Senior Director of Clinical Development

About the Role:

The Senior Director of Clinical Development will be instrumental in advancing clinical research strategies for obesity and liver disease candidates. This individual will ensure all programs meet stringent safety and quality standards required by the medical community and regulatory authorities. Working within a cross-functional team, the candidate will manage high-priority programs, contribute to strategic business development initiatives, and foster a collaborative environment of clinical research excellence. Reporting directly to the Vice President of Clinical Development, the candidate will demonstrate the ability to navigate both strategic and tactical dimensions of clinical program execution.

Responsibilities:

• Develop and implement clinical and regulatory strategies for assigned product candidates, including obesity and liver disease therapies.
• Collaborate with cross-functional teams to design and execute clinical development plans, ensuring alignment with company objectives.
• Draft and oversee critical trial documentation, including protocols, investigator brochures, and regulatory filings.
• Manage the execution of clinical trials, including investigator selection, recruitment strategies, data collection, and patient safety oversight.
• Identify and establish relationships with clinical trial sites, investigators, and thought leaders in the field.
• Align with the Pharmacovigilance team to manage and communicate safety data across protocols and external stakeholders.
• Author and support regulatory submissions, such as INDs, NDAs, BLAs, and amendments, ensuring compliance with applicable guidelines.
• Maintain and enhance clinical SOPs to uphold Good Clinical Practice (GCP) standards.
• Provide expertise and due diligence support for business development initiatives.
• Support data analysis, contribute to publications, and represent the company at conferences through presentations, abstracts, and posters.

Qualifications:

• Medical Degree (MD), preferably with a specialization in hepatology or metabolic diseases (e.g., diabetes, obesity).
• A minimum of 5 years of clinical development experience within the biopharmaceutical industry.
• Proficiency in developing clinical trial protocols and regulatory briefing documents.
• Demonstrated experience in presenting to executive leadership and managing large-scale budgets.
• Comprehensive knowledge of GCP, ICH guidelines, and regulatory compliance requirements.

Preferred Qualifications:

• Strong leadership skills with the ability to work in a dynamic, fast-paced environment.
• Experience engaging with regulatory authorities and external clinical stakeholders.
• A track record of managing cross-functional teams and external partners to deliver on program objectives.
• Expertise in designing and executing trials for obesity or liver disease therapeutic areas.
• Proven ability to manage complex projects, including budgets and timelines, efficiently and effectively.