DIRECTOR, CLINICAL SCIENCE

Company: Blueprint Medicines
Location: Cambridge
Posted on: August 31, 2024

Job Description:

How will your role help us transform hope into reality? The Director, Clinical Science will provide scientific support for all Clinical Development activities involving the conduct of clinical studies, including: clinical development plans, study design and feasibility, data collection requirements, analysis plans, preparation of meeting materials and internal/external presentations, lead development of key clinical documents (protocol/amendments, IB, CSR), safety and medical review, reporting of study results, and reviewing and summarizing relevant literature. Analyze and synthesize information to assess issues relating to protocol conduct and/or individual subject safety and assist in communicating a clear overview of trial results. You will report to the Sr. Director, Clinical Development and will collaborate with Clinical Pharmacology, Clinical Research, Translational Medicine, Regulatory Affairs, Biostatistics, Data Management and other functions as appropriate. What will you do?

• Work closely with Medical Directors, Pharmacology, Discovery, external experts, and investigators to accumulate scientific and medical knowledge necessary to support clinical development plans and study designs and protocols
• Assist Medical Directors in creation of proposed concept sheets for clinical studies and author protocols through incorporation of input from both internal and external experts
• Leads the annual update of IB with input from Toxicology, Pharmacology, Safety, Regulatory
• Review and interpret biomarker data and help revise clinical development strategy based upon results
• Author clinical protocols, amendments and investigators brochures with input from internal and external experts as appropriate, clinical abstracts for presentations at conferences when appropriate and provide input into informed consents documents
• Drive and integrates clinical contribution to answering regulatory queries and other submissions related to studies
• Monitor and review along with the medical monitor safety and efficacy data in ongoing clinical trials monitors GCP compliance with help of clinical operations and CRO
• Involved in high level data cleaning activities requiring interpretation and clinical judgment
• Involved in analysis of complex data for regulatory submissions, publications and design of studies and programs
• Attend scientific meetings to remain abreast of new developments within relevant areas and to interact with investigators, and advisors
• Work with investigative sites to answer protocol related questions, resolve study conduct and design issues
• Coach, mentor and supervise other Clinical Scientists
• Present data, protocol designs and other information at advisory boards, investigator meetings, site initiations and other internal and external settings
• Reviewer of CRFs, SAPs, TLFs, study manuals impacting endpoint assessment/data collection/analysis (ie, central imaging review charter, blinding plan, data transfer plans for central labs, etc.)
• Provide scientific and clinical development input into all other program documents in support of the development plan, including but not limited to informed consent forms (ICF), case report forms (CRF), statistical analysis plans (SAP), and clinical pharmacology/translational medicine plans
• Conduct literature and database research on providing background data for clinical trials, and regulatory documents as needed.
  What minimum qualifications do we require?
  • Advanced degree required (M.S., PharmD, or Ph.D.)
  • 7+ years of clinical drug development experience
    What additional qualifications will make you a stronger candidate?
    • Degree in scientific/life sciences/clinical/nursing field is preferred
    • Prior hematology or oncology drug development experience a plus
    • Ability to work in a highly collaborative, matrix environment with the ability to manage through conflict resolution
    • Excellent written and oral communication skills
    • Strong analytical ability, detail oriented, and proficiency in data management a plus
    • 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. #LI-Hybrid #LI-AQ1

Keywords: Blueprint Medicines, Cambridge , DIRECTOR, CLINICAL SCIENCE, Executive , Cambridge, Massachusetts