Associate Director, Clinical Trial Lead (all genders)
The businesses of Merck KGaA, Darmstadt, Germany · GB
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About the Role
Own the end-to-end clinical operational strategy and delivery of Phase I -IV studies, including registrational trials, within a hybrid-sourcing or in-house model. Lead large-sized global clinical trial teams in a matrix organization, directing, influencing, and motivating stakeholders across closely related and broader functional areas to create a high-performing, positive working climate. Develop and drive the clinical trial strategy while maintaining full accountability for successful project execution, including the delivery of clinical operational budgets, timelines, and quality standards as agreed upon by Governance Committees. Align trial activities with organizational goals, the Clinical Operations Team, and the Global Program Strategy Team. Filter, prioritize, analyze, and validate complex and dynamic information from a diverse range of internal and external sources to address operational and organizational challenges in a holistic manner, proactively mitigating risks. Serve as a mentor within and beyond the team, acting as a best-practice resource across your discipline and technical functional teams. Ensure all study management activities are completed in full compliance with SOPs, Working Instructions, and local regulatory guidance, including ICH-GCP, and will lead audit activities and provide interview responses as required. Contribute to non-study-related initiatives alongside study assignments, provide independent reports and updates to senior management, and demonstrate a high level of creativity and innovation to support projects from a strategic perspective, predicting outcomes and driving toward goal achievement.
Responsibilities
- Own the end-to-end clinical operational strategy and delivery of Phase I -IV studies
- Lead large-sized global clinical trial teams in a matrix organization
- Develop and drive the clinical trial strategy
- Maintain full accountability for successful project execution
- Align trial activities with organizational goals
- Filter, prioritize, analyze, and validate complex and dynamic information
- Serve as a mentor within and beyond the team
- Ensure all study management activities are completed in full compliance with SOPs, Working Instructions, and local regulatory guidance, including ICH-GCP
- Lead audit activities and provide interview responses as required
- Contribute to non-study-related initiatives
- Provide independent reports and updates to senior management
- Demonstrate a high level of creativity and innovation to support projects from a strategic perspective
Requirements
- At least 8 years in clinical research in a CRO or Pharmaceutical/Biotechnology Industry environment
- At least 7 years of in-depth knowledge and experience in clinical trial management including managerial responsibility
- Expert experience in multiple Therapeutic Areas
- Strong professional experience in relevant disciplines
- Substantial project management experience
- Strong market and competitor knowledge
- Expert experience in all aspects of clinical study planning and startup (including budget and resource planning)
- Expert experience in executing the complete range of clinical study activities from start up through final study report
- Strong leadership competencies and influencing skills
- Effective oral and written communication skills
- Proven ability to foster partnerships across projects and multidisciplinary teams
Skills
- Clinical trial management
- Leadership
- Influencing
- Communication (oral and written)
- Partnership building
- Project management
- Market and competitor knowledge
- Clinical study planning and startup
- Clinical study execution
- Mentoring
Location
- Feltham, UK
Work Type
- On-site (3 days per week)
- Hybrid
Experience Level
- 8+ years in clinical research
- 7+ years in clinical trial management
- Managerial responsibility
Education Level
- Advanced degree desirable (MPH, MS, MA, MBA, PharmD)
- PM certification desirable
About the Company
- Colleagues across the globe innovate with science and technology to enrich people’s lives with solutions in Healthcare, Life Science, and Electronics.
- The company dreams big and is passionate about caring for its rich mix of people, customers, patients, and planet.
- The company is always looking for curious minds that see themselves imagining the unimaginable.
- Purpose in Healthcare is to help create, improve and prolong lives.
- Develops medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility.
- Teams work together across 6 continents with passion and relentless curiosity to help patients at every stage of life.
- Offers a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.
- Believes that a variety of backgrounds, perspectives, and life experiences drives excellence and innovation, strengthening the ability to lead in science and technology.
- Committed to creating access and opportunities for all to develop and grow at their own pace.
- Building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress.
- Dedicated to Sparking Discovery and Elevating Humanity.