Associate Director, Clinical Development Operations - Sickle Cell Disease

Location
Cambridge, MA, United States
Posted
Nov 29, 2018
Ref
1402976
Hotbed
Genetown
Required Education
Bachelors Degree
Position Type
Full time
Associate Director, Clinical Development Operations - Sickle Cell Disease

Clinical-stage, fast-growing gene therapy company

Join bluebird bio's enthusiastic and collaborative team by contributing to the overall success of our novel gene therapy approach. Reporting to a Director of Clinical Development Operations in the Sickle Cell Disease (SCD) program, you will be responsible for all aspects of global Phase 3 program for a novel gene therapy-based approach for our exciting and growing sickle cell disease program. Responsibilities include trial planning and execution, timelines, budget, and vendor management. You will also be responsible for the preparation of study related materials, relationship management between clinical sites and vendors, and identification of project risks and contingency planning. You will manage trials to the highest quality to ensure inspection readiness along with timely and robust data collection. The ideal candidate must be comfortable working independently, managing interactions with and between clinical monitors, data management, biostatistics, medical writing, safety, regulatory affairs, and pharmaceutical science and QA team members, both internally and externally. Experience working on global pivotal clinical studies in fast-paced and data driven environment is a plus.

About the role:

* Integral senior member of SCD Clinical Operations team working on pivotal, global clinical studies; experienced to manage day-to-day operations of trials with little supervision

* Lead cross-functional internal/external study management meetings, working closely with your Clinical team members

* Manage to timelines and within budget (MS-Project experience a plus)

* Provide oversight and accountability of study vendors in a fully outsourced model

* Develop and ensure compliance with critical study documents including project plans, monitoring plans, study operations manuals, model informed consent form, IP traceability documents, etc.

* Execute on data deliverables (e.g., IB, DSUR, scientific conferences) in support of cross-functional activities and deliverables

* Train team members and site staff, including vendors, as needed

* Perform clinical site activities, such as on-site monitoring, co-monitoring, training, and motivational visits, as needed

* Review and approve corrective action plans at individual sites and across study, active participant in internal/external study related audits

* Active engagement of Key Opinion Leaders (KOLs) and Study Investigators and staff, frequent communication with Medical Monitor

* Manage teams to meet goals across time zones and regions

* Work independently, escalate issues and reach out for support when needed

* Communicate trial status, issues, and mitigations to relevant cross-functional stakeholders. Engage the input of line functions as appropriate.

* Provide oversight of trials to ensure that safety concerns and/or adverse events are identified and appropriate responses to such concerns are developed and executed

* Actively contribute in the Clinical Development Operations department to the implementation of best practices and standards for trial management, including sharing lessons learned as a senior member of the team.

About you:

* BS/BA/RN Degree in science or a health-related field is preferred with a strong emphasis on science

* Minimum 10 years relevant industry clinical development experience as a Sponsor, with at least 5 years of managing multi-disciplinary project teams

* Line management and career development experience of Clinical Trial Managers or more junior staff

* Experience and understanding of global clinical trial operations, hematology and/or transplant experience welcome

* Experience with all aspects of trial and global site startup and vendor management

* Familiarity with clinical data review and data management processes, including Data Monitoring Committees and conference abstracts/publication preparation

* Forward thinking, data driven, global thinker, excellent organizational skills

* Understanding of thinking beyond clinical development into commercialization; inspection readiness and previous filing experience a plus

* Must be able to travel up to 20%, domestically and internationally

* Clear and succinct verbal and written communication skills. A writing sample may be requested

* Ability to deal with competing priorities, strong reasoning, detail oriented and creative problem-solving ability is essential

* Ability to lead teams with aggressive timelines and to multi-task in a fast-paced environment

* Excellent knowledge of GCP, ICH and FDA regulations

* Independently motivated to learn and lead project teams

* "Do-what-it-takes" approach to problem-solving and prospective thinking

* Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view

* Be ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself.