Companion Diagnostics , CDx Clinical Project Manager - FSP

Job Purpose:

The CDx Clinical Project Manager is responsible for supporting the Translational Sciences organization, which functions to generate, implement, and execute biomarker strategies for the Client’s drug programs that have progressed to clinical development.  The position collaborates cross-functionally with other areas of the Client as well as with external partners to achieve goals that are critical for drug development.  This role will work closely with the Diagnostic/CDx Development Team, external diagnostic partners, Regulatory Affairs, and Clinical Trial Operations groups to organize and drive deliverables forward to support key milestones of diagnostic development, clinical study initiation and relevant submissions in coordination with key cross-functional groups.  The CDx CPM will be responsible for contract ownership with external diagnostic partners and/or Clinical Research Organizations (CROs), management of key milestones and cross-company coordination of submissions associated with Companion Diagnostics.  This position will interact with multiple internal teams to maintain an overall company perspective.

Key Accountabilities:

Companion Diagnostics (CDx):

• Manages project timelines ensuring they are aligned with functionalactivities across the diagnostic partnerships• Identifies paths for risk mitigation for key milestones such as diagnosticregulatory submissions• Provides portfolio management oversight for study team activities acrossglobal diagnostic submissions, including EU In Vitro Diagnostic Regulation (IVDR)• Participates in internal IVDR process improvement initiatives• Oversees execution of project activities per contract and serves as thecontract owner to manage timely achievement of deliverables, includingrisk mitigation

Collaborative Relationships:

• Navigates the cross-company project team to integrate various functionsas a cohesive effort to drive deliverables for clinical programs with a diagnostic element

• Assists in triaging health authority and ethics committee feedback torelevant teams upon receipt• Facilitates cross-functional communication for the partnership as itpertains to the diagnostic portfolio• Leads cross-functional collaboration that will deliver high-quality outputson time with agreed upon standards

Compliance with Parexel standards:

• Complies with required training curriculum• Completes timesheets accurately as required• Submits expense reports as required• Updates CV as required• Maintains a working knowledge of and complies with Parexel processes,ICH-GCPs and other applicable requirements

Skills:• Strong proficiency with project/program management practices, tools, and methodology• The ability to push back on competing priorities and good conflict resolution skills• Business acumen with capability to plan and oversee budgets for various projects, contracts, and/or programs• Proven track record of good decision-making and exercising sound judgment• The ability to build and develop effective working relationships with key stakeholders and employees at all levels• Demonstrated ability to think critically and solve complex problems with excellent analytical skills• Strong communication and presentation skills with the ability to communicate complex information to a broad audience• Demonstrated understanding of project management concepts, and project management certification a plus• Results oriented• Embraces working in a culture where receiving and providing feedback is valued• Ability and willingness to travel• Proficiency in written and spoken English required• Proficiency in the local language as applicable

Knowledge and Experience:• Minimum of 2 years’ experience in a direct clinical / CDx project management role• Minimum of 6 years of multi-disciplinary experience in biotech/pharmaceutical industry including diagnostic industry or College of American Pathologists/Clinical Laboratory Improvement Amendments (CAP/CLIA) laboratory setting• Experience using Project Management software to manage complex program timelines and resources• Familiarity with the CDx development process• Knowledge of the regulatory submissions associated with CDx and/or medical devices• Experience in global study start-up activities for clinical trials

Education:

• Bachelor’s degree in life sciences or other relevant discipline.  Advanced degree desired• Certificate in Project Management from an accredited University preferred

EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the United States includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.