Vice President, Oncology Clinical Research

Location
Cambridge, MA, United States
Posted
Aug 24, 2018
Ref
967027
Hotbed
Genetown
Required Education
Doctorate/PHD/MD
Position Type
Full time
Join bluebird bio's experienced and dedicated team to lead the development of transformative gene therapies for life threatening diseases. We are seeking an industry-experienced, talented, independent, and motivated clinician to lead Oncology Clinical Research at bluebird bio and report into the CMO. This pivotal role will provide oncology technical expertise, extensive drug development experience, and executive leadership skills to support, advance and expand bluebird's CART and TCR pipeline. The candidate will work closely with bluebird Research in the selection and advancement of research candidates, and collaborate with Business Development to evaluate potential external oncology opportunities for bluebird bio. You will also design, implement and communicate the global clinical development plans for emerging immune-oncology programs to treat patients with advanced, refractory tumors. In this role, you will be responsible for managing, mentoring and growing the Oncology Clinical Research team, and will serve as an internal and external clinical leader, including interactions with key academic advisors, principal investigators, caregivers, patient groups, regulatory authorities, investors, bluebird's senior management and Board of Directors. This position offers the opportunity to become a pioneer in the field of clinical gene therapy, accelerate the revolution in cellular immunotherapy, and to take on a major leadership role in a rapidly growing organization.

About the role:
  • Partner with the business development team to evaluate novel targets and platforms in the immuno-oncology space;
  • Develop the clinical strategy and integrated development plan for our oncology portfolio, and work cross-functionally to implement, manage, interpret and communicate the results of clinical trials;
  • Be responsible for the clinical content of all clinical and regulatory documents, including protocols, INDs, CTAs, investigator brochures, CRF's, annual IND reports, CSR's, ISS's, ISE's, and clinical expert reports;
  • Lead and supervise clinical trials/registries, collaborating closely with the Clinical Operations team, and will be accountable for all deliverables of clinical trials under his/her direct responsibility;
  • Serve as medical lead and the Sponsor's medical representative to multiple vendors and collaborators; CROs, PIs, core laboratories and other organizations involved in the implementation of clinical trials;
  • Responsible for analysis of clinical data, including safety monitoring in collaboration with PV;
  • Develop and maintain relationships and serve as the main medical liaison with key opinion leaders and PIs;
  • Manage, mentor and build the Oncology Clinical Research team to meet the needs of the organization;
  • Organize and present at relevant clinical advisory boards, DMC's and medical/scientific meetings;
  • Support R&D management and the commercial team with input on clinical development issues related to our commercial plan, and support the business development process by providing medical expertise for in- or out-licensing, partnering and acquisition activities;
  • Help ensure Clinical Study Team compliance with FDA, EMEA, ICH and GCP guidelines and internal SOPs;
  • Travel, as needed, nationally and internationally

About you:
  • MD with Board Certification in Oncology or comparable training, and recognized expert within his/her field
  • 5+ years of relevant clinical research experience in industry
  • Thorough understanding of Phase I-III drug development with proven ability to plan and conduct clinical trials, deliver high quality results within established timelines, interpret, analyze and communicate clinical/scientific data, and generate clinical/scientific documents
  • A demonstrated track record of success in your field, the capacity to lead with minimal supervision, plan strategically, achieve goals on time, and communicate effectively
  • Excellent written and verbal communication skills to meet the needs of varied audiences
  • Strong interpersonal skills commensurate with the need to work closely with partners, investigators, contractors, consultants, and team members across functions
  • Knowledge of FDA/EMA requirements, good clinical practices and pharmaceutical clinical development
  • Excellent analytical, problem-solving and strategic planning skills
  • Well organized with strong management, leadership, mentoring and motivational skills
  • Ability to work independently and thrive in a fast-paced environment
  • Attention to detail, demand for high-quality work, and sense of passion and urgency to achieve goals and improve the lives of patients
  • b ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself