Akero Therapeutics · 4 hours ago
Principal Clinical Scientist - Clinical Development
United States
Full-time
Remote
Senior Level, Lead/Staff
$148K/yr - $260K/yr
5+ years expAkero Therapeutics, a Novo Nordisk company, is a clinical stage biopharmaceutical company focused on developing treatments for serious metabolic diseases. The Principal Clinical Scientist will contribute to the Phase 3 clinical development program for EFX, engaging in clinical protocol development, medical monitoring, data analysis, and regulatory submissions.
BiotechnologyLife ScienceTherapeutics
Responsibilities
Play an active role in planning, conduct and evaluation of ongoing clinical trials to ensure successful execution
Support medical monitoring activities for ongoing clinical trials
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, IB, clinical briefing documents)
Contribute to the strategic planning, authoring, and critical review of scientific data disclosures (e.g., slide presentations, posters and publications)
Co-ordinate aggregate report preparation (e.g., DSURs, PSUSARs, ASR), and safety management plans (SMPs) in collaboration with external vendors
Contribute to engagement with external stakeholders such as vendors, 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 research at internal cross-functional or external meetings
Other duties related to clinical development of EFX as assigned
Qualification
Required
PhD, PharmD or other qualification with relevant professional experience, (e.g. RN, NP, PA)
At least 5+ years of relevant experience in clinical development in the biopharmaceutical industry
Direct experience of Phase 3 clinical trial execution and medical monitoring support
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 data
Demonstrated problem solving skills (including taking ownership to ensure timely resolution), a strong sense of urgency, flexibility, 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 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)
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
H1B Sponsorship
Akero Therapeutics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
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
Company data provided by crunchbase