Clinical Operations Program Leader II/ Clinical Program Manager/Clinical Operations/Clinical Development
Title: Clinical Operations Program Leader II
Location: Cambridge, MA
Duration: 6 months
Function: Oncology Global Development Operations Department: Late Clinical Operations
Intro: The Clinical Operations Program Leader II will provide operational expertise and strategic input to the development of Early Clinical Research Plans (ECRP) and/or Clinical Development Plans (CDP) supporting the overall clinical strategy for one or more clinical programs
- Develop and 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 effective execution of the clinical studies on time, with high quality and within agreed budget.
- Represent Clinical Operations (Early or Late) at the Global Program Team (GPT) and partner with Translational Clinical Lead/Global Clinical Lead and Global Program Manager to lead the Clinical Sub Team (CST) accountable for the development and execution of the ECRP and/or CDP.
Accountabilities: Accountable to the GPT for the translation of the ECRP and/or CDP into an optimal operational strategy and plan. Ensures assessment of various scenarios for optimal execution of the CDP.
- Partner with the CST to develop high quality study synopsis/protocol by providing operational input and by ensuring all relevant stakeholders (both internal and external) are involved and contributing.
- Collaborate with early or late phase COPL counterpart to ensure alignment and seamless interactions with the GPT.
- Maintain close communication with the Global Program Leader to ensure expectations and activities are aligned.
- Develop and lead the Early or Late Phase Clinical Program Operations strategy and planning on assigned clinical programs in close collaboration with 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 overall operational execution and delivery of the assigned clinical programs in compliance with quality standards (including ICH GCP, local regulations and Takeda SOPs), on schedule and on budget.
- Collaborate with cross-functional 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.
- Responsible for clinical program budget planning and accountable for external spend related to clinical program execution. Works closely with strategic partners, other vendors, Global Program Management (GPM), Outsourcing Management, and Finance to ensure on a regular basis that budgets, enrolment, and gaiting are accurate.
- Communicates program status, cost and issues to ensure timely decision-making by senior management.
- Provide program-level direction and support to the Associate Program Leader (APL) in the development of study strategy operational plans including enrolment models and risk management strategy.
- 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/or Investigational Medicinal Product Dossier (IMPDs), study synopsis & protocols, clinical study reports, applicable sections of the New Drug Application (NDA) and/or Marketing Authorization Application (MAA), updates to IND and NDA documents, DSURs and other safety reports; Provide expert clinical operations input into preparation for key regulatory meetings (e.g. End-of-Phase 2, Request for Scientific Advice Meetings, etc.), as appropriate.
- Collaborate with Strategic Partners/other CROs/other vendors to ensure inspection readiness.
- Bachelors Degree or international equivalent required, Life Sciences preferred
- 6+ years experience in pharmaceutical industry and/or clinical research organization, including 3+ 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 is advantageous.
- Knowledge in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH GCP. Awareness of local country requirements is a plus.
- Requires approximately 5-20 % travel, including overnight and international travel to other Takeda sites, strategic partners, and therapeutic area required travel.
Sthree US is acting as an Employment Business in relation to this vacancy.