Manager, Clinical Sciences Group Companion Diagnostics (CDx)
Posted on Dec 13, 2018 by Agilent
- Responsible for overall people & project management of clinical trials activities across the Agilent's Clinical Sciences Group, specifically the CDx group, not excluding the Pathology and Genomics groups:
- Manages, mentors, and trains people in Clinical sciences group.
- Manages & tracks Clinical Sciences study tasks across projects, such as strategic planning, protocol development & design, data surveillance, and clinical portions of regulatory submissions, to ensure all projects have appropriate resources, keep to time and budget, and to solve any urgent issues.
- May develop and manage budgets for clinical sciences team.
- Develops contingency plans for clinical studies and acts as a cross functional liaison to ensure study plans align with business strategies.
- Communicates & coordinates with other departments such as regulatory, R&D, and project management to ensure logistical requirements of the studies to support FDA and other Agencies submissions and approvals are met.
- Ensures quality & consistency of core Clinical Sciences deliverables by providing direction and guidance to the CAS team.
- Evaluates CAS processes and procedures, and implements new and necessary improvements.
- Provides clinical/medical scientific expertise to companion diagnostics partner programs & internal partners & establishes external network of KOLs when needed.
- Participates when required in business development processes to use Agilent technology to potentially address unmet medical needs and develop new products.
- Represents the CAS group in meetings with strategic pharma partners and future partnership negotiations and collaborations.
- Liaise with relevant health care professionals and organizations to explore unmet medical needs and potential product opportunities.
- Ensures compliance with good clinical practices and regulatory guidelines. Prepares, revises and maintains procedures for the conduct of studies.