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Global Correlative Science Leader

Eingestellt von Harvey Nash IT Recruitment Switzerland

Gesuchte Skills: Support, Design

Projektbeschreibung

For a project in Basel we are looking for self-starters who are interested to work in an innovative work environment.

Administrative Global Correlative Science Leader

Responsibilities:

- Ensures timely execution of patient selection, stratification, pharmacodynamic and correlative studies for clinical trials by working with internal stakeholders (global line functions) and external partners (clinical research organizations and Academic Labs) for assigned program(s) with limited oversight.
- Directly accountable for Correlative Science programs supporting up to two Global Project Teams (GPT)
- Contributes input to the clinical team for assay development, molecular epidemiology, and other research-related activities with other internal stakeholders.
- Liaise with MDx to facilitate companion diagnostic development as needed and serve as a member of the Biomarker/Diagnostics sub-team where implemented. In collaboration with Molecular Diagnostics (MDx) and Translational Medicine (OTM), identify and validate external laboratories involved in CTAs for clinical trials and companion diagnostic development.
- Authors the biomarker portions of key clinical documents including Clinical Development Plan, Clinical Study Protocols, Investigator Brochures, and Clinical Study Reports (CSRs)
- Supports regulatory submissions by acting as subject matter expert within the team. Contributes scientific and technical sections of key regulatory documents including INDs, FDA briefing books, and submission documents. Coordinates data requirements with reference labs to support submission
- Direct contact with external groups including medical experts as well as health authorities
- Partners with Biomarker Clinical Managers (BCMs) and other internal stakeholders to ensure all aspects of data collection are executed with high quality, including correlative science analysis plan, data formatting and transfer specifications, eCRF page design, and monitoring plans for correlative study samples
- Actively educates other team members through knowledge sharing. Contributes to the development and implementation of processes supporting patient pre-selection and stratification, pharmacodynamics monitoring and correlative studies
- Serves as a technology and indication expert in support of all programs, may assist with managing internal stakeholder interactions on behalf of function. May assist or lead functional initiatives
- Act as core member of the International Clinical Team (ICT)

Required skills are:

- Ph.D. with minimum 7 years experience in Correlative Sciences. preferably in Oncology biomarkers, of which a minimum of 3 years must be in Pharmaceutical industry
- MD or MDPhD with a minimum of 2 years experience in development & implementation of patient selection and other correlative strategies for clinical programs and/or oncology clinical trial experience. Residency in a general medical field with additional subspecialty training, preferably in Oncology, Molecular Pathology, or Lab Medicine.
- Ability to work in a team environment
- Ability to work within Matrix organization
- Strong interpersonal and influencing skills
- Fluent in English
- Strong negotiation skills
- Ability to work on multiple projects and under strict deadlines
- Excellent oral/written/presentation communication skills
- Ability to represent company externally to outside agencies or companies Publications in top-tier journals

Are you interested in this position? We are looking forward to receive your application

Projektdetails

  • Einsatzort:

    Basel, Schweiz

  • Projektbeginn:

    asap

  • Projektdauer:

    6 months

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Harvey Nash IT Recruitment Switzerland

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