Sr. Manager, Trial Deliver Leader

Role Description

The Sr. Manager, Trial Delivery Leader (TDL) is accountable for clinical trial delivery, providing operational oversight of cross-functional deliverables. The TDL leads a cross-functional trial team to build and deliver the trial operational plan, identifying and mitigating risks to effectively deliver assigned trials on time, on budget and in a compliant manner.

You will be responsible for:

• Leading the Cross Functional Trial Team (CFTT) to influence and execute delivery of the operational plan and for end-to-end trial execution.
• Accountable for overall trial delivery, budget, timelines, quality, and milestones (e.g., support DBL / CSR / TLR planning and scope, define protocol deviations and resolution pathways).
• Proactively ensuring that trial deliverables and milestones are met.
• Identifying risks and ensuring mitigation and contingencies are being initiated and followed through.
• Ensuring trial is operationalized in compliance with global health authority regulations and guidelines and internal operating procedures and processes.
• Accountable for identifying risks in study conduct, developing mitigation plans and escalating concerns to the CT or CDT.
• Participating in preparation for, and conduct of, Health Authority inspections and internal QA audits.
• Ensuring that the trial team operates in a constant state of inspection-readiness, collaborating with R&D Quality to ensure quality oversight.
• Participating in process improvement activities at a trial, compound & cross-DU level, as needed.

Additional Responsibilities may Include:

• Leading and ensuring inspection readiness for program through risk identification and readiness review.
• Providing leadership during Health Authority inspections and on the identification of risks and mitigation plans at the program level for key issues.
• Mentoring & supporting onboarding of new team members, particularly those in Trial Management.
• Fostering employee engagement, inclusion, and Credo Behaviors.

Qualifications

• Bachelor's degree is required. Preferred areas of study include Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy).
• Minimum of 8 years in Pharmaceutical, Healthcare or related industries.
• Minimum 2 years’ experience leading multiple aspects of a global clinical trial.
• Experience in and knowledge of the pharmaceutical development process.
• Clinical research operational knowledge and experience across multiple phases of studies (Phase I-IV); must have the ability to manage all aspects of execution of a clinical trial.
• Must possess excellent leadership skills and proven ability to foster team productivity and cohesiveness.
• Experience of leading without authority and in multi-functional matrixed and global environments.
• Excellent decision-making, analytical and strong financial management skills are essential to this position.
• Operate and execute with limited supervision.
• Experience mentoring/coaching others.
• Strong project planning/management, communication and presentation skills are required.
• Travel up to 15-20% of the time, defined by business needs.

Requirements

• The anticipated base pay range for this position in the US is $137,000 - $235,750.
• The compensation and benefits information set forth in this posting applies to candidates hired in the United States.
• Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
• The Company maintains highly competitive, performance-based compensation programs.
• This position is eligible for an annual performance bonus in accordance with the terms of the applicable plan.
• Bonuses are awarded at the Company’s discretion on an individual basis.

Benefits

• Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
• Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
• Employees are eligible for the following time off benefits:
• Vacation - up to 120 hours per calendar year.
• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year.
• Holiday pay, including Floating Holidays - up to 13 days per calendar year.
• Work, Personal and Family Time - up to 40 hours per calendar year.