Biomarker Clinical Operations Lead in PDG (m/f/d)

Biomarker Clinical Operations Lead in PDG (m/f/d) - clinical/diagnostic/pharmaceutical/biotechnology R&D/clinical development/project management/biomarker analysis/vendor Management/English

Project:
For our customer a big pharmaceutical company in Basel we are looking Biomarker Clinical Operations Lead in PDG (m/f/d).

Background:
At Roche/Genentech Pharma Product Development (PD) Global Clinical Operations (PDG), we are determined to transform drug development and realize our Pharma Ambition to deliver 20 transformative medicines addressing diseases with the highest societal burden by 2029. PD's mission is to improve patients' lives around the world through unique medicines that have a meaningful impact. Cross functionally we conduct global clinical trials, analyze results, monitor safety, and work with regulatory authorities to provide truly differentiated medicines to patients. Our primary therapeutic focus areas are Oncology, Hematology, Neurology, Immunology, Ophthalmology, Cardiovascular, Renal, and Metabolism. We attract, develop, and retain the most talented people in the industry, and have Development centers in Basel, Switzerland; South San Francisco, California; Welwyn Garden City, England; Mississauga, Canada; and Shanghai, China, as well as operations in many other countries.

The Biomarker Clinical Operations Lead (Biomarker Operations Project Manager accountable) in PDG at Roche/Genentech is responsible and accountable to provide BIOMARKER OPERATIONAL EXPERTISE by planning, coordinating, and overseeing all operational activities for the life cycle of biomarker and companion diagnostic samples and data, for PDG clinical studies.

The perfect candidate: The ideal candidate is someone with a scientific education, 3+ years of experience with a minimum of 1 year in clinical operations in pharma. We are looking for a strong candidate able to come in and quickly support. This person should have good experience with vendor and project management working in a global Matrix environment and experience with biomarkers in a pharma and clinical setting

Tasks & Responsibilities:
* Provide biomarker/IVD operational expertise to clinical study teams to ensure operational feasibility and quality data delivery
* Be accountable for the development of the BIOMARKER MANAGEMENT PLAN and the execution of deliverables for assigned drug and device studies (eg IVD clinical performance studies) in partnership with the Clinical Study Lead or designee
* Manage all study level biomarker operations activities for both clinical (ie drug) and IVD studies (eg manage vendor/testing sites, ICF/protocol input, eTMF/RACT set-up, sample/data flow, data quality and transfer set-up)
* Partner with internal/external stakeholders in the central lab set up, providing sample collection and processing instructions, shipping conditions and logistics for biomarker samples
* Lead identification, selection and oversight of BIOMARKER VENDORS, including development and oversight of scope of work, budget, ensuring quality delivery and performance
* Actively partner with Data Management to oversee and coordinate biomarker data format and delivery timelines
* COLLABORATE AND PARTNER with cross functional stakeholders (eg study team members, biomarker science, CDx, procurement, testing site monitors, diagnostic partners, central lab) to execute biomarker/IVD operational strategies, serving as a single point of contact for biomarker/IVD operations on multiple study teams
* Provide technical knowledge of aspects related to biomarker analyses (eg sample collection and handling, assay, device and imaging technologies)
* Develop and oversee biomarker analysis TIMELINES, BUDGET, RISK, COMPLIANCE and QUALITY, ensuring adherence to ICH/GCP, SOPs, ISO 20916 and regulatory requirements
* Attend operations team meetings and investigator/monitor meetings, as applicable, to deliver presentations and in-depth trainings to internal and external stakeholders on biomarker and companion diagnostic sample collection, handling and IVD procedures
* Provide responses to biomarker sample/IVD related questions or issues from Health Authorities
* IDENTIFY AREAS OF BEST PRACTICE and process improvements and contribute to/lead initiatives (if requested)
* You will work on business priorities as directed
* Expectation of ongoing and sustained onsite presence in compliance with local requirements

Must Haves:
* Minimum Bachelor/Master in Life Sciences (in Scientific, Medical or Healthcare subject area). Further qualification, eg PhD and/or project management certification is desirable.
* 3+ years of experience in a clinical research setting, clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environment
* Extensive clinical development experience with evidence of working in teams running clinical studies
* Strong experience with vendor and project management
* Possess strong knowledge of drug development process and respective regulations, including ICH and GCP guidelines
* Have a clinical or laboratory experience with evidence of involvement in the processing and/or analysis of biological samples
* Experience working in a global and Matrix environment
* Excellent collaboration, communication, influencing and presentation skills
* Critical reasoning skills including the identification and resolution of complex problems
* Detail oriented with the ability to work independently and manage multiple competing priorities
* Fluency in English with additional language skills as an asset

Reference Nr.: 923988SDA
Role: Biomarker Clinical Operations Lead in PDG (m/f/d)
Industrie: Pharma
Workplace: Basel
Pensum: 100 % (Home Office: Upto 2 days per week)
Start : ASAP (latest start date 01.06.2025)
Duration: unlimited
Deadline: 09/02/2025

If you are interested in this position, please send us your complete dossier via the link in this advertisement.

About us:
ITech Consult is an ISO 9001:2015 certified Swiss company with offices in Germany and Ireland. ITech Consult specialises in the placement of highly qualified candidates for recruitment in the fields of IT, Life Science & Engineering.
We offer staff leasing & payroll services. For our candidates this is free of charge, also for Payroll we do not charge you any additional fees.