- Shaping the medical affairs strategy for one of our gene therapy programs, providing scientific and medical leadership, including refinement of strategic and launch plans.
- Being an integral member of our medical affairs strategy teams and actively partnering with other medical directors and medical affairs functions to ensure alignment and seamless execution of activities.
- Establishing, engaging with, and maintaining strong relationships with external KOLs.
- Supporting/Leading external advisory boards to interact with experts in the field, gathering strategic insights to inform medical/brand strategy and data generation/lifecycle management activities.
- Providing medical leadership for data generation/communication activities, including conducting gap analyses to evolve product data generation plans as required.
- Working as part of a highly matrixed organization to support the program goals and provide medical expertise to cross-functional teams, including developing and supporting training activities in collaboration with key stakeholders.
- Reviewing abstracts, publications, medical information letters, payer resources and other documents as needed as the subject matter expert.
- Supporting Medical, legal, Regulatory review for assigned projects.
- Clinical or industry experience in sickle cell disease, thalassemia, gene therapy, bone marrow transplant, or rare diseases (blood disorders).
- One of the following advanced degrees in life sciences: MD, DO, APRN, PA (PhDs & PharmDs with extensive relevant experience may be considered).
- At least 3+ years relevant industry or clinical experience (Heme-Onc Fellowship is applicable) is preferred.
- A highly analytical and scientific approach, with demonstrated ability to see the bigger picture, consider the medical implications and have a passion to understand and effectively communicate scientific and medical data to both internal and external medical stakeholders.
- Strong interpersonal and communication skills commensurate with the need to work closely with cross-functional partners and health care professionals.
- Ability to both develop and articulate vision while also being passionate about understanding all stakeholder perspectives to drive alignment and decision-making.
- High aptitude for attention to detail, demand for high-quality work, and sense of passion and urgency to achieve goals and improve the lives of patients.
- Comfortable with ambiguity and developing innovative approaches, ability to work independently and thrive in a fast-paced environment.
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vp clinical operations
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Walker Cole International Boston, United StatesWalker Cole International have been engaged on a confidential search for a Director of Quality Assurance to join a Gene Therapy company based on the East Coast, USA. · Ready to make your application Please do read through the description at least once before clicking on Apply. ...
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Vertex Pharmaceuticals, Inc Boston, United StatesJob Description · General Summary: The Director, Regulatory CMC (Chemistry Manufacturing Controls) is responsible for the development and implementation of post-approval global regulatory CMC strategies for a marketed cell and gene therapy product. This role provides regulatory g ...
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Head of Clinical Operations
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Partners Healthcare System Boston, United StatesPostdoctoral Fellowship in Inner Ear Regeneration · Harvard Medical School · Massachusetts Eye & Ear Infirmary · Postdoctoral positions are available on inner ear regeneration for hearing recovery from deafness, using reprogramming, animal models, and bioengineering approaches. · ...
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Vertex Pharmaceuticals Boston, United StatesSupply Chain Manager - Cell & Gene Therapy (Hybrid) page is loaded · Supply Chain Manager - Cell & Gene Therapy (Hybrid) · Apply · locations · Boston, MA · time type · Full time · posted on · Posted 6 Days Ago · job requisition id · REQ-21403 · Job Description · The Co ...
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Director, Medical Affairs Strategy, Gene Therapy - Boston, United States - bluebird bio, Inc.
1 week ago
Description
ABOUT THE FLOCK
bluebird bio is seeking an accomplished and adaptable Director Medical Affairs to join the medical affairs team, focused on our gene therapy programs for Sickle Cell, Beta Thalassemia, and CALD.
You will be joining a passionate and committed flock, flying closely with medical birds as well as the cross functional teams.
With three gene therapies approved within the last 2 years, and with the most recent launch for sickle cell disease in December 2023, this is an exciting time to join the nestYou will be instrumental in shaping strategy and executing the medical affairs plans for our various Gene Therapy programs.
Furthermore, you will be responsible for supporting brand priorities and tactics, engaging with key opinion leaders (in collaboration with the Medical Science Liaison team) to inform medical activities and evidence generation planning, evidence dissemination and working cross-functionally to align on team activities and to support education and training.
HOW YOU'LL FLY
You'll help to bring more patients their bluebird days through responsibilities including, but not limited to:
WHAT YOU'LL BRING
You're the bird we're looking for if you have:
Travel:
Up to 30%, as necessary
Location:
U.S. Remote
Compensation & Benefits
We offer a total compensation and rewards package that ranks among the best in our industry. Base pay is one part of our total compensation package and is determined within a range. This provides the opportunity to progress as you grow and develop within a role. The anticipated annualized salary range for a MD-qualified candidate in this role is $260,000-$305,000.
Your base pay will be determined based on several factors including market data, demonstrated skills, relevant education or training, experience, qualifications, internal equity, and travel requirements.
Our overall package also includes eligibility for stock, incentive bonuses, and benefit programs, a flexible time off program, as well as paid holidays, bluebird days, and a holiday shutdown in December.
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