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Senior Manager, Clinical Operations Program Lead
Company | BioSpace |
Address | Massachusetts, United States |
Employment type | FULL_TIME |
Salary | |
Category | Internet News |
Expires | 2023-07-18 |
Posted at | 10 months ago |
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
- Provide operational expertise and strategic input on the development of Clinical Development Plans (CDP) supporting the clinical strategy for one or more clinical programs.
- 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.
- Lead the program-level operational strategy and planning on assigned programs in close collaboration with our strategic partners and other vendors.
- 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.
- 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.
- May participate in Business Development/in-licensing/alliances evaluations by providing operational due diligence.
- 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.
- Work with COMs, Strategic Partners/other CROs/other vendors to ensure inspection readiness.
- Contribute to functional strategic projects and process improvement.
- 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.
- Lead Clinical Operations aspects of inspection readiness activities, and act as an expert during regulatory inspections.
- Is an important contact between the strategic partners/preferred supplies and the GPT/CST.
- Be the point of escalation for the COMs for issues that can't be resolved at the study level.
- Communicate program status, cost and issues to senior management.
- 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 (e.g. End-of-Phase 2, Request for Scientific Advice Meetings).
- For certain types of studies and programs, COPL may have the following responsibilities:
- Work with Procurement, QA & Legal to qualify new clinical vendors and manage vendors for duration of a study (for vendors contracted directly with Takeda)
- 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.
- 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.
- Provide program-level direction and guidance to the COM in development of study strategy operational plans including enrolment models and risk management strategy.
- Communicate with the Global Program Leader to ensure expectations and activities are aligned.
- 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.
- 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
- Be a role model for Takeda´s values.
- Seek new ways of working to meet the needs of clinical development.
- 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.
- 8+ years' experience in pharmaceutical industry or clinical research organization, including 5+ years clinical study/project management.
- 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.
- Bachelor's Degree (Life Sciences) or international equivalent required.
- Experience must include early phase clinical studies/Phase 2 studies or later phase global/international studies or programs.
- Awareness of local country requirements is also required.
- Embody a culture of improvement and progress; promote knowledge sharing.
- Excellent matrix leadership.
- Excellence in program management, including scenario assessment, risk assessment and contingency planning.
- Requires approximately 5-20 % travel, including overnight and international travel to other Takeda sites, strategic partners, and therapeutic area required travel.
- Base Salary Range: $165,000 to $180,000. Employees may also be eligible for Short Term and Long-Term Incentive benefits. 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.
- The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.
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