Lead Clinical Trials Strategist
The role of the Lead Clinical Trials Strategist is to oversee the development and execution of clinical trials within a molecule level book of work. This includes planning, budgeting, and overseeing key trial deliverables with Third Party Organizations (TPOs). The ideal candidate will have expertise in clinical project management, vendor management, and strategic planning.
Clinical Trial Leadership
This position involves leading global clinical teams to resolve implementation issues, manage risk assessments, and implement safety management processes. The successful candidate will be able to influence and communicate effectively at all levels across the organization, including leadership and governance forums.
Responsibilities
- Develop and lead clinical asset strategies for exploratory and biopharmaceutics clinical development studies.
- Provide consultation on clinical and regulatory documents, such as study protocols, Investigator Brochures (IBs), and New Drug Applications (NDAs).
- Stay informed about current body of knowledge in relevant disease states, competitors, and industry trends.
- Maintain up-to-date knowledge of operational requirements to plan detailed exploratory and biopharmaceutics clinical development studies and submissions.
Clinical Project Management Skills
This role requires expertise in implementing and integrating clinical project management processes and tools. The successful candidate will be able to work with TPOs to execute defined clinical strategies and oversee key trial deliverables. They will also develop and maintain clinical plan timelines and process maps to ensure communication of progress to the broader molecule team.
Requirements
- Bachelor's degree in a science-related field from an accredited college or university.
- 3 years' experience in the pharmaceutical industry with direct experience of managing clinical studies, ideally in exploratory and biopharmaceutics clinical development (5+ years preferred).
- Strong knowledge of regulations and guidelines that apply to the conduct of clinical trials.
- Advanced scientific degree and strong leadership skills are desired.
Benefits
The successful candidate will receive a competitive salary and benefits package. Opportunities for career growth and professional development are available. The company is committed to diversity, equity, and inclusion and strives to create a workplace where everyone can thrive.