Sr. Director, Clinical Development Operations

Location
Cambridge, MA, United States
Posted
Aug 24, 2018
Ref
871903
Hotbed
Genetown
Required Education
Bachelors Degree
Position Type
Full time
bluebird bio's growing Clinical Development Operations team is setting the standard for trial design, conduct, and analysis in gene therapy across multiple therapeutic areas. Join our collaborative, creative and passionate team as we help bring the promise of gene therapy to patients with severe genetic diseases and cancer. This is not your typical development operations role - come fly with us!

As Senior Director of Clinical Development Operations you will be responsible for helping to set strategy for organizational growth, development operations and integration with other functions. You will be managing senior clinical program leads across our four development programs. In this leadership role you will be tasked with standardizing the approach to global clinical trial operations across our therapeutic areas so that we can consistently produce quality and timely deliverables. You will participate in departmental and cross functional risk assessment, technology development and process improvement initiatives. Core responsibilities will be oversight of our ongoing development programs. You will be working with senior CDO leaders to establish a strategy for organizational build, process improvement initiatives and operational efficiency as the portfolio grows. You will be responsible for building infrastructure within trial management and with our cross-functional partners. You are someone who challenges himself/herself on meeting clinical milestones with seamless execution and within established timelines, budgets, and quality standards. You know what it takes to be successful in managing your direct reports, ito ensure successful execution of our clinical programs . You will be responsible for hiring, training, managing, coaching, mentoring, and performance management (including compliance) in a matrix environment. This role is expected to require 10-20% travel, including international travel.

About You:
  • Bachelor's Degree or international equivalent required, Life Sciences preferred. Advanced degree highly desirable.
  • At least 18 years clinical study/program management experience in the pharmaceutical/biotech industry with increasing responsibility, including at least 12 years of line management experience.
  • Proven track record of leadership and operational excellence required.
  • Experience in rare disease and oncology studies preferred
  • Expert knowledge of global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, local country requirements and ICH GCP.
  • Registration (BLA/NDA/MAA) submission experience
  • Have contributed to communications at scientific congresses and publications
  • Experience in successful change management including developing the strategy and implementing important, organization wide changes.
  • Deep understanding of managing external relationships, specifically with Investigators, advisors, other study personnel, clients and vendors.
  • Attend seminars, Investigator meetings, project team meetings, educational conferences/training sessions, etc. Expected to present at industry meetings as an expert in global clinical trial operations.
  • Ability to work effectively in a collaborative team environment where results are achieved through influence, cooperation, and the incorporation of multiple points of view
  • Independently motivated, detail oriented and good problem solving ability
  • Excellent organizational skills, with an ability to embrace change and multi-task in an extremely fast-paced environment
  • Excellent communications skills and ability to influence across multiple functions
  • Be ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself