Associate Medical Director/Medical Director, Endocrinology/Metabolism

Role Summary

The Associate Medical Director/Medical Director will be a key scientific leader for the clinical development of relacorilant, a cortisol modulator, for the treatment of endogenous hypercortisolism, and/or miricorilant, a liver-targeted cortisol modulator, for the treatment of MASH (metabolic associated steatohepatitis). This role involves providing medical oversight of ongoing and planned clinical trials, designing and implementing studies from Phase 1 through Phase 4, and contributing to regulatory submissions and scientific publications. The position requires strong clinical and scientific expertise, excellent cross-functional collaboration, and the ability to advance a fast-paced, small-company program.

Responsibilities

• Act as a clinical scientist and clinical subject matter expert for both Company team members and for external contacts related to the assigned therapeutic programs
• Provide medical oversight and safety monitoring for ongoing clinical trials including participation in SAE reporting and serving on the safety committee
• Design, develop and implement clinical studies for the applicable drug candidate, from Phase 1 through Phase 4
• Develop and give internal and external presentations as a subject matter expert for the therapeutic area
• Develop and participate in the writing and review of protocols, investigator brochures, study reports and other clinical and regulatory documents
• Establish and approve scientific methods for design and implementation of applicable clinical protocols, data collection systems and final reports
• Interact with principal investigators and opinion leaders to facilitate clinical trials research
• Participate in appropriate regulatory discussion and activities, including the filing of INDs, CTXs and NDA/MAAs, throughout the development cycle
• Participate in clinical study report conceptualization, development and writing for global regulatory submissions
• Participate in the development and review of publications
• Participate in the management of human resources in a matrixed environment – recruitment, performance management, succession planning, talent management, etc.
• Play a key role in the analysis, interpretation and delivery of high quality clinical data
• Prepare and monitor budgets in collaboration with clinical operations and R&D finance
• Provide scientific oversight for Company operational staff, CROs, and clinical trial sites in all areas related to the therapeutic programs
• Provide training and ongoing input to all members of the clinical team on medical and scientific issues related to the therapeutic field in question
• Serve as a liaison to the commercial team on medical issues
• Work closely and collaboratively with other functions, e.g. clinical operations, safety, biometrics, regulatory, medical writing, medical affairs and commercial

Skills

• Demonstrate strong clinical and scientific knowledge
• Are an excellent communicator with proven leadership skills and the ability to interact in a cross functional environment
• Feel comfortable in a fast-paced and nimble small company environment and able to adjust workload based upon changing priorities

Education

• MD, PharmD, or PhD with experience in Internal Medicine, Metabolic disease (e.g. MASH, Type 2 diabetes) or Endocrinology preferable
• 0-3 years of relevant clinical development experience
• Industry experience and experience medical monitoring is preferable