Akero Therapeutics

Restoring Balance. Renewing Life.

Principal Clinical Scientist – Clinical Development

Clinical ResearchClinical ResearchFull TimeRemoteTeam 11-50Since 2017H1B No SponsorCompany SiteLinkedIn

Location

United States

Posted

43 days ago

Salary

$148.3K - $259.5K / year

Postgraduate Degree5 yrs expEnglish

Job Description

• 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.

Job Requirements

  • 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
  • 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 and auto/home insurance
  • time off pursuant to its sick time policy
  • flexible vacation policy
  • parental leave policy

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