ABOUT THE NEST
At bluebird, only two things matter - patients and our people. When you join the nest, you're not just landing a new gig, you become a part of a flock that's soaring to new heights. We’re 1100+ doers, thinkers and collaborators across the globe with a strong sense of our values and our purpose. Our innovation and sustainability are rooted in the diversity of our teams and results are achieved through cooperation and the incorporation of multiple points of view. This is personal and we approach every challenge with radical care. The time is now to rise up and recode the science, the systems, and the status quo.
ABOUT THE FLOCK
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 LentiGlobin to treat, and potentially cure, patients with sickle cell anemia. The successful candidate will be involved in 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 and become a pioneer in the field of clinical gene therapy, and to take on a major leadership role in a rapidly growing organization.
HOW YOU’LL FLY
As Senior Medical Director you will have a key role in drug development at bluebird bio and contribute to protocol development, study design, clinical study execution and supporting Health Authority Interactions. You will be responsible for analyzing and interpreting study data and ensuring that all studies are conducted with the highest level of ethical and safety standards and are in compliance with GCP and all regulatory policies.
- Act as primary medical monitor for one or more trials of gene therapy for hemoglobinopathy, overseeing subject safety and protocol adherence;
- Lead the clinical study protocol development process by translating the strategy and approved concept into executable, efficient clinical protocols and related documents;
- In collaboration with biostatistics, clinical pharmacology, translational research, clinical operations and data management, contributes to the development of the plan to execute on trial design;
- Identify study issues and program issues by reviewing and monitoring emerging clinical data related to safety and efficacy. Develop sound, strategic solutions to issues and collaborate with the clinical team to ensure issue resolution;
- Support the development of program documents, including the clinical sections of various regulatory documents such as INDs, clinical study reports, investigator brochures, annual reports and updates, and clinical sections of regulatory submissions to support product approvals;
- Develop presentations and communicate study data results to colleagues internally and to external audiences including investigators at sponsor meetings or general audiences at scientific conferences;
- Maintain current knowledge of the external environment to ensure scientific innovations are considered and/or incorporated into clinical trial development strategy;
- Work as part of a highly matrixed organization to support the operational effectiveness of study execution;
- Travel, as necessary, nationally and internationally.
WHAT YOU’LL BRING
You’re the bird we’re looking for if you have:
- MD with Board Certification, preferably in Hematology or experience in rare orphan diseases and/or gene therapy;
- 3+ years of relevant clinical research experience; experience in the biopharmaceutical 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
- Knowledge of good clinical practices
- 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
- Critical traits for success include strategic and proactive thinking, strong scientific and analytical skills, decisiveness and the ability to perform as a respected team member and leader;
- 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
All our birds embrace the principles of the bluebird bio culture: b colorful, b cooperative, b yourself.
bluebird bio is deeply committed to fostering an environment where diversity and inclusion are not only valued, but prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways. Diverse viewpoints bring diverse capabilities which strengthen our focus and fuel our growth.
bluebird is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.