PDx Operations Lead
PDx Operations Lead
Job Number: 20-06847
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a PDx Operations Lead for our client in Lawrenceville, NJ.
Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!
- Work closely with the Pharmacodiagnostics (PDx) team to coordinate and track investigational Companion Diagnostic assay development/validation for clinical trial sample analysis, in order to support Client’s large Precision Medicine pipeline.
- Will be responsible for ensuring timely delivery of project goals from various types of technologies, such as genomics, flow cytometry, LC/MS, ligand binding assays, IHC and pathology.
- The PDx Tech Ops role will include end-to-end oversight or project initiated by PDx scientists, from contracting through data delivery, analysis and report documentation.
- Should have proven work experience in one or more of the technologies (genomics, flow cytometry, LC/MS, ligand-binding assays, IHC, pathology).
- Prior experience managing work at third party vendors or central labs to support PDx data generation along with exposure to quality and regulatory requirements (e.g. CLIA, ISO) is desired.
- This is a highly matrixed position and relies on strong organization expertise and robust soft skills.
- This position will require the ability to work remotely/independently.
- Successfully manage and support the relationship with the PDx team and TM stakeholders
- Participate directly on the PDx functional team in a matrix role to ensure close connectivity and awareness of critical activities and priorities for the organization
- Develop operating models and processes as needed to ensure effective engagement with PDx vendors and alignment with broader PDx planning/logistics
- Function as the single point of contact between the PDx scientists and the Client Biorepository for sample management related to PDx development programs, including planning sample bank requirements for PDx programs
- Manage all operations for non-clinical/bridging studies under scientific oversight of the PDx team
- Interact with key scientific and operational leaders in single or multiple therapeutic areas
- Ensure efficient operational coordination across multiple internal functions, including related project management teams, clinical teams, vendor management, outsourcing management, global procurement, biomarker leads, biomarker and sample operations, quality, as needed, to enhance the value of vendors’ capabilities to Client through early engagement with internal teams and partners, cross-organizational discourse and planning transparency
- Coordinate subject matter expert data reviews for biomarker endpoints under the oversight of the PDx team (ensure proper assignment of activities and coordination of timelines to meet clinical database locks)
- Ensure effective management of vendor queries related to PDx partners; identify trends and develop operational improvements to eliminate systemic issues
- Oversee sample quality with biomarker leads and clinical operations (ensure PDx-specific input into sample collection & lab manual to allow for proper sample treatment, and to ensure sample retention for bridging/validation activities where needed)
- Manage and coordinate diagnostic kit forecasts for the clinical portfolio (e.g. PDL1 kit forecasts)
- Maintain internal workflow and project tracking system (TeMPO) for all PDx assay development, validation & sample analysis requests; develop PDx Projects in TeMPO as needed for additional project types to ensure complete capture of PDx Book of Work.
- When required, establish data transfer plans from vendors to development teams or PDx for data analysis or quality control. Establish quality metrics, as required.
- Review statements of work (contracts) with new vendors to ensure operational feasibility and assist in on-boarding vendors
- Participate in quality audits related to samples and coordinate CAPA responses, if needed
- Establishes and maintains operating mechanism to facilitate the cohesive and uniform transparency across many projects and external partners
- Coordinate internal resources and third parties/vendors for the flawless execution of projects and BoW activities
- Establish and maintain relationships with third parties/vendors
- Maintain list of approved vendors/validations/indications/uses
- Function as liaison between PDx team, training vendor, and scoring vendor for IHC/pathology work, as well as other technologies.
- Assist in the definition of project scope and objectives, involving all relevant stakeholders and ensuring technical feasibility
- Ensure that projects are delivered on-time, within scope
- Develop a detailed project plan to monitor and track progress
- Manage changes to the project scope, project schedule, and project costs using appropriate verification techniques
- Measure project performance using appropriate tools and techniques
- Create and maintain comprehensive project documentation
- Perform risk management to minimize project risks; facilitate the transparency of risks and progress for their technology team to key stakeholders and team members
- Maintain documentation in TMF (trial master file)
- Report to PDx Head on established frequency regarding project status, issues, and risks.
- Bachelor’s degree and 4+ years’ experience in clinical drug development/scientific discipline, or Master’s degree and 2+ years’ experience.
- Significant exposure to biomarkers, Pharmacokinetics or immunogenicity operations required, including collections and logistics considerations.
- Understanding of clinical data and management required.
- Firsthand knowledge of laboratory operations highly desired, including validation requirements for CLIA, CAP, clinical trials assays, etc.
- Broad knowledge of genetics/genomics, IHC, flow cytometry, LC/MS, pathology related to assays, platforms and analysis with deeper expertise in at least one technology platform.
- Demonstrated strong project management skills and ability to drive multiple projects of significant complexity/global scope, in a highly virtualized team environment.
- Demonstrated ability to analyze and interpret complex problems/data from a variety of sources, and through effective decision-making and planning, deliver superior business results.
- Experience in leading organizational/cultural change and managing expectations and risks.
- Thorough understanding of organizational structure, operating culture, effective work styles and achieving results in a changing environment.
- General understanding of the pathway to developing a diagnostic assay, from identification to FDA approval.
- Exposure to CLIA/CAP regulations and regulatory guidelines/submissions a plus.
- Ability to influence in the matrix and across organizational/company boundaries.
- Experience and high degree of fluency with MS Office tools (esp. MS Excel and MS Project).
- Ability to quickly learn and leverage in house IT technology solutions for information management.
- Highly effective organizational and time management skills.
- Demonstrates strong communication (written and oral), interpersonal and negotiating skills.
- Fosters teamwork between Client functional areas; creating a team environment based on mutual trust and respect.
- Encourages teams to share knowledge, experiences, best practices, and information on an ongoing basis.
- Embraces a culture of diversity and inclusion to enhance personal and company performance.
If hired, you will enjoy the following Eclaro Benefits:
- 401k Retirement Savings Plan administered by Merrill Lynch
- Commuter Check Pretax Commuter Benefits
- Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
If interested, you may contact:
Jane Bautista | LinkedIn
Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.