Director – Clinical Development, Medical Monitoring

Akero Therapeutics

Clinical development director advancing Akero’s MASH treatment, efruxifermin, through Phase 3 trials. Leading medical monitoring, regulatory submissions, data analysis, and scientific disclosures.

Posted 8/20/2026full-timeRemote • California • 🇺🇸 United StatesLead💰 $187,100 - $327,500 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in medical monitoring and clinical trial management, with a strong foundation in regulatory compliance and scientific data evaluation. Proven ability to build professional relationships and effectively communicate with cross-functional teams and external stakeholders.

Highest-signal resume keywords

Board Certified MD or MD/PhDClinical Trial ManagementGCP and ICH Guidelines KnowledgeMedical Monitoring ExperienceRegulatory Submission Preparation

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical DevelopmentData Monitoring CommitteesScientific Literature EvaluationProblem-SolvingAttention to DetailProject ManagementBLA/NDA/MAA Submission PreparationPhase 3 Clinical Trial ExperienceRegulatory Path KnowledgeHepatology or Internal Medicine Experience

Soft Skills

Interpersonal SkillsCommunication SkillsCollaborative ApproachAdaptabilityTime Management

Tools & Technologies

Microsoft Office (Word, Excel, PowerPoint)

Certifications & Qualifications

Board Certified MD or MD/PhD

Industry Keywords

Biotech IndustryPharmaceutical IndustryFDA RegulationsEMA RegulationsCHMP Regulations

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Serve as Medical Monitor for assigned clinical trials, conducting ongoing review of emerging medical and safety data and working closely with external CRO partners
Play an active role in planning, conducting and evaluating ongoing clinical trials
Support or manage preparation of materials for trial-related clinical committees, including Data Monitoring Committees and Adjudication Committees
Contribute to planning, authoring and critical review of documents submitted to regulatory authorities and ethics committees/IRBs, including protocols, CSRs, Investigator’s Brochures, DSURs, clinical briefing documents and BLA/MAA submission components
Contribute to strategic planning, authoring and critical review of scientific data disclosures, including slide presentations, posters and publications
Develop professional relationships with external clinical opinion leaders, investigators and consultants
Stay abreast of competitive intelligence and market/industry activities
Engage with external stakeholders such as vendor thought leaders and serve as primary liaison with assigned individuals or groups
Represent clinical development at internal cross-functional and external meetings
Perform other duties related to clinical development of EFX as assigned

Requirements

What you’ll need

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
Direct experience in executing and medical monitoring of clinical trials
Solid knowledge of GCP, ICH guidelines and FDA/EMA/CHMP regulations
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 in hepatology, MASH or internal medicine preferred
Phase 3 clinical trial experience highly desirable
Experience with preparation of documentation for BLA/NDA/MAA submissions desirable
Knowledge of the regulatory path across various health authorities desirable

Benefits

Comp & perks

Company bonus based on individual and company performance
Long-term incentive compensation
Medical coverage
Dental coverage
Vision coverage
Life insurance
Disability insurance
401(k) savings plan
Flexible spending accounts
Employee assistance program
Tuition reimbursement program
Group legal benefit
Critical illness benefit
Identity theft protection
Pet insurance
Auto/home insurance
Sick time
Flexible vacation policy
Parental leave policy