Head of Clinical Operations

Provide high level and complex scientific and clinical guidance to OTC switch studies
Oversee CROs’ study management, Biometrics, Global Drug Safety, Regulatory and Project Management to meet project deliverables and timelines
Primary oversight of CRO conduct for ongoing clinical trials
Provide ongoing clinical monitoring for clinical trials including but not limited to assessment of eligibility criteria, toxicity management, and drug safety surveillance.
Adhere to regulatory requirements of study conduct and industry standards of Good Clinical Practice and SOPs
Develop and implement operational plans and direct resources for new clinical studies from initiation through archival of TMF
Oversight of CRO contracting process (Master Service Agreements, Work Orders, Change Orders)
Oversight of Monitors (appropriately qualified external third party or internal CRA)
Coordinate the collection and assimilation of ongoing data for internal analysis and review.
Coordinate and manages the preparation and/or review of data listings, summary tables, study results and scientific presentations.
Drafting and reviewing parts of FDA submission documents.
Presents scientific information at clinical study investigator meetings
Develop and manage departmental budgets to effectively achieve corporate goals

Rx to OTC switch study research & operations expertise and experience, including experience on an actual use trial (AUT)
A minimum of 10 years’ experience in pharmaceutical or consumer healthcare, with a minimum of 5 years in clinical operations.
Excellent scientific written communication skills, including experience drafting parts of FDA submission documents
Strong familiarity with regulatory strategy and good clinical practices and International Conference on Harmonization Guidelines is preferred
Ability to work highly effectively with multi-disciplinary team
Capable of working with attention to detail in a time sensitive environment
Excellent organizational skills

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