Clinical Biomarker Operations Manager

Employer
AbbVie
Location
Lake County, IL, US
Posted
Nov 12, 2018
Ref
1808091
Required Education
Doctorate/PHD/MD
Position Type
Full time
The Translational Oncology group at Abbvie uses advanced methods to discover biomarkers and implement translational medicine strategies to progress AbbVie's innovative Oncology pipeline. We are currently seeking highly motivated individuals to join our team to support the development and implementation of Translational medicine strategies, for AbbVie sponsored clinical trials. As a member of both discovery and clinical development project teams he/she will have the opportunity to work in a highly collaborative environment to support projects across all phases of clinical development.

Key Responsibilities Include:
  • Author the translational research sections in key clinical documents such as protocols, informed consents, clinical study lab manuals and clinical study reports.
  • Manage external CRO efforts in support of clinical trials, including supporting sample management, data management, budget management and report generation.
  • Serve as primary point of contact for, and triage, clinical study inquiries from site staff, CROs and site monitors regarding the study protocol, modifications to informed consent, and patient-specific questions.
  • Serve as primary point of contact for queries related to ICFs and IRBs.
  • Support local Clinical Team with the creation and handling of essential documents, including contracts Investigator Site Files, and others.
  • Use multiple technologies to maintain open and frequent communication with internal and external customers, including site study personnel. Maintain a positive working relationship with internal/external customers. May train study site personnel.
  • Partner with clinical and discovery groups to execute high quality biomarker strategies in the clinic.
  • Oversee implementation of clinical trial assays at reference labs and centralized testing vendors
  • May interface with and build collaborative relationships with: Local personnel including Medical Dept. and Clinical Operations, external service providers, study personnel (e.g., investigators, study coordinators, etc.), peers within the organization, and vendors, as well as Regulatory, Finance and Legal Functions, administrative staff and other relevant functional areas.


Level and compensation will be commensurate with experience.

Basic:

  • PhD with 0+ years of related work experience
  • Master's Degree with 8+ years of related work experience
  • Bachelor's Degree with 10+ years of related work experience


Preferred Qualifications:

  • Must have strong understanding of clinical trial protocols and regulatory standards for biomarker research.
  • Must have strong scientific background in cancer biology, biomarkers and drug development, and clinical trial methodology, as well as experience interacting with clinical trial teams. Knowledge of LIMS systems a plus.
  • Understanding of translational sciences employing pharmacodynamic, predictive and exploratory biomarkers and Companion Diagnostic development is preferred.
  • Proven strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with multiple high priority competing projects and deadlines.
  • Excellent communication and interpersonal skills, including situations of conflict resolution, problem solving, crisis management, and change management. Proactive and positive team player.
  • Must effectively work in a cross-functional team environment, interacting with various levels within the organization as well as vendors/academic sites/KOLs.
  • Possesses strong oral and written communication skills; proven ability to successfully negotiate with and influence stakeholders with tact and diplomacy.
  • Written and verbal fluency in English. Proficient knowledge of all standard IT office tools.
  • Proven ability to communicate effectively within a multi-cultural/global team environment.
  • Exhibits high level of flexibility and leadership when facing changes in the work environment.


Key Leadership Competencies:

  • Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance.
  • Learns fast, grasps the "essence" and can change course quickly where indicated.
  • Raises the bar and is never satisfied with the status quo.
  • Creates a learning environment, open to suggestions and experimentation for improvement.
  • Embraces the ideas of others, nurtures innovation and manages innovation to reality.
  • Possesses strong interpersonal skills/emotional intelligence.
  • Adheres to applicable country regulations, legal requirements, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs).
  • Functions as an internal expert in oncology biomarkers and precision medicine and actively educates other cross-functional team members through knowledge sharing.


Equal Opportunity Employer Minorities/Women/Veterans/Disabled