Director, Clinical Development

Job not on LinkedIn

🕒 January 28

🏄 California – Remote

🏄 California – Remote

💵 $181.7k - $317.9k / year

⏰ Full Time

🟠 Senior

👔 Director

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Akero Therapeutics

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2017

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Akero Therapeutics is a company pioneering novel therapies to transform the lives of people living with serious metabolic diseases. Their flagship program, Efruxifermin (EFX), is aimed at treating metabolic dysfunction-associated steatohepatitis (MASH) and is currently undergoing multiple clinical trials. Akero is committed to advancing medicine in the field of metabolic diseases and has a strong focus on research, development, and clinical studies.

📋 Description

• 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 • Support/manage preparation of materials for trial-related clinical committees • Contribute to planning, authoring, and critical review of documents submitted to regulatory authorities • Contribute to the strategic planning, authoring, and critical review of scientific data disclosures • Develop professional relationships with external clinical opinion leaders, investigators, and consultants • Contribute to engagement with external stakeholders • 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 as assigned

🎯 Requirements

• Board Certified MD or MD/PhD or equivalent qualification with relevant medical experience • Experience in hepatology, MASH or internal medicine preferred • 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 • Proven experience authoring or overseeing regulatory documents • Strong interpersonal and communication skills • Skilled at searching, critically evaluating, interpreting and synthesizing scientific literature and clinical trial data • Demonstrated problem-solving ability and ownership of issues • Comfortable working independently and as part of cross-functional teams • Highly organized with strong prioritization and time-management skills • Advanced proficiency in Microsoft Office (Word, Excel, PowerPoint) • 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