Director, Clinical Development

Job Summary

Reporting to the VP Clinical Development, the Director, Clinical Develoment will contribute to the execution of the Phase 3 clinical development programme for Efruxifermin (EFX). Key responsibilities include, but are not limited to clinical trial execution, medical monitoring, data analysis and reporting of results for regulatory submissions or scientific presentations and publications. The Director, Clinical Development will be responsible for clinical guidance within the organization and will serve as a medical expert both internally and externally.This position demands strong collaborative and communication skills, including the ability to engage with a diverse range of internal and external stakeholders.

Job Responsibilities

• Play an active role in planning, conduct and evaluation of ongoing clinical trials to ensure successful execution
• Serve as Medical Monitor for assigned clinical trials, conducting ongoing review of emerging medical/safety data and working closely with external CRO partners
• Support/manage preparation of materials for trial-related clinical committees such as Data Monitoring Committees, Adjucation Committees, etc.
• Contribute to planning, authoring, and critical review of documents submitted to regulatory authorities and ethics committee/IRBs as required (e.g., Protocols, CSRs, Investigator’s Brochure,  DSURs, clinical briefing documents, components of BLA/MAA submissions)
• Contribute to the strategic planning, authoring, and critical review of scientific data disclosures (e.g., slide presentations, posters and publications)
• Develop professional relationships with external clinical opinion leaders, investigators, and consultants and stay abreast of competitive intelligence and other market/industry activities
• Contribute to engagement with external stakeholders such as vendor thought leaders or other groups as needed including being the primary liaison with assigned individuals or groups.
• Function as an independent member of the team and represent clinical development at internal cross-functional or external meetings
• Other duties related to clinical development of EFX as assigned

Qualifications

• Board Certified MD or MD/PhD or equivalent qualification with relevant medical experience
• Experience in hepatology, MASH or internal medicine preferred
• At least 3+ years of relevant experience in clinical development in the biopharmaceutical industry
• Direct experience of Phase 3 clinical trial execution and medical monitoring
• Experience with preparation of documentation for BLA/NDA/MAA submissions desirable
• Knowledge of the regulatory path across the various health authorities (FDA, EMA etc) desirable
• Experience in multiple therapeutic areas, with prior experience in Hepatology, Gastrointestinal, Endocrinology or related field, preferred.

Technical Requirements and Skills

• Familiarity with GCPs, ICH guidelines and FDA/ EMA/CHMP regulations and ability to apply relevant principles, practices and standard to conduct GCP-compliant trials
• Demonstrated ability to author or oversee regulatory documents (e.g protocols, CSRs, briefing packages)
• Strong interpersonal and communication skills; proactive approach.
• Expertise in navigating scientific literature and ability to critically evaluate, interpret and synthesise scientific and clinical trial data
• Demonstrated problem solving skills (including taking ownership to ensure timely resolution), a strong sense of urgency, keen attention to detail, and the ability to successfully execute in an environment under time and resource pressures
• Able to work both independently and in a cross-functional team environment, including with external vendors
• Detail-oriented, with good organizational, prioritization, and time management proficiencies, and able to work on multiple projects simultaneously
• Highly proficient in MS Office Suite (Word, Excel and Power Point)

Compensation

• Below is the pay range for this position that we reasonably expect to pay. Individual compensation is based on a number of factors including, experience, education and skill set, and geographic location. This range is for the San Francisco Bay Area, California location and may be adjusted to the labor market in other geographic areas. 

  Pay range: $250,000 - $300,000 per annum