Phase I–III studies and medical device investigations in a hybrid-sourcing or in-house model. You will steer large global project teams, shape clinical trial strategy, and ensure delivery within budget and timelines.

The role requires at least 8 years in clinical research with strong leadership, cross-functional collaboration, and deep knowledge of medical device regulations.

Qualifikationen

• Advanced degree in a relevant field; PM certification desirable.
• 8+ years in clinical research with 7+ years in trial management.
• Experience managing medical device clinical investigations.
• Expert experience across multiple therapeutic areas.
• Strong leadership and influencing abilities.

Aufgaben

• Manage Phase I-III studies and medical device trials in hybrid-sourcing or in-house model.
• Lead large global project teams in a matrix organization, directing stakeholders and creating a positive working climate.
• Develop the clinical trial strategy while ensuring successful execution, meeting timelines and budgets.
• Ensure study management activities comply with SOPs/WIs and local regulatory guidance (ICH-GCP, ISO 14155).
• Provide reports to senior management and mentor team members.

Kenntnisse

Leadership

Communication skills

Project management

Ausbildung

Advanced degree desirable

Jobbeschreibung

Work Your Magic with us!

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.

Your Role:

You will manage Phase I-III studies and medical device clinical investigations, including registrational studies, as well as projects with very high complexity, risk, impact and reach, in a hybrid-sourcing or in-house model. You will lead large-sized global project teams in a matrix organization, directing, influencing, and motivating stakeholders from closely related areas and beyond, and creating a positive working climate. You will develop the clinical trial strategy while being accountable for successful project execution and delivery of the clinical operational budget, timelines and quality standards agreed upon by Governance Committees. You will be a core member of the Clinical Operations Team and the leader of the Clinical Trial Team, aligning the trial team with organizational goals, the Clinical Operations Team and the Global Program Strategy Team.

You will 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 and mitigate risks. You will act as a mentor within the team and beyond, serving as a best-practice resource within your discipline or across technical functional teams or projects. You will ensure all study management activities are completed in accordance with SOPs/WIs and local regulatory guidance, including ICH-GCP and ISO 14155, as applicable, and including audit leadership and interview responses. You will contribute to non-study-related initiatives in addition to study assignments and provide reports to senior management, including updates and timelines, independently. You will demonstrate a high level of creativity and innovation to support projects from a strategic perspective, able to predict outcomes and drive toward goal achievement.

Who You Are

• Advanced degree desirable (MPH, MS, MA, MBA, PharmD); PM certification desirable.
• At least 8 years in clinical research in a CRO or Pharmaceutical/Biotechnology Industry environment with at least 7 years of in-depth knowledge and experience in clinical trial management including managerial responsibility.
• Proven experience in managing medical device clinical investigations
• Expert experience in multiple therapeutic areas.
• Strong professional experience in relevant disciplines and substantial project management experience, with strong market and competitor knowledge

• Expert experience in all aspects of clinical study planning and startup (including budget and resource planning), and in executing the complete range of clinical study activities from start up through final study report.
• Sound knowledge of applicable medical device regulations, standards and guidance, including ISO 14155, ICH-GCP and relevant regulatory requirements.
• Strong leadership competencies and influencing skills.
• Effective oral and written communication skills.
• Proven ability to foster partnerships across projects and multidisciplinary teams.

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!