Sr. Director/VP Clinical Development
Blueprint Medicines is seeking a Sr. Director/VP Clinical Development to join the Clinical Development team and assist with the Clinical development of Blueprint’s drug portfolio, primarily in hematologic and oncologic malignancies, including several programs currently in the drug development process.
The Senior Director/ VP, Clinical Development will be responsible for the development and execution of clinical research and development sponsored and supported clinical programs for Blueprint Medicines. This individual, in conjunction with the SVP, Head of Clinical Development, will lead the strategic direction of one or more of Blueprint’s clinical programs and be a key driver in drug development for both time and quality. This position will help to develop and implement clinical strategies, serve as a liaison between company and clinical investigators and establish credible relationships with global key opinion leaders, patient advocacy groups, and study physicians. In addition, this individual will contribute key input for strategic development to discovery teams as to the clinical feasibility of targets and small molecules. This individual is responsible for ensuring that all clinical studies operate to the highest ethical and safety standards and in compliance with company, GCP and regulatory requirements.
• Direct responsible for the design, conduct, monitoring, data interpretation and reporting of individual clinical trials, especially POC/Phase I studies with a strong focus in the hematology/oncology therapeutic area
• Directly manage and monitor trial conduct as well as work closely with external medical monitor physicians to assure consistency of conduct and regulatory compliance across trials.
• Detects and analyzes emergent issues during clinical drug development and develops and implements mitigating strategies
• Work closely with all external vendors such as CROs, external imaging and laboratory resources, to manage trial logistics with optimal time and quality.
• Facilitates the development of key internal and external documents pertaining to product development including clinical study protocol, informed consents, CRFs, CSRs, meeting abstracts, scientific journal publications, strategy documents and clinical/project development plans
• Liaises with discovery science to facilitate and further the development of investigational agents from a preclinical stage to clinical development
• Support qualification of pharmacodynamics/disease markers for assessment of clinical efficacy
• Represents Blueprint Medicines at key national and international medical and scientific meetings including participation and/or leadership of advisory boards with key opinion leaders.
• Interact with global regulatory bodies including the FDA and EMA to accomplish tasks related to oncology product development and collaborates with internal regulatory experts and oversee the clinical research plans and sections for Investigational new Drug applications (INDs) and New Drug Applications (NDAs)
• Ensure consistent practices with the highest ethical standards in compliance with internal SOPs and FDA safety regulations.
• M.D. or equivalent degree
• Board Certification or experience in Hematology or Oncology is of particular value
• At least 4 years of clinical research expertise and experience within oncology drug development in a biotechnology or pharmaceutical company, including experience in designing, monitoring, executing and interpreting clinical trials, including understanding of biostatistics and safety reporting.
• Experience with early phase oncology clinical trials is ideal
• Some experience incorporating biomarkers into clinical trial of oncology drugs a plus
• Excellent interpersonal, oral and written communication skills
• Demonstrated ability to work in a matrix environment with cross-functional teams.
• Demonstrated leadership experience across functions
• Ability to multi-task and work in a fast-paced environment
• Up to 25% annual travel (domestic and international) is required for this position.