Are you looking for a patient-focused company to inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Director, COM Manager reporting to the Head, Clinical Trial Management based in our Cambridge/Lexington office or remotely.
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to work towards their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, and work toward excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Here, you will be an important contributor to our inspiring, bold mission.
- Oversee direct line management of Clinical Operations Managers (COMs) for a given therapeutic area with clinical studies of high complexity and high risk.
- Align with Clinical Operations Program Leads (COPLs) for a given therapeutic area to define COM support needs and define resourcing plan.
- Ensure appropriate training of COMs to deliver operational consistency and support across clinical trial programs.
- Help complete studies in a Matrix management structure to ensure compliance with quality standards (including ICH GCP, local regulations and Takeda SOPs), and on budget.
- Provide management of COMs within assigned TA, including hiring/staff selection and assignment of individual studies, resource allocation, onboarding, overall training, completion of goals, development plans, performance reviews, and Talent Management.
- Oversee management of COMs with clinical studies of high complexity and high risk, eg multiple indications, data safety monitoring boards or endpoint review committees, interim analyses, requiring the coordination of multiple vendors, or other special assessments.
- Ensure allocation of COMs across all Takeda clinical programs, based on experience and study complexity, following Takeda's strategic goals and Clinical Development Plan.
- Overseeing COMs according to needs of Clinical Operations Program Leads to ensure execution of assigned studies.
- Ensure compliance of assigned staff to Takeda SOPs and training of systems and quality standards, including inspection readiness in execution of Takeda studies and trials.
- Contribute to departmental long-range resource forecasting and strategies.
- Coach Clinical Operation Managers and new hires in navigating career progression options within Takeda.
- Oversee onboarding, systems access, and mentoring of new COM Managers.
- Lead direct reports, ensuring employees follow corporate policies and following up with management.
- Ensure compliance with pre-defined roles and responsibilities within a Matrix management structure.
- Contribute to Clinical Operations functional level resource evaluations for study and program management (in collaboration with Sr Director/Director, Clinical Operations) to ensure resources are available for delivering clinical programs.
- Be an ongoing liaison through the relevant COPL with the clinical study teams, and provide feedback regarding corporate goals and the performance of direct reports.
- May provide TA-level direction and contribute directly to due diligence projects across the therapeutic area, and may assist the Head of COM Management.
- Maintain a positive work environment, building partnerships and modeling teamwork, communicating to the teams and partners in an open, balanced, and objective manner.
- Lead Clinical Operations projects (including lessons learned/best practices process) to develop creative processes and technologies to grow operations and reduce operating costs; Support functional projects.
- Foster knowledge sharing and the use of best practices across the COM team and acts as team superuser or subject matter expert for our processes.
- Directly support Clinical Operations Program Leads in daily activities for complex or business-critical clinical studies (including providing clinical study management expertise, study and CRO oversight, issue escalation, and resolution).
EDUCATION AND EXPERIENCE:
- Bachelor's Degree or international equivalent required, Life Sciences preferred. Advanced degree is desirable.
- 12+ years experience in the pharmaceutical industry or clinical research organization, including 9+ years in clinical study management/oversight.
- 4+ years of line management experience including management of staff with oversight of therapeutic area development teams (matrix organization) and management of staff across multiple sites/regions.
- Experience in global setting required, including ability to collaborate with colleagues in other locations.
- Experience in people leadership, managing global teams, and coordinating collaboration with teams.
- Operational experience in pharmaceutical drug development with direct exposure to clinical development.
- Health care business acumen with a comprehensive understanding of the pharmaceutical industry.
- In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.
- Base Salary Range: $190,000.00 to $220,000.00, based on candidate professional experience level. Employees may also be eligible for Short Term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off.
- This position is currently classified as "remote" in accordance with Takeda's Hybrid and Remote Work policy.
- This posting is made in compliance with Colorado's Equal Pay for Equal Work Act, C.R.S. § 8-5-101 et seq.
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations
Massachusetts - Virtual Worker Type
Employee Worker Sub-Type
Regular Time Type