On January 11, 2021, we announced our intent to separate our severe genetic disease and oncology businesses into differentiated and independent publicly traded companies. We will retain focus on severe genetic disease (SGD) and will launch our oncology business (“Oncology Newco”) as a new entity, with the completed transition expected by the end of 2021.

 

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.

Apply for this Job

* Required

  
  


U.S. Equal Opportunity Employment Information (Completion is voluntary)

Individuals seeking employment at bluebird bio are considered without regards to race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation. You are being given the opportunity to provide the following information in order to help us comply with federal and state Equal Employment Opportunity/Affirmative Action record keeping, reporting, and other legal requirements.

Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.


Form CC-305

OMB Control Number 1250-0005

Expires 05/31/2023

Voluntary Self-Identification of Disability

Why are you being asked to complete this form?

We are a federal contractor or subcontractor required by law to provide equal employment opportunity to qualified people with disabilities. We are also required to measure our progress toward having at least 7% of our workforce be individuals with disabilities. To do this, we must ask applicants and employees if they have a disability or have ever had a disability. Because a person may become disabled at any time, we ask all of our employees to update their information at least every five years.

Identifying yourself as an individual with a disability is voluntary, and we hope that you will choose to do so. Your answer will be maintained confidentially and not be seen by selecting officials or anyone else involved in making personnel decisions. Completing the form will not negatively impact you in any way, regardless of whether you have self-identified in the past. For more information about this form or the equal employment obligations of federal contractors under Section 503 of the Rehabilitation Act, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

You are considered to have a disability if you have a physical or mental impairment or medical condition that substantially limits a major life activity, or if you have a history or record of such an impairment or medical condition.

Disabilities include, but are not limited to:

  • Autism
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, or HIV/AIDS
  • Blind or low vision
  • Cancer
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or hard of hearing
  • Depression or anxiety
  • Diabetes
  • Epilepsy
  • Gastrointestinal disorders, for example, Crohn's Disease, or irritable bowel syndrome
  • Intellectual disability
  • Missing limbs or partially missing limbs
  • Nervous system condition for example, migraine headaches, Parkinson’s disease, or Multiple sclerosis (MS)
  • Psychiatric condition, for example, bipolar disorder, schizophrenia, PTSD, or major depression

1Section 503 of the Rehabilitation Act of 1973, as amended. For more information about this form or the equal employment obligations of Federal contractors, visit the U.S. Department of Labor's Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.