Sr. Medical Director

• Provide medical input into the design of clinical trials
• Serve as medical monitor for clinical studies (provide medical oversight of the study, answer questions about patient eligibility, review protocol deviations, review safety and adverse event information and any general medical-related study issues during the conduct of a trial)
• Work closely with cross functional study team, including external partners to ensure proper execution of ongoing clinical studies and initiation of new clinical trials to meet key milestones
• Work closely with pharmacovigilance and safety representatives providing medical input into safety reports and communicate with CRO/investigators regarding follow-up
• Assist in preparation/review of clinical protocols, informed consent, investigator brochure, DSUR, briefing books, clinical publications, IND and any other relevant clinical and regulatory document
• Play a medical leading role in NDA preparation including preparation/review of integrated summaries of safety and efficacy
• Provide clinical leadership in preparation for and interactions with Regulatory Authorities
• Cultivate and nurture collaborations with Investigators, academic partners, and KOL’s as applicable
• Present at investigator meetings, site visits, scientific/clinical meetings
• Play lead medical expert role in establishing additional and novel therapeutic indications for KorsuvaTM as applicable
• MD with a minimum of 5 years of pharmaceutical/biotech-industry experience in a medical monitoring/leading role (Phase I-III) ideally with experience pre- and post-approval
• Nephrology or dermatology experience a plus, although not required
• Experience providing input into key regulatory documentation a must along with experience interacting directly with regulatory agencies
• Relevant experience and understanding of strategic and operational aspects of clinical research and product development a must
• US and EU experience preferred
• Excellent clinical and scientific judgment, organizational skills and strong leadership ability in communication and networking
• Strategic thinking and ability to work with collaborators
• Ability to produce written scientific/medical communications with clarity, accuracy and rigor
• Demonstrates the ability to communicate effectively through formal presentation and through informal scientific/medical discussion with credibility, accuracy, and confidence with ability to relate to both internal and external stakeholders
• The position is based in Stamford, CT

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