[Hiring] Director of Clinical Development @Akero Therapeutics

Role Description

Reporting to the VP Clinical Development, the Director, Clinical Development will contribute to the execution of the Phase 3 clinical development programme for Efruxifermin (EFX). Key responsibilities include:

• Serve as Medical Monitor for assigned clinical trials, conducting ongoing review of emerging medical/safety data and working closely with external CRO partners.
• Play an active role in planning, conduct and evaluation of ongoing clinical trials to ensure successful execution.
• Support/manage preparation of materials for trial-related clinical committees such as Data Monitoring Committees, Adjudication 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.
• Minimum of 3 years of relevant experience in clinical development in the biotech and/or pharmaceutical industry; five (5) years preferred.
• Direct experience in executing and medical monitoring of clinical trials, experience with Phase 3 trials is highly desirable.

Requirements

• Solid knowledge of GCP, ICH guidelines and FDA/EMA/CHMP regulations, with the ability to apply these principles and standards to ensure GCP-compliant trials.
• Strong interpersonal and communication skills, with a proactive, collaborative approach.
• Skilled at searching, critically evaluating, interpreting and synthesizing scientific literature and clinical trial data.
• Demonstrated problem-solving ability and ownership of issues to drive timely resolution; adaptable, high attention to detail, and effective under time and resource constraints.
• Comfortable working independently and as part of cross-functional teams, including engagement with external vendors.
• Highly organized with strong prioritization and time-management skills; able to manage multiple projects concurrently.
• Advanced proficiency in Microsoft Office (Word, Excel, PowerPoint).
• 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.

Benefits

• The base compensation range for this position is $187,100 to $327,500.
• This position is also eligible for a company bonus based on individual and company performance.
• Long-term incentive compensation depending on the position's level or other company factors.
• Participation in Company employee benefit programs including medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program; tuition reimbursement program; and voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance.
• Time off pursuant to its sick time policy, flexible vacation policy, and parental leave policy.

Company Description

Akero Therapeutics, a Novo Nordisk company, is a clinical stage biopharmaceutical company focused on discovering and developing transformational treatments for patients with serious metabolic diseases marked by high unmet need.