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Associate Global Correlative Science Leader, NJ or Cambridge, MA

Novartis Pharmaceuticals Corporation

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Location:
East Hanover, NJ
Posted Date:
7/31/2014
Position Type:
Full time
Job Code:
145436BR
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

Contributes to the late stage development of oncology compounds by supporting the im-plementation of scientifically-driven clinical development plans, including correlative scientific components encompassing clinical biomarkers for all clinical studies and translational research activities to support the global program team. Acts as pathway subject matter expert within the global program team and the clinical development team
1. Accountable for supporting a Global Correlative Science Leader (GCSL) or Sr. (GCSL) and leading an assigned Correlative Science program under the supervision of a GCSL or Sr.GCSL.
2. Assists in timely planning and strategic execution of patient selection, stratification, pharmacodynamic and other clinical biomarker studies for clinical trials by working with internal stakeholders (global line functions) and external partners (Clinical Research Or-ganizations and Academic Labs) for assigned program(s).
3. Leads the Global Biomarker Subteam in a matrix
4. Serves as a member of the International Clinical Team and Clinical Trial Team
5. Responsible for biomarker data review and analysis and for establishing and overseeing external translational preclinical and clinical collaborations.
6. Supports clinical development plan by identifying, implementing and interpreting appropriate preclinical research
7. Serves as subject matter expert in identifying and selecting biomarker vendor labs
8. Liaises with Companion Diagnostic function to facilitate companion diagnostic development as needed including oversight of planning and implementation of diagnostic testing into clinical trials.
9. Co-authors the biomarker portions of key clinical documents including Clinical Development Plan, Correlative Science Development plan, Clinical Study Protocols, In-vestigator Brochures, and Clinical Study Reports (CSRs)
10. Assists in support of regulatory submissions by contributing to 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.
11. Partners with Biosample Clinical Managers (BCM) 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.
12. Actively educates other team members through knowledge sharing. Contributes to the development and implementation of processes supporting patient pre-selection and stratification, pharmacodynamic monitoring and correlative studies
EEO Statement  The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
Minimum requirements  Ph.D. with minimum 5 years experience in correlative science / Oncology / Molecular Biology, in academic setting or industry setting.
OR
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
  • Ability to work on multiple projects and under strict deadlines
  • Excellent oral/written/presentation communica-tion skills
  • May have some contact with external groups in-cluding medical experts.
  • Publications in top-tier journals a plus.

    Requirements

    Ph.D. with minimum 5 years experience in correlative science / Oncology / Molecular Biology, in academic setting or industry setting.
    OR
    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
  • Ability to work on multiple projects and under strict deadlines
  • Excellent oral/written/presentation communica-tion skills
  • May have some contact with external groups in-cluding medical experts.
  • Publications in top-tier journals a plus.
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