Friday, 20 December 2019

Project manager – biotech clinical biomarkers

Job Title: Project Manager – Biotech Clinical Biomarkers (JP6731)Location: Thousand Oaks, CA or South San Francisco, CA.

3 days onsite & days remote.Employment Type: ContractBusiness Unit: Clinical Biomarkers OncologyDuration: 12 months with likely extensions ​3Key Consulting is hiring a Project Manager for a contract engagement with our client, a leading international biopharmaceutical company. Job Summary:Position can be flexible, must be able to come on-campus 3 days a week, but can be remote the rest of the week once fully trained and running.The Clinical Biomarkers and Diagnostics department is seeking an enthusiastic and result-oriented Project Manager to manage projects and alliances with key in vitro diagnostic (IVD) partners that are critical to transitioning biomarker tests from exploratory through clinical trial phases to prepare commercialization of in-vitro-diagnostics tests.The Project Manager will work closely with cross-functional leads such as diagnostics technical leads, regulatory leads and clinical operations leads, and will be responsible for managing the partnership lifecycle, including the formation of governance structures, maintaining and growing strategic alignment during the diagnostics research and development phases.This is an excellent opportunity for a driven, experienced, and exceptionally talented individual to join a dynamic organization passionately committed to support company’s pipeline.Ideal Candidate:Will have had extensive Project Management with Clinical Biomarkers and Diagnostics.Additional skills:Introduction and alignment with leads in the Clinical Biomarkers and Diagnostics Department and other key stakeholders in Research, Preclinical, Clinical, Regulatory, and Business Development Introduction to in vitro diagnostic partners (external) for selected projects Drive in vitro diagnostic project, aligning internal stakeholders and managing the relationship with the external partners Top Must have Skill Sets:Industry experience in pharmaceutical and/or diagnostic developmentStrong Project Management experience requiredKnowledge of the diagnostics development process, cGMP manufacturing, knowledge of US regulatory submission process (PMAs and 510(k)), or regulatory submission processes outside of the USDay-To-Day Responsibilities:Lead project team meetings with internal and external stakeholdersFacilitate identification of effective solutions for a range of issues including but not limited to technical, operational, budgetary, and regulatory issuesEscalate internal or external issues that cause a missed milestone/deliverable or could damage partnership healthEmployee Value Proposition:This is an excellent opportunity for a driven, experienced, and exceptionally talented individual to gain visibility across the entire portfolio and join a dynamic organization passionately committed to support scientific advancement. Red Flags:Scientists without true project management experienceNo industry experienceInterview Process: Phone screens with manager and then onsite interview with panel We invite qualified candidates to send your resume to resumes@3keyconsulting.com.

If you decide that you’re not interested in pursuing this position, please feel free to look at other positions on our website www.3keyconsulting.com.

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