The Director of Therapeutic Expertise for the center for rare diseases applies expert knowledge of therapeutic area, scientific discipline, and/or disease indications to support new business development, engage with clients, support project teams, and manage clinical projects. Additionally, the Director of TE advises on protocol development, patient recruitment, investigator selection, study feasibility, site identification, study design, endpoint assessment, and operationalizing clinical protocols. The CS also liaises with both external client and internal project teams to provide clinical, scientific, and therapeutic expertise in support of meeting clinical enrollment and timeline objectives.
- Responsibilities: Provides input to multidisciplinary project teams on site selection and patient enrollment estimates for proposed and awarded clinical projects. Serves as a point of escalation for study teams experiencing issues with site identification, enrollment, retention and site training.
- Provides training for clinical study team members. Contributes to the development of content and delivery of presentations for investigator meetings as needed.
- Identifies business opportunities for the company by researching pharmaceutical and biotechnology company pipelines; advises functional leaders and business development teams for consideration and action.
- Assists business development team members in closing prospective opportunities by participating in bid defenses and other client meetings. Participates in client meetings to address study issues and establish therapeutic expertise.
- Assists proposals team with responses to requests for information (RFIs) and requests for proposal (RFPs); advises on feasibility of prospective studies.
- Develops and maintains long-term professional relationships with relevant personnel in targeted client accounts and Key Opinion Leaders (KOLs) through effective networking.
- Keeps current on developments in area of expertise. Regularly reviews published literature. Identifies, attends and/or participates in conferences pertaining to area of expertise.
Additionally, the Director of TE may:
- Recommend changes to department processes and procedures to improve quality and efficiency.
- Guide internal project teams and clients on clinical development strategies.
- Leverage our broad data sources and interprets medical informatics analyses to inform clinical study planning.
- Qualifications: Bachelor's degree or international equivalent in a scientific, health or related field of study, required
- MS, PhD, PharmD, MD or international equivalent in a scientific, health or related field of study, preferred
- 5 + years of relevant experience in pharmaceutical development/clinical research, including experience with clinical study design, required
- Experience in rare disease research, strongly preferred
- Experience as Clinical Trial Manager, Study Manager, Clinical Research Coordinator, or Clinical Research Associate, strongly preferred
- Experience with protocol development, study feasibility and design, investigator and site selection, patient recruitment, and/or endpoint assessment, strongly preferred
- Experience with medical writing and presentations, strongly preferred
- Project management/leadership experience, strongly preferred
- Ability to travel domestically and/or internationally up to 25% of the time, required.
LOCATION: This is a home-based position. Consideration will be given to candidates across the US and Canada, but East coast locations are preferred.PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.