Associate Director, Clinical Development Medical Director (MD Required)

Role Summary

Associate Director, Clinical Development Medical Director (MD Required).

Responsibilities

• Is accountable for the medical and scientific integrity of the study and the wellbeing of patients enrolled in one or more clinical trials; applies technical and clinical/medical skills to ensure efficient and high-quality trial design using quantitative design principles and clinical best practices to deliver clinical and operational excellence.
• Responsible for effective execution of studies; collaborates with clinical/medical colleagues, clinical operations, and other functional lines; ensures timely delivery of quality protocols, clinical trial execution, and supports interpretation and communication of trial data.
• Maintains compliance with internal and external standards; proactively mitigates risk and manages emerging clinical/medical issues through timely data review; may perform medical monitoring of trials.
• Primary contact with external investigators and internal study team for questions relating to clinical/medical aspects of the protocol; partners with Global Development Lead regarding study and disease area strategy.

Qualifications

• Required: Primary medical degree (MD, DO, MBBS, MBChB) with clinical research experience; licensed to prescribe medicines independently for at least 2 years post intern years; maintenance of Medical License in good standing; clinical research experience in phase 3/pivotal space; demonstrated scientific writing skills (publications, posters, abstracts, or presentations).
• Preferred: Industry/CRO clinical research experience; cardiometabolic disease experience (cardiology, obesity, endocrinology, nephrology, etc.); extensive knowledge of clinical development, global/regional regulation, ICH/GCP, and adverse event management; strong English written and verbal communication; proven clinical/medical, administrative, and project management capabilities.

Skills

• Medical monitoring and interpretation of safety data; ability to respond to investigator questions and complex SAEs; ability to author and manage informed consent documents; data monitoring and safety review process knowledge; ability to contribute to regulatory submissions and trial documentation; strong collaboration and communication skills.

Education

• Medical degree required (MD, DO, MBBS, MBChB).

Additional Requirements

• Global travel may be required.
• Hybrid work arrangement: on-site ~2.5 days per week if within commuting distance.