Note: The job is a remote job and is open to candidates in USA. Akero Therapeutics, a Novo Nordisk company, is a clinical stage biopharmaceutical company focused on discovering and developing transformational treatments for patients with serious metabolic diseases. The Senior Director, Clinical Data Management provides strategic leadership and oversight for all clinical data management activities across the development program, ensuring data integrity and supporting timely, high-quality decision making.
Responsibilities
- 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
- Ensure that reporting personnel have individual development plans (IDP), with annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process
- Manage the application and communication of all company policies and procedures
Skills
- Bachelor's degree required
- 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
- 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
- Master's degree in Life Sciences or a related discipline highly preferred
- At least four years of management experience within pharmaceutical development is preferred
Benefits
- Company bonus based on individual and company performance
- Long-term incentive compensation depending on the position's level or other company factors
- 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
- Flex-able vacation policy
- Parental leave policy
Company Overview
Company H1B Sponsorship