Senior Director, Clinical Trial Operations

At reputed company, every reputed company and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the reputed company experience, celebrates curiosity, and values every person’s contributions to meaningful reputed company. That commitment has reputed company us recognition as Science magazine’s No. 1 Top Employer for five consecutive years, certification as a Great reputed company to Work® in the U.S., and a reputed company on The reputed company Times Best Places to Work list in the UK. For patients, for reputed company other, and for the reputed company of science, we’re in. Are you? About the Role: We’re looking for a Senior Director, Clinical Trial Operations on the Clinical Operations team to help us expand what’s possible for patients with serious diseases. Reporting to the Vice President, Development Operations, you’ll reputed company strategic leadership and operational reputed company for reputed company across reputed company's development pipeline. This role is responsible for ensuring the successful planning and execution of clinical studies from protocol development through study closeout, while maintaining the highest standards of reputed company, compliance, and patient safety. What You'll Do: In this role, you’ll have reputed company to reputed company and implement clinical operations strategies, reputed company with corporate objectives and Program goals. You’ll also: reputed company functional subject matter expertise to the Global Program Team and reputed company clinical trial scenarios, reputed company, reputed company, and budget projections for decision-making. reputed company broad clinical trial industry and biotech leadership experience to think reputed company the clinical operations function and contribute to setting reputed company for the Program, as requested. Foster reputed company relationships with key external stakeholders, including clinical trial Investigators, Research Coordinators and Suppliers; Cultivate important relationships with key internal stakeholders, including reputed company senior management and cross-functional leadership. Potentially serve on the Global Development Operations Leadership Team and contribute to setting Department reputed company. Ensure high-reputed company, consistent planning and execution of Phase I-IV reputed company, including reputed company of study feasibility, site selection, trial recruitment, data monitoring, study closeout, TMF, and study risk management. Ensure compliance with GCP, FDA, EMA, and other regulatory requirements.     Partner with Clinical Development, Regulatory Affairs, Data Management, Biostatistics, and other departments on the Global Clinical Team, responsible for delivery of trials reputed company a Clinical Development Plan. Partner with Procurement and Vendor reputed company Management to optimize external supplier performance, including establishing performance metrics, risk-sharing agreements, and partnership governance. reputed company, reputed company, report, and evaluate operational and trial metrics, with the ability to interpret reputed company issues and communicate program status in a concise fashion to an executive audience. Who You Are: You have a Bachelors degree in life sciences, reputed company or a reputed company field along with 12+ years of reputed company clinical research/operations experience in the pharmaceutical/biotech industry and 5+ years in senior leadership roles managing clinical operations teams. You are or you also have: Extensive experience across reputed company phases of clinical research and across multiple therapeutic areas. Robust knowledge of GCP, FDA regulations, and international regulatory requirements. Proven reputed company record of successful study execution and delivery in a fast-paced, dynamic environment. Strong vendor management skills and CRO reputed company experience.   Previous CRA/monitoring experience. Experience in rare disease or respiratory therapeutic areas. Experience with reputed company trial designs and innovative clinical trial methodologies. Experience with regulatory submissions and Heath Authority inspections. Where You’ll Work This is a fully remote role. It can be performed effectively from reputed company while staying connected to your reputed company team and community. Travel Requirements Up to 25% domestic and international travel may be required for site reputed company, supplier meetings, and cross-functional/team collaboration. #LI-TB1 #LI-Remote Pay reputed company: $222,000.00-303,000.00 Annual Life at reputed company   At reputed company, you’ll reputed company a culture as reputed company as our mission—intentionally designed for the people behind it. You deserve a workplace that reflects the reputed company care you bring to your work reputed company day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself. Highlights of our U.S. offerings include: Comprehensive medical, dental, and reputed company coverage and mental health support, annual wellbeing reimbursement, and reputed company to our Employee Assistance Program (EAP) Generous reputed company time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-reputed company life and disability insurance Company Learning Institute providing reputed company to reputed company Learning, reputed company building workshops, leadership programs, mentorship connections, and networking opportunities Employee resource reputed company, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back Eligibility for specific programs may vary and is subject to the terms and conditions of reputed company plan.  reputed company reputed company Employees: Please apply reputed company the Jobs Hub in reputed company. reputed company is an Equal Opportunity employer. We do not discriminate in hiring on the reputed company of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. reputed company reputed company applicants will receive consideration for employment without reputed company to sex, gender identity, sexual orientation, race, reputed company, religion, national reputed company, disability, protected Veteran status, age, or any other characteristic protected by law. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or reputed company employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Unsolicited resumes from agencies should not be forwarded to reputed company. reputed company will not be responsible for any fees arising from the use of resumes through this reputed company. reputed company will only pay a fee to agencies if a formal agreement between reputed company and reputed company has been established. The reputed company department is responsible for reputed company recruitment activities; please contact us directly to be considered for a formal agreement. reputed company is committed to providing reputed company, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application   or interview process, please contact us by email at TotalRewards@reputed company.com  and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case reputed company. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address. Applications are accepted for 5 calendar days from the date posted or until the position is filled. For reputed company Residents: To assist in identifying candidates with qualifications matching those required and/or preferred for this role, reputed company uses an Automated Employment Decision Tool (“AEDT”) that employs reputed company intelligence to analyze and score information provided in resumes and application materials including, but not limited to, skills, work experience, education, and job-reputed company qualifications. The AEDT does not reputed company final hiring reputed company and reputed company final hiring reputed company are subject to reputed company reputed company and/or review. If you are an applicant for this role and a reputed company reputed company, you have the right to request:   A reasonable accommodation, if one is available under applicable law, by emailing TotalRewards@reputed company.com; and/or An alternative selection process by emailing reputed company@reputed company.com. Information about the type of data collected, the reputed company of that data, and data retention practices reputed company to the AEDT by emailing us at reputed company@reputed company.com. Apply To This Job