Beschreibung
General information:- latest start date: 01.11.2019 / asap
- duration: 12 months
- workload: 100%
- must have: Training in a basic scientific discipline is preferred, with proven clinical operations experience, preferably in big pharma. Experience in oncology, and / or industry experience managing biomarkers would be great to see.
Job Description:
- Ensures the timely and efficient delivery of all biomarker operational aspects of one or more studies within the Oncology Therapeutic Area through all phases (phase 1b-IV) supported by Pharma Development
- Provides biomarker operational expertise and guidance to one or more cross-functional global Study Management Teams (SMTs)
- Accountable for planning, coordinating, and overseeing all operational activities required to manage the lifecycle of biomarker samples (including companion diagnostic samples) * (collection, processing, analysis, data delivery process and final sample disposition).
- Responsible for collaborating closely with biomarker scientists and Biomarker Operations Program Leaders (BOPLs) to execute biomarker operational strategies, serving as a single point of contact for biomarker operations on multiple SMTs, and with internal and external stakeholders.
- Develops and maintains effective working relationships with SMT members, with particular focus on the operational team, diagnostic partners, external CRO & Central Lab (for outsourced teams), and external biomarker vendors
- Manages the development and oversight of the biomarker analysis timelines, budget, risk and quality plans
- Provides clinical biomarker operations expertise to ensure operational feasibility and delivery
- Delivers the operational elements of the biomarker management plan
- Provides the day-to-day operational management of biomarker vendors to ensure delivery against contracted scope of work
- Identifies areas of best practice and process improvements; may lead or be a representative on functional groups goals, initiatives and work-streams
- Ensures study and biomarker operational adherence to ICH/GCP and SOPs
Qualifications:
- Life sciences degree (Bachelor or Masters) in Scientific, Medical or Healthcare subject area required.
- Further qualification, e.g. PhD and/or project management certification is desirable.
- 3+ years related professional experience in a clinical research setting, clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environment
Skills & Knowledge:
- Extensive clinical development experience with evidence of working in teams running clinical studies
- Clinical or biological laboratory experience with evidence of involvement in the processing and/or analysis of biological samples
- Project management skills and global Vendor Management experience preferred
- Critical reasoning skills including the identification and resolution of complex problems
- Detail oriented with the ability to work independently and manage multiple competing priorities
- Planning, organizational and time management skills
- Professional interpersonal skills, excellent oral/written communication and influencing skills
- Proven leadership skills, ability to successfully achieve results within a multi-cultural and geographically diverse team
- Creates team culture and promotes team spirit.