Director – Clinical Development, Medical Monitoring

Job not on LinkedIn

🔥 0 minutes ago

🏄 California – Remote

🏄 California – Remote

💵 $187.1k - $327.5k / year

⏰ Full Time

🔴 Lead

👨‍⚕️ Medical Director

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Akero Therapeutics

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2017

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

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

• 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

• 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

• 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