Opportunity for MD with industry experience at fast growing Gene Therapy company
Join bluebird bio’s experienced and dedicated team to lead the development of transformative gene therapies for life threatening diseases. We are seeking a talented, independent, and motivated clinician to help design, implement and communicate the global clinical development plan for our Lenti-DTM product candidate which has the potential to stabilize or prevent progression of cerebral adrenoleukodystrophy (CALD), a fatal and rare genetic disorder that affects the nervous system of boys and men with one treatment. The successful candidate will also be involved in advising pre-clinical development and ultimate clinical introduction of future gene therapy products targeting other rare, orphan indications. The candidate will serve as the internal and external clinical leader for CALD and future rare, orphan indications, including interactions with key academic advisors, principal investigators, caregivers, patient groups, regulatory authorities, bluebird’s senior management and Board of Directors. This individual will have demonstrated a track record of success in his/her field, the capacity to lead with minimal supervision, plan strategically, achieve goals on time, and communicate effectively. This position also offers the opportunity to apply bluebird bio’s gene therapy platform to other life-threatening diseases (including other metabolic and neurologic diseases) and become a pioneer in the field of clinical gene therapy, and to take on a major leadership role in a rapidly growing organization.
About the role:
- Develop the clinical strategy and integrated development plan for our cerebral adrenoleukodystophy program and future programs in rare, orphan diseases, 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 Monitor 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;
- 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
- MD with Board Certification in Neurology, Genetics or comparable training/ industry experience, and recognized expert within his/her field
- 1-5+ years of relevant clinical research experience with at least some in industry. Experience in the biopharmaceutical industry preferred; substantial experience working on industry-sponsored trials will be considered.
- 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
- 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
- Be ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself
bluebird bio will only accept job applications from candidates who are properly documented with authorization to work in the United States.
Note to Employment Agencies: Please do not forward any agency resumes. bluebird bio is not responsible for any fees related to resumes that are unsolicited.