Senior Director, Clinical Data Management

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🔥 0 minutes ago

🏄 California – Remote

🏄 California – Remote

💵 $187k - $279.8k / year

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical 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

• Serve as a senior thought partner to functional leaders, contributing to program-level planning, risk mitigation, and execution strategies. • Collaborate across Clinical Operations, Biostatistics, Medical, Regulatory, Safety, and Quality to identify and resolve data-related issues impacting timelines, quality, or compliance • Set up data management vendors as required, including authoring of RFPs, reviewing and negotiating data management budgets and contracts • Oversee database status with respect to key performance indicators, metrics, and program level deliverables and timelines to support program timelines • Oversee data review, cleaning, and database lock activities to ensure accuracy and readiness for analysis and regulatory submission • Proactively identify vendor risks, escalate issues as needed, and drive root-cause analysis and corrective actions • Balance quality, timelines, and cost while driving pragmatic solutions aligned with program priorities • Foster a culture of accountability, collaboration, and continuous improvement across internal teams and external partners • Provide direct supervision and periodic review of work for departmental employees, to ensure oversight and execution of clinical development timelines • Direct and mentor a team of data management professionals. • Foster a collaborative environment that encourages innovation and knowledge sharing. • Ensure effective resource allocation and management across research departments. • Drive performance and accountability through clear communication of expectations and goals • Support organizational growth by scaling data management capabilities and processes as the portfolio evolves

🎯 Requirements

• Bachelor's degree required; Master's degree in Life Sciences or a related discipline highly preferred. • Minimum of 12 years of experience in clinical development within the pharmaceutical or biotechnology industry, including significant experience as a hands-on clinical data management lead. At least four years of management experience within pharmaceutical development is preferred. • Strong understanding of drug development, FDA regulations, and ICH GCP guidelines, with thorough knowledge of the pharmaceutical industry and the conduct of global clinical studies. • Demonstrated leadership and people-management experience, with a proven track record of leading cross-functional and international teams and influencing senior leaders across functions. • Experience managing clinical data management vendors, contractors, and service providers to ensure delivery of program objectives and timelines. • Strong analytical skills with demonstrated experience gathering, interpreting, and analyzing clinical research and drug development data to support decision-making and risk management. • Excellent communication, presentation, and stakeholder-management skills, with the ability to translate complex data and risks into clear, business-relevant insights. • Understanding of FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies required

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