Clinical Operations Program Leader II
A pharmaceutical corporation sitting in Massachusetts is seeking to hire a Clinical Operations Program Leader for their Oncology Global Development Operations. This individual will be working within late phase clinical operations.
The Clinical Operations Program Leader II will be responsible for: 1) Accountable to the Global Program Team for the translation of the Early Clinical Research Plan and/or Clinical Development Plans into an optimal operational strategy and plan. 2) 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, on schedule and on budget. 3) Responsible for clinical program budget planning and accountable for external spend related to clinical program execution. 4) 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. 5) Performs site feasibility/capability assessments for programs/studies requiring specialized experimental tests and/or technologies.
Duration: 6-month contract
Location: Cambridge, Massachusetts
Compensation: $45-50 per hour
- Education: Bachelor's Degree or international equivalent required, Life Sciences preferred.
- Must have 6+ years of experience in the pharmaceutical industry and/or a clinical research organization, including 3+ years clinical study/project management.
- Must have experience in early phase clinical studies/Phase II studies or later phase global/international studies or programs.
- Excellent teamwork, organizational, interpersonal, conflict resolution and problem solving skills.
- 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.
- * Requires approximately 5-20 % travel, including overnight and international travel to other Takeda sites, strategic partners, and therapeutic area required travel.
- Must be an out-of-the-box/innovative thinker.
Sthree US is acting as an Employment Business in relation to this vacancy.