Director /Sr. Director - Clinical Development

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, 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 (Senior) Director, Clinical Development is expected to play a key role in contributing to the upcoming BLA submission. They 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.

Open to hiring at the Senior Director level commensurate with experience

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
• 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 Phase III clinical trials, including medical monitoring responsibilities
• Relevant experience:
  • 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.
  • Proven experience authoring or overseeing regulatory documents, including protocols, clinical study reports (CSRs) and briefing packages.
  • 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, detail-focused, 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
• Experience in Hepatology, Gastrointestinal, Endocrinology or related field, preferred.

The base compensation range for this position is $181,670 to $317,920. Base compensation is determined based on a number of factors. This position is also eligible for a company bonus based on individual and company performance.

Akero Therapeutics, a Novo Nordisk company, offers long-term incentive compensation depending on the position's level or other company factors.

Employees are also eligible to participate 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. The Company also offers time off pursuant to its sick time policy, flex-able vacation policy, and parental leave policy.

The job posting is anticipated to close on February 6, 2026. The Company may however extend this time-period, in which case the posting will remain available on our careers website at https://akerotx.com/job-opportunities.

EEO Statement:

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

Originally posted on Himalayas