Pharmacyclics, LLC

Translational Operation Manager

Location
Sunnyvale, CA, United States
Posted
Oct 18, 2019
Ref
2871
Hotbed
Biotech Bay
Required Education
Masters Degree/MBA
Position Type
Full time
Pharmacyclics is committed to the development and commercialization of novel therapies intended to improve the quality and duration of life and to resolve serious unmet medical needs for cancer patients. Pharmacyclics is a wholly-owned subsidiary of AbbVie (NYSE:ABBV), a global, research-based biopharmaceutical company. Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products and a pipeline containing multiple promising new molecules that are being studied in more than 200 clinical trials for over 20 different types of cancer.

More than 1,200 Pharmacyclics and AbbVie research scientists, clinicians, marketing, operations and corporate professionals work in the San Francisco Bay Area. They combine their expertise in immuno-oncology, stem cells, and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments. Together, we are striving to outsmart cancer.

To learn more about us, please visit us at http://www.pharmacyclics.com/

General Position Summary/Purpose:

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 Biomarker Program Management team to support the implementation of Translational Medicine strategies. As a member of 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:

  • Provide hands-on support for operationalizing biomarker research in clinical trials, including sample and data management, and CRO management.
  • Author the Translational sections in key clinical documents including Protocols, Informed Consent Forms, Contracts, and Clinical Study Reports.
  • Use multiple technologies to maintain open and frequent communication with various AbbVie functions such as Site Management & Monitoring and Clinical Operations. Maintain a positive working relationship with internal/external customers. May assist CRA in training sites on sample collection/handling.
  • Manage budget and projections for biomarker section of clinical trials. Review vendor documents such as contracts, Lab Spec review and invoices.
  • Adhere to applicable country regulations, legal requirements, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs).


Level and compensation will be commensurate with experience .

Basic Qualifications:

  • Master's Degree in a scientific discipline with 5+ years of related industry and/or academic work experience.
  • Bachelor's Degree in a scientific discipline with 7+ years of related industry and/or academic work experience.

Preferred Qualifications:

  • Proficient in the conduct of clinical trials and associated activities and responsibilities, as well as experience interacting with clinical trial teams; strong background in oncology a plus.
  • Previous experience with Clinical Biomarker Operations.
  • 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 problem solving, crisis management, change management, and conflict resolution. Proactive and positive team player.
  • Able to 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.
  • Knowledge of FDA and/or EMA Regulations (or relevant local regulations), ICH Guidelines, and GCP governing the conduct of clinical studies.
  • Proficient knowledge of all standard IT office tools; knowledge of LIMS systems a plus.
  • Understanding of Translational Sciences and Companion Diagnostic development is a plus.
  • Project Management experience a plus.


Key Leadership Competencies:

  • Ability to operate independently and learn quickly.
  • Possesses strong interpersonal skills/emotional intelligence.
  • Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance.
  • Raises the bar and is never satisfied with the status quo.
  • Embraces the ideas of others and nurtures innovation.


Equal Opportunity Employer Minorities/Women/Veterans/Disabled

Equal Opportunity Employer Minorities/Women/Veterans/Disabled