Akero Therapeutics · 3 hours ago
Director /Sr. Director - Clinical Development
United States
Full-time
Remote
Lead/Staff, Director/Executive
$182K/yr - $318K/yr
3+ years expAkero Therapeutics, a Novo Nordisk company, is a clinical stage biopharmaceutical company focused on discovering and developing transformational treatments for patients with serious metabolic diseases. The Director, Clinical Development will contribute to the execution of the Phase 3 clinical development programme for Efruxifermin (EFX), playing a key role in clinical trial execution and serving as a medical expert within the organization.
BiotechnologyLife ScienceTherapeutics
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
Qualification
Required
Board Certified MD or MD/PhD or equivalent qualification with relevant medical experience
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
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)
Preferred
Experience in hepatology, MASH or internal medicine preferred
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
Benefits
Medical, dental and vision coverage
Life insurance
Disability insurance
401(k) savings plan
Flexible spending accounts
Employee assistance program
Tuition reimbursement program
Voluntary benefits such as group legal
Critical illness
Identity theft protection
Pet insurance
Auto/home insurance
Time off pursuant to its sick time policy
Flex-able vacation policy
Parental leave policy
Company
Akero Therapeutics
Akero Therapeutics is a biotechnology company focused on reversing the NASH epidemic by restoring the body’s metabolism to a balanced state.
11-50 employees
Funding
Current Stage
Public CompanyTotal Funding
$951.1MKey Investors
Pfizer Breakthrough Growth InitiativeHercules CapitalJanus Henderson Investors
2025-10-09Acquired
2024-03-05Post Ipo Equity· $366.9M
2023-05-15Post Ipo Equity· $124.2M
Leadership Team
Scott Gangloff
Chief Technology Officer
P
Patrick Lamy
Senior Vice President, Commercial Strategy
Recent News
2026-01-16
2026-01-16
2026-01-08
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