Clinical Trial Leader
- Antareslaan 41, 2132 JE Hoofddorp, Netherlands
For one of our external clients in Amsterdam we are looking for a Clinical Trial Leader. This pharmaceutical company create value through innovation with one clear goal: to improve the lives of patients. They develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company, they focus on long-term performance. Powered by 50.000 employees globally who nurture a diverse, collaborative and inclusive culture. Learning and development for all employees is key, because your growth is their growth.
Are you ready to join a truly global team? We are looking for a Clinical Trial Leader (CTL) to be part of the Global Clinical Operations team. As a CTL you will be accountable for the operational management (planning, set up, conduct and reporting) of international clinical trials around the world.
As Leader of the Trial Team, you will maintain oversight, ensure feasibility of trial plans and pro-actively assess and mitigate risks, supporting Project Teams to provide clinical operations guidance and to drive feasibility of clinical trial protocols.
The position is based in their regional diverse Amsterdam office and will require some international travelling (based on the clinical trials you are accountable for).
Duties & Responsibilities:
- Lead development of core trial documents (e.g. Clinical Trial Protocol, Integrated Quality Risk Management Plan, (IQRMP)), and Patient facing documents
- Define and drive trial timelines and milestones to ensure business deliverables
- Work with functional partners to ensure that all required trial processes are in place in a timely manner
- Ensure provision/provides appropriate trial-specific and medical training of the trial team and external partners
- Define the needs for External Service Providers (ESP), identify and select ESPs in collaboration with relevant internal stakeholders and overseeing the vendor services
- As a CTL you will be a member of the Medical sub-team: i) supports the design, preparation of clinical trials, including definition of trial milestones; ii) contributes operational, scientific and medical expertise; iii) provides advice on safety aspects and risk benefit assessments; and iv) consider regulatory implications
- Develop and maintain company relationships with external experts and investigational sites by coordinating and ensuring cross-functional collaboration amongst Clinical Operations and Medical Affairs on Global /Regional level
- Collaborate with other functions in the company to support Trial Management topics and support integration across Medicine
- University degree in life sciences or related field, higher degree/qualification preferred (e.g. MSc, PhD)
- Project management skills including oversight of teams to achieve planned timelines and milestones (4 to 6 years of leadership experience; leading projects)
- Experience in the Therapeutic Areas of dermatology, psychiatric disorders, paediatrics, lupus and metabolic disorders of liver/kidney is considered an asset
- Excellent command of the English language
- Understanding of major regulations (FDA, EMA and PMDA)
- Familiarity with guidelines and standard of care is desirable
- Strong and in-depth understanding of team work and high-performance teams
- Working in multi-cultural environment and in-depth understanding of corporate culture and cross-culture dynamics
- Problem solving and resolution through trend identification and appropriate implementation of mitigation plans
- Adapts communication style to audience to effectively influence stakeholders. Demonstrates active listening skills and cultural awareness
- Scientific and Operational Expertise: Demonstrates scientific knowledge and operational expertise across all aspects of clinical trial execution i.e. start-up, conduct and reporting. Dimensions of trial complexity include protocol phase and indication
- Leadership and Influence: Inspires team to achieve a common goal. Translate complex situations to actionable parts. Anticipate and resolve challenges through effective influencing of cross functional team members and management
- Strategic Mindset: Anticipates future trends and needs and translate them into strategies that fits the overall TA portfolio and the ambition and values of Boehringer Ingelheim. Contributes to cross functional initiatives within and beyond medicine
- Project Management: Plans, sets priorities, defines actions, makes effective use of resources, and proactively strives for clarity to accomplish the business deliverables