The Senior Director, Global Feasibility and Patient Recruitment for Rare Diseases, will build an organization within Global Clinical Development Operations (GCDO) to support study feasibility and patient recruitment. This is a unique opportunity to build a function that is able to manage, support development, drive endorsement, develop processes and execute clinical recruitment initiatives. S/he will also build strong relationships with internal stakeholders from Clinical Development, Clinical Trial Teams, Patient Advocacy, Commercial Strategy, Regulatory Strategy, and Medical Affairs to ensure that all input is factored into defining patient recruitment strategies.
This position will report to the Vice President, Global Clinical Development Operations.
Primary responsibilities include:
- Building a function that will focus on developing recruitment and retention strategies (concepts and branding), plans, and materials as appropriate in collaboration with clinical trial teams, CROs and other internal stakeholders.
- Drive and partner withCROs on the preparation of recruitment packages for internal compliance and external review boards as needed.
- Provide leadership and expertise for study, country and site feasibility tasks, conducting historical study searches, benchmarking assumptions and accurate planning that are required for the delivery of clinical trials.
- Support the clinical trial teams to drive rapid, accurate and robust assessments of feasibility and recruitment planning.
- Collaborate with Clinical Outsourcing and Vendor Management in the evaluation, selection and management of vendors to ensure successful recruitment implementation and execution.
- Engage internal and external stakeholders to identify potential new investigators and maintain knowledge of current investigators in alignment with clinical development plans.
- Develop and maintain knowledge of external local clinical trial environment and assess developments for impact on study design and execution.
- Define SOP curriculum and ensures departmental adherence to all relevant SOPs and regulatory policies, this includes but not limited to an SOP for conducting study feasibility.
- Provide leadership and guidance on shared learnings with and across teams throughout planning and implementation, as well as ensure clinical operational and development deliverables and timelines are met across the development program(s).
Education and skills requirements:
- Bachelor’s Degree in life sciences with minimum of 15 years of equivalent pharmaceutical or biotechnology industry experience; rare disease experiencepreferred.
- At least 5 years in a similar role which includes country strategy, patient recruitment, branding studies and working with teams or vendors to develop patient recruitment
- Thorough knowledge and understanding of drug development and the clinical trial process.
- Expert knowledge of global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, local country requirements and ICH GCP.
- Ability to work effectively in a collaborative team environment where results are achieved through influence, cooperation, and the incorporation of multiple points of view.
- Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient.
- Independently motivated, detail oriented, and good problem solving ability.
- Excellent analytical and organizational skills, with an ability to embrace change and multi-task in an extremely fast-paced environment.
- Excellent communications skills and ability to influence across multiple functions.