Medical Director AllergyImmunology Pulmonology or Dermatology
Medical Director AllergyImmunology Pulmonology or Dermatology
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Job Description
How will your role help us transform hope into reality
The Medical Director with a focus on Allergy & Immunology Pulmonology or Dermatology will play a crucial role in providing strategic leadership and oversight in clinical programs from firstinman through global filings. Responsibilities include supervising design and writing of clinical study protocols from early phase 1 through phase 3 pivotal studies and providing subjectmatter expertise to the internal Research and Development teams from Clinical Development Planning through regulatory approval. You will be the primary interface with the external community for Blueprint in the therapeutic area for the programs you support.
You will join Blueprint during a significant expansion into multiple Allergic and Immune disorders built upon the leadership position Blueprint has in Systemic Mastocytosis.
What will you do
- Provide strategic leadership in the existing and planned clinical programs to support global filings
- Supervise the design and writing of clinical study protocols from firstinhuman phase 1 through phase 2 and phase 3 pivotal studies that will support regulatory approvals
- Medical monitor for multiple ongoing clinical trials including evaluation of clinical and laboratory data assessing safety and assessing early pharmacodynamics and clinical signals of activity
- Potential to supervise a team of Medical Monitors and Clinical Scientists leading studies across a clinical program (dependent upon experience)
- Coordinate activities with translational medicine colleagues to develop biomarker strategies for and interpret data generated from clinical trials
- Writing clinical sections of key documents including Investigators Brochures IND summary documents CTAs for initiation of studies exUS responses to questions from regulatory authorities IRBs and ethics committees and NDAs
- Provide medical review assessment and interpretation of all clinical data reported in clinical study reports to ensure that the data are correct and presented with the appropriate medical interpretation
- Attending and supporting clinical site initiation visits
- Work closely with Blueprint R&D team regulatory affairs and consultants to assure timely filing of all clinical applications
- Work closely with Pharmacovigilance on development of Risk Management Plans
- Ensure consistent practices with the highest ethical standards in compliance with internal SOPs local regulations and laws
- Perform other responsibilities as assigned
What minimum qualifications do we require
- M.D. D.O. N.P. or comparable advanced practice degree with experience in Allergy/Immunology Pulmonology Dermatology or Oncology/Rare Disease with experience in Allergy/Immunology drug development
- 3 years of proven ability in the biotechnology or pharmaceutical industry including direct experience leading a thorough understanding of the drug development process from IND through NDA including novel clinical study designs application of companion diagnostics for patient selection clinical operations and pharmacovigilance.
What additional qualifications will make you a stronger candidate
- Strong leadership skills and proven biopharmaceutical industry experience developing planning designing and executing early or latestage programs
- Experience leading clinical aspects of interactions with Regulatory Authorities such as the FDA and EMA
- Experience presenting to a wide variety of audiences including internal teams and medical/scientific communities
- Excellent interpersonal and communication skills with the ability to relate to both internal and external partners
- Ability to travel domestically and internationally approximately 25
- At home in a highly accountable environment where you can make a clear impact
- Commitment to our Core Values: Patients First Thoughtfulness Urgency Trust Optimism
Why Blueprint
At Blueprint Medicines we achieve impactful results because of our global crew of compassionate innovators the Blue Crew. Through authentic relationships and our collective entrepreneurial spirit and action we are each empowered to take ownership and execute with strategic prioritization. We put trust in our people to break through norms and conventions using their individual strengths and insights which drives our success.
This is the place where the extraordinary becomes reality and you could be part of it.
Patients are waiting. Are you ready to make the leap
Equity Diversity Inclusion and Affirmative Action
At Blueprint Medicines we foster a culture of equity diversity and inclusion. A proud Equal Employment Opportunity and Affirmative Action employer we consider all qualified applicants without regard to race color sex gender identity or expression sexual orientation age religion national origin ancestry ethnicity disability veteran status genetic information or any other characteristic protected under applicable law. We are also an EVerify Employer. We will make reasonable accommodations absent undue hardship for qualified individuals with known disabilities. If you are an individual with a disability in need of an accommodation with the application or recruiting process please reach out to
For more information please see ourEEOAA Policy Statement the EVerify Participation Poster the Right to Work Poster and/or theEEO Know Your Rights Poster as well as ourPay Transparency Statement.
Blueprint Medicines is a global fully integrated biopharmaceutical company that invents lifechanging medicines. We seek to alleviate human suffering by solving important medical problems in two core focus areas: allergy/inflammation and oncology/hematology. Our approach begins by targeting the root causes of disease using deep scientific knowledge in our core focus areas and drug discovery expertise across multiple therapeutic modalities. We have a proven track record of success with two approved medicines including bringing our medicine to patients with systemic mastocytosis (SM) in the U.S. and Europe. Leveraging our established research development and commercial capability and infrastructure we now aim to significantly scale our impact by advancing a broad pipeline of programs ranging from early science to advanced clinical trials in mast cell diseases including SM and chronic urticaria breast cancer and other solid tumors.
#LIHybrid #LIAQ1
Required Experience:
Director
Employment Type
Full Time
