How will your role help us transform hope into reality?

The Senior Medical Director, with a focus on Allergy & Immunology, will play a crucial role in providing strategic leadership and oversight in clinical programs from first-in-man through global filings. Responsibilities include supervising design and writing of clinical study protocols from early phase 1 through phase 3 pivotal studies and providing subject-matter 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 A/I 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 oncology clinical study protocols from first-in-human 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, responsibility for dose escalation decisions in phase 1, 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 Investigator’s Brochures, IND summary documents, CTAs for initiation of studies ex-US, 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.

 

What minimum qualifications do we require?

  • D., D.O., N.P., or comparable advanced practice degree with experience in Allergy/Immunology 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 late-stage 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 E-Verify 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 TotalRewards@blueprintmedicines.com. 

For more information, please see our EEO-AA Policy Statement, the EEO Know Your Rights Poster, as well as our Pay Transparency Statement. 

 

Blueprint Medicines is a fully integrated, commercial-stage, global biopharmaceutical company that invents life-changing medicines in two core, strategic areas of allergy/inflammation and oncology/hematology. We pursue discovery, development, and commercialization of therapies that potently and selectively target known drivers of disease, with focused investment in therapeutic areas where we can leverage our core expertise and business infrastructure to bring scale to our science. We are bringing an approved medicine to people living with systemic mastocytosis (SM) in the U.S. and Europe. Additionally, we have a pipeline of research and development programs that range from early science to advanced clinical trials in mast cell-mediated diseases, including SM and chronic urticaria, breast cancer, and other solid tumors vulnerable to CDK2 inhibition.

 

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