Director, Preclinical Drug Safety

6 days ago

Cambridge, United States Blueprint Medicines Full time

How will your role help us transform hope into reality?



Scroll down the page to see all associated job requirements, and any responsibilities successful candidates can expect.

Reporting to the Vice President of Preclinical Drug Safety, you will be responsible for developing and implementing toxicology strategies for multi-disciplinary program teams. You will play a critical role helping derisk and advance the research pipeline by leveraging your toxicology expertise, including a blend of in-vitro and in-vivo skills. You will be a key member of the Quantitative Translational Pharmacology (QTP) group, which includes In-vivo Pharmacology, DMPK, Preclinical Drug Safety, and Clinical Pharmacology. Representing Preclinical Drug Safety on project teams, you will collaborate with stakeholders within and outside of QTP and facilitate line of sight from research to early development. These collaborations will include target safety evaluation, lead identification and optimization, development candidate (DC) nomination, and IND submissions. You will provide technical expertise and bring a sense of urgency to help project teams advance the Blueprint portfolio and deliver differentiated therapies to patients.


What will you do?


  • Help develop and lead the general toxicology strategy for Preclinical Drug Safety.
  • Help preclinical project teams navigate compound safety risks through various stages of drug discovery and development, including development candidate (DC) nomination, by implementing a blend of computational, in-vitro, and in-vivo toxicology capabilities.
  • Design, monitor, and interpret toxicology and safety pharmacology data from investigative, non-GLP and GLP-compliant toxicology studies, conducted both internally and at CROs.
  • Provide toxicology support for regulatory submissions as needed, including the authoring of nonclinical safety sections of US and international regulatory applications, including IND/CTAs.
  • Participate in collaborations with other cross-functional leaders within Blueprint (e.g., Medicinal Chemistry, Biology, DMPK, Pharmaceutical Sciences, Regulatory, Quality), as well as external partners.
  • Provide mentoring support as needed for junior toxicologists and scientists.

What minimum qualifications do we require?


  • PhD in toxicology, pharmacology, or a related discipline with 8 years postgraduate and/or industry experience.

What additional qualifications will make you a stronger candidate?


  • Strong understanding of technical principles and basic methodologies for in-vitro and/or in-vivo pharmacology and toxicology in a pharmaceutical setting.
  • Experience in designing and executing nonclinical studies to characterize the pharmacologic/ toxicologic properties of compounds, including those at CRO's.
  • Demonstrated ability to interpret toxicology data in the context of a compound's pharmacokinetic profile.
  • Ability to successfully influence project teams and operate effectively in a matrixed environment.
  • Ability to thrive in a fast-paced, dynamic environment and deliver under tight timelines.
  • Demonstrated proficiency with basic project management skills.
  • Strong interpersonal, collaborative, and scientific communication skills.
  • Experience interacting with global regulatory authorities, having an understanding of the relevant international guidance and/or experience authoring relevant sections of later stage regulatory submissions (e.g., NDA/MAA).
  • Experience performing study monitoring at CRO's.
  • Experience managing other scientists.
  • Experience using computational toxicology skills to help build and use computer-based risk assessment tools.
  • 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 global, fully integrated biopharmaceutical company that invents life-changing 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.


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