Medical Director

Elixir Associates; United States; On-site; USD 180,000 - 240,000; Full time

Job summary

Elixir Associates seeks a Medical Director, Clinical Development for Gastroenterology assets to lead physician medical oversight for IBD programmes.

The role includes acting as Medical Monitor, shaping development strategy, contributing to INDs and regulatory interactions with FDA/EMA, vendor management, and mentoring clinical staff.

Qualifications

• MD required with medical accountability for eligibility decisions and safety.
• Industry clinical development experience in gastroenterology/IBD.
• Experience as Medical Monitor, preferably in Phase 2.
• Strong knowledge of ICH-GCP and FDA/EMA/global regulatory requirements.
• Excellent cross-functional and project leadership.

Responsibilities

• Lead the cross-functional study team and manage CROs and labs.
• Oversee development strategy, endpoints, and CSR collaboration.
• Interface with FDA/EMA on INDs and briefing documents.
• Mentor staff and build KOL networks.
• Ensure data quality and interpretability of Phase 2 results.

Skills

Medical Monitor

Cross-functional leadership

Regulatory strategy

Education

MD or MD-PhD

Job description

Medical Director, Clinical Development: Gastroenterology Assets

We are partnered with a well-funded clinical-stage biopharmaceutical company advancing a novel therapy for inflammatory bowel disease, engineered for targeted activity in the lower gastrointestinal tract to maximise local efficacy while limiting systemic exposure.

The role: Physician medical lead for programmes in IBD.

• Medical Monitor for the programme. Eligibility calls, deviations, AESIs and SAEs, dose modification decisions, and the blinded safety trends nobody else is watching. The medical judgement sits with you.
• The development strategy. Clinical development plans, protocols, investigator brochures and CSRs, working with Biostatistics on endpoint strategy and estimands for induction and maintenance designs with endoscopic and histologic endpoints.
• The FDA conversation. Medical input into INDs and briefing documents, and a seat at health authority interactions with FDA, EMA and global agencies.
• Execution, sponsor-side. Lead the cross-functional study team, select and manage CROs, central labs and imaging vendors, and hold the medical view on enrolment trends, central endoscopy and histology outputs, and the data quality issues that decide whether Phase 2 is interpretable.
• The external face. Build the KOL and investigator network, support publications and business development, and mentor the medical and scientific staff who come in behind you.

Requirements:

An MD is required. The postholder is a sponsor Medical Monitor, with medical accountability for eligibility decisions, adverse event causality and dose modification. Applications from non-physicians cannot be considered.

• MD or MD PhD
• Industry clinical development experience in gastroenterology /IBD.
• Demonstrated experience as Medical Monitor, ideally in Phase 2
• Strong working knowledge of ICH-GCP and FDA, EMA and global regulatory requirements
• Excellent cross-functional and project leadership