Manager, Scientific Operation II - Fast Hire

Job Title: Manager, Scientific Operation II
Job Schedule: Candidate must be local and able to come into the Basking Ridge, NJ office twice a week.
Job Summary: The position of Manager Scientific Operation, Precision Medicine (PrM) will be responsible for managing a broad spectrum of PrM scientific operation activities, including but not limited to contracting (budget forecast, contract execution and invoice inquiry resolution, etc.), project management and coordination of PrM sub-team activities and regulatory submission deliverables, PrM regulatory documentation management, liaison with internal and external partners and provide project management and technically-associated logistic support for clinical bioanalysis and biomarker tasks, identify scientific operation improvement opportunities and drive cross-functional process improvement initiatives.
Responsibilities
Collaborates with Outsourcing, Finance, Purchasing and vendors to execute contracts and amendments, resolve invoice queries, generate budget estimation and support PO tracking activities.
Applies project management disciplines to organize, formulate and execute timelines for PrM projects including regulatory submission activities with high degree of independency. Facilitate and manage interaction and alignment with cross departmental and external stakeholders to accomplish critical PrM project goals.
Coordinate PrM project team/sub-team activities. Manages memberships, facilitates meetings to assemble study deliverables at multiple decision points in the Global Drug Development Process and authors meeting summary across multiple PrM sub teams.
Performs document management support for PrM submission activities - drives review and approval workflow in partnership with Medical Writing and Publishing teams, manages PrM documents on shared drive to support submissions.
Identifies opportunities and recommends strategies for scientific operations process improvement that promote efficient collaboration of PrM with other internal and external collaborating partners
Provides Scientific Operational Support for the Clinical Bioanalysis and Translational Biomarker teams including study management support across multiple programs. Applies project management discipline to establish and implement clinical bioanalysis timelines, oversight of vendor and project deliverables and manages study logistics including sample tracking and reconciliation. Act as the functional point contact for coordinating vendor access requests to DS data and documentation repository systems.
Leads the task of establishing study-specific work procedure for reporting Anti-Drug Antibody data from bioanalytical lab to clinical sites. Coordination and liaise multiple stakeholders to maintain ongoing ADA sample results tracking, which is needed for clinical study subject follow up visits decision making.

Years of Experience
Experience Details
Required/
Preferred
4 or More Years
Working experience in pharma industry
required
and
1 or More Years
Working experience in global drug development organization
preferred
1 or More Years
Working experience in managing contracting activities is strongly desired.
preferred
1 or More Years
Project management experience. Fluent use of Microsoft Project to create Gantt charts is expected.
preferred
1 or More Years
Experience with GxP, TMF and Submission Vault system
preferred
Competencies
Competencies (Optional)
Ability to multi-task across projects and functions
Strong communication skills with track record for driving process improvement initiatives
Effective collaboration in highly matrixed team work environment