Job title: Associate Medical Director
Reports to: Medical Director

Job purpose:

The incumbant will be instrumental in supporting Cara’s projects in the development of a first-in-class, novel compound (Difelikefalin – oral formulation) for the symptomatic treatment of patients with chronic pruritus. The incumbent will have hands-on responsibility for monitoring the clinical studies and providing medical guidance to the clinical team. This role will require deft execution in a rapid pace biotech environment.

Duties and responsibilities include but not limited to:

• 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, MedDRA/WHO drug coding 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, provide medical queries for SAEs and AEs and communicate with CRO/investigators regarding follow-up
• Assist in preparation/review of clinical protocols, CRF, medical monitoring and safety management plans, informed consent, IB, DSUR, TLFs, CSRs and any other relevant clinical documents
• Participate in preparation of clinical sections in support of IND, briefing book and NDA, as applicable
• Present at investigator meetings, site visits, scientific/clinical meetings, as applicable

Qualifications include but not limited to:

• Medical Degree; specialization in Dermatology, Neurology or Internal Medicine desirable.
• Experience in medical monitoring (Phase II – III) within the pharma/biotech or CRO industry is desirable.
• Excellent clinical and scientific judgment, organizational skills and strong leadership ability in communication and networking
• Ability to produce written scientific/medical communications with clarity, accuracy and scientific rigor
• Demonstrated ability to communicate effectively through formal presentation and through informal scientific/medical discussion with credibility, accuracy, and confidence
• Ability to contribute to a team environment with a high degree of professionalism and skill.
• Comfortable working with Senior Executive Team and other external audiences such KOLs and Regulatory Agencies
• Experience in communicating with the FDA and other global Health Authorities is desirable.
• Strategic thinking and ability to work with collaborators
• Able to work well in a fast-paced environment with demonstrated ability to simultaneously manage multiple competing tasks and demands.
• Ability to work independently, take initiative and complete tasks to deadlines.
• Excellent interpersonal, analytical, and organizational skills.

Travel: Less than 10%

Candidates must be a U.S. citizen or lawful permanent resident of U.S. or otherwise authorized to work in the U.S. without requiring sponsorship now or in the future.