Clinical Operations

  • location: Cambridge, MA
  • type: Contract
  • salary: $74 - $86.53 per hour

job description

Clinical Operations

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Job Title: Clinical Operations Program Leader - Early Phase Neuroscience & GI

Position Description

  • You will provide operational expertise and strategic input to the development of Clinical Development Plans supporting the overall clinical strategy through to Early Proof Of Concept (EPOC).
  • You will develop and lead the operational strategy on assigned programs in close collaboration with our strategic partners.
  • You will represent Early Clinical Operations on both the Global Program Team (GPT) and the Clinical Sub Team (CST).
  • You will provide sponsor's oversight of our strategic partners, program-level direction and support to ensure the effective execution of the clinical studies.
Position Responsibilities

  • Is accountable to the GPT for the translation of the CDP into an optimal operational plan. Ensures assessment of various scenarios for optimal execution of the CDP.
  • Partner with the Clinical Translational Scientist 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 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 Clinical Program Operations strategy on assigned clinical programs in close collaboration with our strategic partners and with the CST.
  • Perform oversight of our strategic partners to ensure the overall operational execution and delivery of the assigned clinical programs in compliance with quality standards (including ICH GCP, local regulations and company SOPs), on schedule and on budget.
  • Collaborate with cross-functional counterparts to oversee the performance for all activities assigned to our strategic partners, including escalation of issues to governance committees and to senior management when warranted.
  • Is a key point of contact between the strategic partners and the GPT/CST.
  • Is responsible for clinical program budget planning and accountable for external spend related to clinical program execution. Works closely with strategic partners, Global Project 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 strategic partners for the development of study strategy operational plans including enrolment models and risk management strategy.
  • 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 to ensure inspection readiness.
Position Requirements

  • Bachelor's Degree or international equivalent required, Life Sciences preferred.
  • Advanced degree is highly desirable.
  • Expertise in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EUCTD, and ICH GCP. Awareness of local country requirements is also required.
  • Demonstrated excellence in project/program management and matrix leadership
  • Fluent business English (oral and written)
  • 7+ years' experience in pharmaceutical industry and/or clinical research organization, including 4+ years clinical study/project management. Experience must include early phase clinical studies/Phase 2 studies and global/international studies or programs. Experience in more than one therapeutic area is highly desired.
  • Requires approximately 5-20 % travel, including overnight and international travel to other company sites, strategic partners, and therapeutic area required travel.

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance
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Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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