Sr. Director, Clinical Data Management

Akero Therapeutics is developing medicines that deliver transformational outcomes to patients with serious metabolic diseases. Our lead clinical program, Efruxifermin (EFX), is a treatment for non-alcoholic steatohepatitis (NASH), rapidly emerging as the leading cause of liver disease around the world. Efruxifermin is a novel long-acting fibroblast growth factor 21 (FGF21) agonist, with the potential to substantially improve the lives of patients with NASH, and other serious metabolic diseases.

 

We are a team of problem solvers dedicated to pursuing bold scientific approaches to build a brighter future for patients. Our diverse skill sets and backgrounds, desire to learn from each other and collaborative spirit breed a culture where everyone feels inspired to bring their best thinking to work, and to bring out the best in others.

 

The Senior Director, Clinical Data Management is a key member of Clinical Development and will closely partner with the Head of Development Operations.  The Senior Director of Clinical Data Management provides strategic leadership and oversight for all clinical data management activities across the development program. This role partners closely with leaders from Clinical Operations, Biostatistics, Regulatory, Medical, and other functional areas to proactively solve cross-functional challenges, ensure data integrity, and support timely, high-quality decision making. The Senior Director is accountable for end-to-end vendor oversight, data governance, and the delivery of reliable, inspection-ready clinical data.

Reports to the VP, Clinical Research and Medical Affairs.  Manages a team of clinical data management professionals.

 

The position will interact with all areas of Clinical and Regulatory Affairs within Akero Therapeutics and Novo Nordisk.  The position interacts with team members at the IC through Vice President level.  The position requires experience interacting with senior level positions in each of these departments and a good understanding of how these peer teams operate, ideally through experience working within these teams (broad experience).

 

Externally, the position will engage with CROs and CMOs

Job 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

Development of People:    
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.

Qualifications

• 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

 

The base compensation range for this position is $187,000 to $279,800. Base compensation is determined based on a number of factors. This position is also eligible for a company bonus based on individual and company performance.  

Akero Therapeutics, a Novo Nordisk company, offers long-term incentive compensation depending on the position's level or other company factors.  

Employees are also eligible to participate in Company employee benefit programs including medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program; tuition reimbursement program; and voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance. The Company also offers time off pursuant to its sick time policy, flex-able vacation policy, and parental leave policy.

 

The job posting is anticipated to close on July 24, 2026. The Company may however extend this time-period, in which case the posting will remain available on our careers website at https://akerotx.com/job-opportunities.

 

EEO Statement:

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.