Director, Clinical Science

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
• Clinical Scientist may also act as Medical Director and/or their delegate if they are qualified by experience, education and training
• 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 em