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 an Senior Manager, Clinical Operations Program Lead based in our Cambridge/Lexington office or remotely reporting to the Clinical Operations Leadership team.
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 accomplish their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, 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 provide Better Health and a Brighter Future to people around the world.
Here, you will be an important contributor to our inspiring, bold mission.
- Provide operational expertise and strategic input on the development of Clinical Development Plans (CDP) supporting the clinical strategy for one or more clinical programs.
- Lead the program-level operational strategy and planning on assigned programs in close collaboration with our strategic partners and other vendors.
- Provide program-level sponsor's operational oversight of our strategic partners and other vendors to ensure the development of the clinical studies on time, and within agreed budget.
- Represent Clinical Operations at the Global Program Team (GPT) and partner with Global Clinical Lead to lead the Clinical Sub Team (CST) accountable for completing the CDP.
- Accountable to the GPT for translating the CDP into an operational strategy and plan. Ensure assessment of multiple operational scenarios for execution of the CDP.
- Partner with the CST to develop high-quality study synopsis/protocol by providing operational input and by ensuring all relevant partners are involved and contributing.
- Work with early or late phase COPL counterpart to ensure agreement and seamless interactions with the GPT.
- Communicate with the Global Program Leader to ensure expectations and activities are aligned.
- Lead the early or late phase clinical program operational strategy and planning on assigned clinical programs in close collaboration with the Clinical Operations Managers (COMs), our strategic partners/other CROs, other vendors, and with the CST.
- Perform program-level oversight of our strategic partners and other vendors to ensure the operational execution and delivery of the assigned clinical programs in compliance with quality standards (including ICH GCP, local regulations and Takeda SOPs), and on budget.
- Work with COMs and counterparts to oversee the performance for all activities assigned to our strategic partners/other CROs/other vendors, including escalation of issues to governance committees and to senior management when warranted.
- Oversee clinical program budget planning and accountable for external spend related to clinical program execution. Work with COMs, Global Program Management (GPM), Outsourcing Management, and Finance to ensure that budgets, enrolment, and gaiting are accurate.
- Communicate program status, cost and issues to senior management.
- Provide program-level direction and guidance to the COM in development of study strategy operational plans including enrolment models and risk management strategy.
- Be the point of escalation for the COMs for issues that can't be resolved at the study level.
- May participate in Business Development/in-licensing/alliances evaluations by providing operational due diligence.
- Review and provide expert clinical operations input into clinical documents related to the drug development process including Investigator Brochures, Investigational New Drug Applications (INDs) and Investigational Medicinal Product Dossier (IMPDs), study synopsis & protocols, clinical study reports, applicable sections of the New Drug Application (NDA) and Marketing Authorization Application (MAA), updates to IND and NDA documents, DSURs and other safety reports; Provide expert clinical operations input into preparation for important regulatory meetings (eg End-of-Phase 2, Request for Scientific Advice Meetings).
- Work with COMs, Strategic Partners/other CROs/other vendors to ensure inspection readiness.
- Lead Clinical Operations aspects of inspection readiness activities, and act as an expert during regulatory inspections.
- Contribute to functional strategic projects and process improvement.
- Seek new ways of working to meet the needs of clinical development.
- Be a role model for Takeda´s values.
- For certain types of studies and programs, COPL may have the following responsibilities:
- Is an important contact between the strategic partners/preferred supplies and the GPT/CST.
- Provide program and study-level direction to the strategic partners/preferred suppliers to develop study strategy operational plans including enrolment models and risk management strategy.
- Perform site feasibility/capability assessments for programs/studies requiring specialized experimental tests and technologies and work with internal experts and sites to ensure successful operational outcomes
- Work with Procurement, QA & Legal to qualify new clinical vendors and manage vendors for duration of a study (for vendors contracted directly with Takeda)
EDUCATION AND EXPERIENCE:
- Bachelor's Degree (Life Sciences) or international equivalent required.
- 8+ years' experience in pharmaceutical industry or clinical research organization, including 5+ years clinical study/project management.
- Experience must include early phase clinical studies/Phase 2 studies or later phase global/international studies or programs.
- Experience in more than one therapeutic area.
- Expertise in global regulatory and compliance requirements for clinical research, including US CFR, EU CTD, and ICH GCP.
- Awareness of local country requirements is also required.
- Excellence in program management, including scenario assessment, risk assessment and contingency planning.
- Excellent Matrix leadership.
- Embody a culture of improvement and progress; promote knowledge sharing.
- Fluent business English.
- Requires approximately 5-20 % travel, including overnight and international travel to other Takeda sites, strategic partners, and therapeutic area required travel.
- In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.
- Base Salary Range: $160,000.00 to $180,000.00, 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 posting is made in compliance with Colorado's Equal Pay for Equal Work Act, C.R.S. § 8-5-101 et seq.
- This position is currently classified as "remote" in accordance with Takeda's Hybrid and Remote Work policy.
Empowering Our People to Shine
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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