Manager, Clinical Operations

The Company

With deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer. Nuvalent is an exciting early-stage company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building.

The Role

Initially reporting to the Director, Clinical Operations, the Manager, Clinical Operations will ensure excellence in clinical trial planning, execution, and data collection, in accordance with regulatory guidelines. They will be responsible for multiple aspects of clinical study conduct, including site selection, study start-up, conduct and close-out. Providing appropriate escalation of trial specific issues to deliver high quality clinical trial results. Able to adapt to changes in the work environment and manage competing demands. Nuvalent is seeking a highly motivated, patient-focused, results-orientated team member for our growing Clinical Operations organization.

Responsibilities

• Lead aspects of clinical studies and perform vendor management working under the guidance and direction of the Clinical Study and Program Lead.
• Accountable for the delivery of project(s) to achieve agreed timelines, scope, quality, and budget.
• Manage the review and approval of vendor and site contracts and budgets. Provide support and over-sight managing the creation, maintenance and close out of TMF activities.
• Ensure appropriate oversight of patient enrollment, site activation and data collection milestones.
• Support team to ensure the completeness of clinical protocol, investigator brochure, informed con-sent forms, clinical study reports and case report forms.
• Ensure site monitoring reports are accurate and thorough, reviewed on a regular basis and that metrics are being adhered to.
• Support timeline and efficient database lock by ensuring monitoring plans are in place and by participating in data review/reconciliation efforts.
• Coordinate with Clinical Supply Chain regarding drug forecasting and supply of drug
  
  

product to sites.

• Identify risks and broker solutions to facilitate clinical studies. Establish and maintain effective communication and collaboration with functional area peers and clinical trial sites to meet program objectives and support goals.
• Mentor junior team members to support development by delegating responsibilities, overseeing, and supporting clinical studies.
• Lead or co-lead department initiatives to support an expanding organization.
  
  

Competencies Include

• Detail and process orientated, with understanding of project management skills, including risk as-sessment and contingency planning.
• Excellent problem solving, communication and organization skills.
• Flexibility with changing priorities, ability to think critically, strong attention to detail, and ability to work well under pressure.
• Ability to work in a collaborative environment and build effective working relationships across the organization.
• Demonstrated leadership and ability to strategically plan, organize and manage multiple projects simultaneously.
  
  

Qualifications

• At least 3 years of Clinical Operations experience
• Bachelor’s degree or higher in a scientific or healthcare discipline preferred with 3-5 years of progressive experience in clinical research or clinical operations or related experience.
• Knowledge of ICH-GCP guidelines.
• Relevant experience managing early through late Phase clinical trials.
• Knowledge of oncology clinical trials preferred.
• Experience in managing international clinical trials preferred.
• Cross-functional leadership and communication fostering team spirit and team motivation.
• Capability to challenge status-quo using risk management approach.
• Travel may be required (10% – 15%)
  
  

Nuvalent provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to religion, race, creed, color, sex, sexual orientation, alienage or citizenship status, national origin, age, marital status, pregnancy, disability, veteran or military status, predisposing genetic characteristics or any other characteristic protected by applicable federal, state or local law.

Nuvalent is aware that many companies are dealing with fraudulent job postings on third-party employment search sites and/or individual(s) or entities claiming to be employees of such companies. Those involved are offering fraudulent employment opportunities to applicants, often asking for sensitive personal and financial information, and using such information for criminal activities.

Please be advised that all legitimate correspondence from a Nuvalent employee will come from "@nuvalent.com" email accounts. Automated system response emails from our Greenhouse applicant tracking system come from a “no-reply@greenhouse.io” email address. There are no variations of these email addresses and Nuvalent would not request personal and/or financial information via email. Job opportunities would only be extended after a completed job application is submitted by a candidate and a thorough interview process including 1:1 and/or group interviews via phone, video conferencing and/or in-person.

If you believe you have been contacted by anyone misrepresenting themselves as an employee of Nuvalent, please contact Nuvalent at 857-357-7000. Thank you.