Senior Manager Clinical Operations

Senior Manager Clinical Operations

Do you want to join a team where the mission is meaningful, the challenges are complex, and you can directly see the results of your hard work? Lundbeck is a global biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases. Lundbeck employees are inspired and driven by our purpose to advance brain health and transform lives. Join us on our journey of growth! Remote Opportunity - Open to candidates anywhere in the United States

Summary: Leads the planning and execution of multicenter, potentially multinational phase 1-4 clinical studies, while contributing to broader clinical strategy and go-to-market readiness. Responsible for the project timelines, budget development and resource planning, and partners cross-functionally to ensure clinical programs are aligned with development objectives, operational excellence, and downstream commercialization needs. Ensures timely execution and completion of clinical trials while overseeing study teams and external partners to deliver high-quality clinical trials in compliance with applicable regionals and global regulations.

Essential Functions:

• Serves as the primary operational lead for assigned studies, with accountability for timelines, budgets, resource planning, and delivery of key milestones.
• Leads cross-functional Study Teams, including CRO/vendor staff, ensuring alignment of clinical execution with broader development strategy.
• Performs the facilitation, development and implementation of complex clinical trials to meet or exceed development plan timelines, and to remain on budget
• Manages study planning activities, including protocol input, timeline development, budget forecasting, and risk management, with a focus on proactive issue identification and mitigation.
• Oversees CROs and vendors to ensure high-quality, cost-effective delivery, including contract strategy, performance management, and continuous optimization of external partnerships.
• Ensures studies are conducted in compliance with global regulatory requirements (ICH GCP, CFR), applicable regional regulations, privacy laws, Lundbeck Code of Conduct, and Lundbeck SOPs, always maintaining inspection readiness.
• Contributes to inspection readiness activities, including audits and regulatory inspections, ensuring appropriate documentation, responses, and follow-up actions.
• Contributes to clinical program planning by identifying operational risks, opportunities, and efficiencies that may impact development timelines and downstream commercialization.
• Ensures timely delivery of high-quality clinical data, including oversight of safety reporting (e.g., SAE reporting compliance) and data integrity across study activities.
• Communicates study and program-level updates, risks, and insights to senior stakeholders, enabling informed decision-making across clinical and cross-functional teams.
• Contributes to cross-functional initiatives, process improvements, and organizational priorities to enhance clinical operations efficiency and effectiveness.

Required Education, Experience, and Skills:

• Accredited Bachelor's Degree
• 5+ years of experience in pharmaceutical, biotech, or CRO industry
• 3+ years of experience in clinical study management or monitoring (e.g., CRA, CTM, Study Manager)
• Demonstrated experience managing global or multicenter clinical trials
• History of managing sites in Pharma-sponsored clinical studies intended for use in NDA applications to FDA including monitoring visit scheduling, clinical site management, site training, site communication, query resolution, and generation of trip reports
• Strong knowledge of the global drug development processes and regulatory requirements (ICH GCP, CFR)
• Excellent written and verbal communication and presentation skills and ability to effectively work on remote cross-functional teams.
• Ability to lead cross-functional teams and influence without direct authority
• Strong project management skills, including planning, prioritization, and risk management
• Ability to manage multiple priorities in a fast-paced, matrixed environment

Preferred Education, Experience, and Skills:

• Accredited Master's Degree preferably in healthcare related field
• 7+ years' experience in clinical trials or related area
• Demonstrated experience managing global or multicenter clinical trials
• Strong knowledge of global drug development processes and regulatory requirements (ICH GCP, CFR)
• Experience overseeing CROs and external vendors, including performance and delivery management
• Ability to lead cross-functional teams and influence without direct authority
• Prior experience with timeline and budget development for clinical study programs including outsourced work.
• Experience preparing and conducting a variety of presentation types including management and project team updates and investigator meetings.
• Therapeutic area experience (e.g., CNS) and large molecule development
• Proficiency with clinical systems (e.g., EDC, CTMS, eTMF) and project management

Office Travel: Willingness/Ability to travel up to 30% domestically; International travel may be required.

The range displayed is a national range, and if selected for this role, may vary based on various factors such as the candidate's geographical location, qualifications, skills, competencies, and proficiency for the role. Salary Pay Range: $160,000 - $180,000 and eligibility for a 15% bonus target based on company and individual performance, and eligibility to participate in the company's long-term incentive plan. Benefits for this position include flexible paid time off (PTO), health benefits to include Medical, Dental and Vision, and company match 401k. Additional benefits information can be found on our site.

Applications accepted on an ongoing basis.