Full-Time Director, Clinical Development Scientist

• Providing clinical leadership and strategic medical input for all clinical deliverables.
• Leading development of clinical sections of trial and program level regulatory documents.
• Driving execution of the program and/or clinical trial in partnership.
• Supporting the Clinical Development program lead by providing medical input.
• Literature review, KOL interactions, attending scientific meetings.
• Leading the protocol development for the new selected indication/s.
• Supporting and leading interactions with external and internal partners and decision boards.
• Medical monitoring of the assigned clinical trial/s, data and safety review.
• Working closely with the internal and external stakeholders as well as the clinical sites, and investigators to help ensure timely recruitment.

• MD, PhD, or PharmD required
• Experience in clinical development is required.
• Experience in rare diseases, neurology is highly preferred.
• Proven ability to work with cross functional teams, study vendors and clinical trial sites.
• Strong business communication skills, written and verbal.
• Knowledge – thorough understanding of GCP/regulatory requirements.
• Proactiveness – the ability to identify challenges and risks.
• Motivation – highly motivated and self-starter.
• Collaboration – to coordinate activities of internal cross-functional study team.
• Open-mindedness – listen to ideas from others and seek guidance when applicable.

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