Director, Clinical Scientist

· MD, PharmD, or PhD within a clinical and/or scientific profession (or an equivalent level of professional, clinical and/or scientific education, training and experience) required.

· Facilitate and execute the generation, author, update, and/or review of key clinical and regulatory documents, including, but not limited to:

o Protocol concepts, synopses, protocols, and amendments o Informed consent documents o Investigator Brochures o Clinical study reports o Abstracts, posters and manuscripts o Clinical sections of INDs (and equivalent applications), NDAs (and equivalent applications), Annual Reports, and Developmental Safety Update Reports o Clinical sections of Health Authority Briefing Documents, Orphan Drug applications, and annual reports o Risks / benefits analysis for applicable documents o Clinical study supporting documentations and processes, e.g. charters for (independent) safety data monitoring or steering committee, study specific management plans and manuals, SOPs, etc.

· Instrumental to the Clinical Development Plan Generation and Program Strategy

· Primary contact and lead for all clinical and scientific aspects of the design, implementation, conduct, analysis, interpretation and documentation of clinical studies. Partner with relevant functional areas for the successful implementation and execution of clinical studies. Specific tasks will include but are not limited to the following:

o Provide clinical and scientific expertise for selection of investigator and vendors o Train internal colleagues, CRO staff, and study site staff on the therapeutic area, molecule, and/or clinical protocol o Provide scientific and medical support throughout conduct of a clinical trial; respond to clinical questions from sites, IRBs/IECs, Health Authorities, and CROs o Review, query, and analyze clinical trial data o Serve as medical monitor or partner with (senior) medical director on medical monitoring, patient eligibility and study treatment related questions, in cooperation with the CRO or directly with study investigator

· Interpret, and present clinical trial data, both internally and externally

· Create clinical study or program-related slide decks for internal and external use

· Represent a clinical study or development program on one or more teams or sub teams

· Build and maintain opinion leader/investigator networks; organize and present at key opinion leader advisory boards and investigator meetings, engage advocacy groups

· Contribute to or perform therapeutic area/indication research and competitor analysis

· Build strong relationships with internal experts.

· Identify continuous process improvement opportunities and help define/optimize standards and processes.

· Identify incremental organizational resource needs – staff, budget, and systems.

· Develop, track, execute and report on goals and objectives.

· Support budget planning and management.

· Be accountable for compliant business practices.