Passage Bio Overview:
Passage Bio is an exciting, fast-paced, rapidly growing gene therapy company headquartered in Philadelphia, PA. Our portfolio of rare monogenic CNS gene therapies is the result of an exclusive collaboration with the renowned Gene Therapy Program (GTP) at the University of Pennsylvania (Penn) that provided Passage Bio with 17 gene therapy candidates developed in the lab of gene therapy pioneer Dr. James Wilson. Passage Bio is on a mission to provide life-transforming gene therapies for patients with rare monogenic CNS diseases that replace their suffering with boundless possibility, all while building lasting relationships with the communities we serve.
Job Overview:
The Biomarker Operations position requires an organized, self-motivated individual with the ability to perform biomarker operational tasks, assess and manage central laboratory and specialty vendors for complex clinical trials, manage vendor contracts and budgets, proactively support risk identification and mitigation strategies, and work cross-functionally to help establish and ensure overall strategy and best practices are followed. This individual will work closely with Biomarker Operations leadership to implement and operationalize the Biomarker Operations goals within Passage Bio's clinical trials. The position requires experience in coordinating multiple projects to support Biomarker Operations.
Responsibilities:
Support of Biomarker Operations
Supports clinical study teams for all technical and operational sample-related matters for assigned projects by liaising with internal stakeholders and external vendors.
Manages collection, shipping and release of clinical trial samples designated for biomarkers and exploratory research and assists with data transfer as needed.
Provides support to the Biomarkers Operations team and clinical sites by helping to ensure oversight and best practices are followed for controlling pre-analytical variables including collection, shipping and storage of biospecimen acquired in the course of clinical trials.
Provides oversight of clinical sample logistics vendors (i.e., white glove shipping services) as necessary.
Provides input on biomarker sections in clinical trial-related (such as protocols and consents) and other supporting documents.
Reviews study documentation to ensure external laboratory processes are considered to minimize gaps and misalignment between study team needs and external laboratory processes.
Provides study level updates to clinical study teams and biomarker teams including sample collection, assay status and analysis updates.
Supports presentations and trainings of sites and monitors as needed.
External Vendor Management
Builds strong partnerships with Central and Specialty labs and serves as a point of contact for routine communications with vendors for supplies issues, assay development, validation and sample analysis related activities, including sample and data reconciliation.
Prepares RFPs; reviews bids, Clinical Lab Specs and other documents from the vendors.
Assists forecasting biomarker study costs, establishing contracts, reviewing invoices, monthly accruals, and phasing to support finance.
Work with the Clinical Operations team to ensure compliance with ICF permissions and provide guidance and training to clinical sites, collaborators and vendors.
Participates in vendor assessment and oversight activities and supports audits as required.
Requirements:
BS, MS or PhD in science
Minimum 8 years of pharmaceutical/laboratory experience in a fast-paced environment
Experience in clinical or biological laboratory processing and analyzing biological samples highly desired.
Working knowledge of the clinical drug development process, preferably in gene therapy and a pediatric population and other rare disease populations.
Experience with managing multiply vendors, including contract and budget management.
Strong interpersonal skills and ability to work with many different groups/teams proactively and collaboratively.
Excellent written, verbal communication and project management skills.
Knowledge of ICH, GCP, GLP, CAP and CLIA regulations, data management, regulatory and legal issues/processes as they relate to biomarker/safety clinical samples, global experience required.
Detail oriented with the ability to manage multiple competing priorities.
Passage Bio is an Equal Opportunity Employer - Minorities/Women/Protected Veterans/Disabled