Job Description

Our client is seeking an experienced Director, Clinical Development to join their team and embark on a unique journey of advancing their clinical development programs in rare cholestatic liver disease. In this position, you will be an integral part of the clinical development team, supporting the execution of late-stage clinical studies. The ideal candidate will have outstanding communication skills, attention to detail, and the ability to thrive independently in a highly innovative and fast-paced environment. Provide medical expertise and leadership in designing and implementing clinical development strategies aligned with company objectives.

Job Responsibilities

1. Clinical Trial Strategy and Design:
• Collaborate with cross-functional teams (including Clinical Operations, Biostatistics Regulatory Affairs, Patient Safety, and Pharmacology/Pharmacometrics) to design and implement clinical trials
• Ensure that clinical trial protocols align with scientific and regulatory requirements
• Oversee patient recruitment, data collection, and safety monitoring during trials
2. Medical Oversight:
• Provide medical expertise to study teams, investigators, and site staff
• Review and interpret clinical trial data, including safety and efficacy endpoints
• Make informed decisions based on medical insights to optimize trial outcomes
3. Regulatory Interactions:
• Engage with regulatory agencies (such as the FDA or EMA) during clinical development
• Prepare and submit clinical trial applications, investigator brochures, and other regulatory documents
• Address regulatory queries and ensure compliance with guidelines
4. Clinical Development Strategy:
• Contribute to the overall clinical development strategy for the company’s pipeline products
• Identify opportunities for expansion into new indications or patient populations
• Evaluate scientific literature and competitive landscape to inform strategic decisions
5. KOL Engagement and Scientific Communication:
• Build relationships with Key Opinion Leaders (KOLs) in relevant therapeutic areas
• Present clinical trial results at scientific conferences and meetings
• Collaborate with external experts to enhance product understanding
6. Team Leadership and Mentorship:
• Depending on the candidate's expertise level, the responsibilities may include leading a team of clinical professionals, including Clinical Scientists and Medical Monitors
• Effectively fosters productive and collegial working relationships with internal and external stakeholders in a cross-functional, matrix environment

Additional Info

• This is a hybrid/remote role for the candidate; however, if the candidate is local to the area, the candidate will be expected to come into the office occasionally
• Advanced scientific degree (MD or DO, PhD, PharmD)
• Must have experience leading all aspects of clinical trials
• Must have pharma clinical trial /R&D experience (3-5 years)
• Rare disease experience and or gastroenterology/hepatology experience in clinical development preferred
• Solution- and results-oriented, with a sense of urgency
• Must have experience and be willing to perform in-depth clinical data review