Translational Medicine Operations Lead with Clinical Biomarker Experie

Company: Alpha Consulting Corp.
Location: San Diego
Posted on: February 24, 2021

Job Description:

TRANSLATIONAL MEDICINE OPERATIONS LEAD WITH CLINICAL BIOMARKER EXPERIENCE SAN DIEGO, CA Project Description: Reporting to Senior Scientific Director, Translational Medicine, the TM operations lead will be part of the late-stage group based in San Diego, CA. The individual will support operational aspects of TM and clinical biomarker activities to support drug development programs in multiple disease areas including immunology and neurology. This individual will have the opportunity to assume primary translational ops responsibilities, such as setting up cross-functional team meetings, generating and tracking translational timelines and budget, interacting with CROs and KOLs to support contracting management, and sample analysis and data delivery of biomarkers in clinical studies. The successful candidate will have prior project management experience in biotech/pharma organizations interacting with project teams, clinical research physicians, statisticians, computational biologists, contract research organizations and translational scientists to deliver science that supports the development of medicines to patients in need.

• Responsible for setting up team meetings, taking and dissemination of meeting minutes
• Manages timelines for ongoing late-stage translational activities including biomarker clinical trial activities and KOL collaborations
• Supports management of team budgets and shepherding contracts through internal processes
• Implements translational operations activities through direct interaction with clinical research physicians, statisticians, clinical operations, computational biologists, contract research organizations, academic experts, and internal translational scientists as needed
• Aids in biomarker data delivery for clinical studies through working with relevant functions and CROs; responsible for aiding in creation of SOWs and interfacing with CRO for execution of services
• Supports regulatory submissions and regulatory interactions as needed Required Skills:
  • Program management software
  • Understanding of drug discovery and development, especially late stage development
  • Experience in activities required for and related to clinical trial initiation, maintenance and completion
  • Experience in interacting with CROs and KOLs to manage projects and timelines
  • Proven scientific/leadership expertise (working in teams, mentoring people, managing projects)
  • Accountable for timelines and deliverables
  • Prioritizes risks and implements contingency plans
  • Communicates regularly; prepares and delivers presentations within the department, to governance and senior leadership bodies, and externally as requested
  • Recognizes cross-functional issues and communicates within the larger organization.
  • Provides expert guidance to multi-disciplinary teams and senior management.
  • Has a track record of delivering results, driving continuous improvements, and building effective cross-functional networks.
  • Ability to prioritize and manage time efficiently
  • Strong verbal and written communication skills
  • Accurate and detailed record keeping
  • Excellent organizational skills Education:
    • M.S./Ph.D., and 2+ years of biotechnology or pharmaceutical industry project management experience.
    • PMP preferred.
    • Candidate must be a rigorous, detail-oriented scientist, with excellent record keeping and organizational skills.
    • Must be a highly flexible, results oriented, independent self-starter who enjoys working in a fast-paced dynamic environment.
      
      This 12+ month position starts ASAP. Please E-MAIL your resume (attachment to email) with rate and availability to Bridget: ALPHA'S REQUIREMENT #21-00573 MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE #ZR#LI-BB1 - provided by Dice

Keywords: Alpha Consulting Corp., San Diego , Translational Medicine Operations Lead with Clinical Biomarker Experie, Healthcare , San Diego, California