Director – Clinical Development, Medical Monitoring

This is a fully remote position, open to applicants in California.

📋 Description

• Act as the Medical Monitor for designated clinical trials, performing continuous assessments of emerging medical and safety data while collaborating closely with external CRO partners.

• Actively participate in the planning, execution, and assessment of ongoing clinical trials.

• Assist or oversee the preparation of materials for trial-related clinical committees, such as Data Monitoring Committees and Adjudication Committees.

• Aid in the strategic planning, authorship, and thorough review of documents submitted to regulatory authorities and ethics committees/IRBs, including protocols, CSRs, Investigator’s Brochures, DSURs, clinical briefing documents, and BLA/MAA submission components.

• Contribute to the strategic planning, authorship, and critical evaluation of scientific data disclosures, including slide presentations, posters, and publications.

• Foster professional relationships with external clinical opinion leaders, investigators, and consultants.

• Keep up-to-date with competitive intelligence and activities within the market/industry.

• Engage with external stakeholders, such as vendor thought leaders, and act as the primary liaison with assigned individuals or groups.

• Represent clinical development at both internal cross-functional and external meetings.

• Carry out additional responsibilities related to the clinical development of EFX as assigned.

⛳️ Requirements

• Board Certified MD or MD/PhD or equivalent qualification with pertinent medical experience.

• At least 3 years of relevant experience in clinical development within the biotech and/or pharmaceutical industry.

• Direct experience in executing and medically monitoring clinical trials.

• Strong understanding of GCP, ICH guidelines, and FDA/EMA/CHMP regulations.

• Excellent interpersonal and communication skills, with a proactive and collaborative approach.

• Proficient in searching, critically evaluating, interpreting, and synthesizing scientific literature and clinical trial data.

• Proven problem-solving capabilities and accountability for issues to facilitate timely resolutions.

• Adaptable with a keen attention to detail and effective under time and resource constraints.

• Comfortable working autonomously and within cross-functional teams, including collaboration with external vendors.

• Highly organized with strong prioritization and time-management abilities; capable of managing multiple projects simultaneously.

• Advanced proficiency in Microsoft Office (Word, Excel, PowerPoint).

• Experience in hepatology, MASH, or internal medicine is preferred.

• Experience with Phase 3 clinical trials is highly desirable.

• Familiarity with the preparation of documentation for BLA/NDA/MAA submissions is desirable.

• Understanding of the regulatory pathways across various health authorities is desirable.

🏝️ Benefits

• Company bonus based on individual and company performance.

• Long-term incentive compensation.

• Medical coverage.

• Dental coverage.

• Vision coverage.

• Life insurance.

• Disability insurance.

• 401(k) savings plan.

• Flexible spending accounts.

• Employee assistance program.

• Tuition reimbursement program.

• Group legal benefit.

• Critical illness benefit.

• Identity theft protection.

• Pet insurance.

• Auto/home insurance.

• Sick time.

• Flexible vacation policy.

• Parental leave policy.