Offer summary

Qualifications:

Advanced degree in life sciences (MS or PhD)., At least 8 years of industry experience in clinical research., Experience with regulatory filings such as NDA or BLA., Prior experience in hepatology, gastrointestinal, or related fields is preferred..

Key responsibilities:

Provide scientific input across clinical development activities.

Ensure scientific rigor in clinical trial design and data interpretation.

Contribute to the preparation of clinical and regulatory documents.

Engage with external thought leaders and support conference activities.

Job description

COMPANY BACKGROUND

Akero Therapeutics is a clinical stage biopharmaceutical company focused on discovering and developing transformational treatments for patients with serious metabolic diseases marked by high unmet need. Our current focus is on advancing our lead program efruxifermin (EFX) to provide a powerful new treatment for patients with MASH(metabolic dysfunction-associated steatohepatitis).

We are a team of problem solvers dedicated to pursuing bold scientific approaches to build a brighter future for patients. Our diverse skill sets and backgrounds, desire to learn from each other and collaborative spirit breed a culture where everyone feels inspired to bring their best thinking to work, and to bring out the best in others.

Job Summary

Provide broad scientific input to activities that span clinical development and scientific affairs, including clinical strategy, protocol development, data review and analysis, reporting of results, regulatory documents, and externally facing activities including data dissemination, thought leader engagement, KOL insights, and external research initiatives. Represent clinical research / scientific affairs at internal and external forums as appropriate.

Job Responsibilities

Translate concepts/strategies into specific objectives and activities to effectively achieve goals
Ensure appropriate scientific rigor in the design, conduct, validity and interpretation of clinical trials to support regulatory applications or business objectives.
Contribute to the strategic planning, authoring as needed, and review of clinical and regulatory documents including protocols, CSRs, IBs, regulatory briefing packages or regulatory filing documents supporting BLA
Liaise with internal (Clinical operations team) and external partners (e.g. CROs, vendors) as needed to ensure appropriate study execution and data collection
Contribute as the clinical point person to cross-functional teams including support of CMC activities, regulatory interactions and other business-critical needs
Other activities related to clinical development of EFX
Contribute to development and execution of publication plan to ensure strategic data disclosures aligned with company key messages and supported by clinical data
Execute on data mining efforts to address data gaps or generate value added abstracts / publications
Engage with thought leaders in NASH to ensure awareness of Akero data among key NASH experts and solicit feedback into the EFX development program
Contribute to conference planning and presentations

Technical Requirements and Skills

Prior experience with regulatory filings including NDA or BLA in US / EU / other regions preferred
Strong interpersonal and communication skills; proactive approach.
Able to work both independently and in a team environment.
Detail-oriented, with good organizational, prioritization, and time management proficiencies. Must be able to work on multiple projects simultaneously.
Expertise in navigating scientific literature, interpretation of data, display of 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.
General familiarity with biostatistics
Highly proficient in standard computer software (Word, Excel and Power Point).
Ability to travel, in some cases, internationally

Qualifications

Advanced scientific degree in life sciences (MS or PhD) with 8 years or more direct biotechnology or pharmaceutical industry experience in clinical research.
Experience in multiple therapeutic areas, with prior experience in Hepatology, Gastrointestinal or related field, preferred.
Prior industry experience in contributing to the preparation of clinical protocols, study reports, IND, IB, regulatory briefing packages and / or NDA/CTD documents highly desirable.
Prior industry experience supporting Medical Affairs and Commercial activities highly desirable.

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: $230,000 - $250,000 per annum

Special Advisory

Akero will not conduct interviews via text message or messaging platforms. Please be vigilant in checking that the communication is, in fact, coming from Akero. If you are contacted by any individual or group using email addresses or other contact information that incorporates “akerotx” but do not use our exact domain, akerotx.com, please submit a report to the FTC.

Required profile