Cambridge , MA 02139
At Blueprint Medicines, as our name indicates, we are creating a blueprint for the future of healthcare. We are a leading company in the personalized medicine revolution by focusing on delivering new medicines that are targeted to the genetic driver of disease. We do this by leveraging our one-of-kind drug discovery platform to discover, develop and work to bring highly-selective kinase inhibitors to patients globally. This prolific scientific platform has enabled Blueprint Medicine to build a pipeline of novel therapies that span three distinct areas of medicine; genomically defined cancers, rare diseases and cancer immunotherapy.
Reporting to the CMO, the VP, Pharmacovigilance and Drug Safety will be responsible to develop Blueprint's global pharmacovigilance strategy, for the strategic implementation, execution and management of Pharmacovigilance and risk management activities, and for ensuring compliance with global regulations. He or she must effectively collaborate cross-functionally at all levels in the organization as well as with partners and Health Authorities. He or she must be comfortable evaluating the appropriate balance of risk and benefit according to the characteristics of the clinical indication being studied. The VP Pharmacovigilance and Drug Safety will lead and provide medical oversight for the pharmacovigilance, drug safety and risk management functions for investigational and, if approved, marketed products, ensuring proactive and timely signal detection and risk-benefit assessments. This individual should be a self-starter with excellent leadership and management capabilities who is seeking to be part of an innovative and fast-paced team to support the company's drug development and potentially commercial activities.
Oversees and directs all aspects of pharmacovigilance and risk management activities for investigational compounds and, if approved, marketed products; actively participates in oversight of patient safety in all clinical trials.
Designs, directs and conducts ongoing safety surveillance of company drug products using internal resources and external vendors to ensure delivery of high-quality pharmacovigilance services.
Negotiates contracts, interacts and supervises the activities of CROs and consultants for pharmacovigilance services.
Organizes and leads regular, cross-functional safety review and signal detection meetings for all investigational and, if approved, marketed drug products, updates senior management on changes in the risk-benefit profile of company drug products, and implements appropriate safety updates and risk mitigation plans.
Provides strategic planning, implementation, and management of drug safety activities to support clinical development of the Blueprint pipeline.
Provides oversight of all clinical safety activities including review and processing of SAEs and SUSARs, and preparation of case narratives and analyses of similar events.
Lead role to respond and resolve safety questions from regulatory authorities, as well as regulatory agency audits and inspections, and corrective action plans.
Directs the development, preparation and submission of periodic and annual safety reports (e.g., DSUR, PSUR, periodic line listings, NDA safety updates), and other reports as necessary.
Provides medical safety review for all critical documents for clinical development from submissions to initiate first-in-human studies through marketing applications and, if our products are approved, completion of any post-marketing requirements.
Ensures departmental budgets and schedules meet corporate requirements.
Manages internal staff and external contractors to ensure delivery of quality safety and pharmacovigilance services, including selecting, developing, training, and evaluating team to ensure the efficient operation of the drug safety function.
Monitors industry best practices and changes in global safety regulations and guidelines. Recommends changes and upgrades to existing departmental policies, SOPs and systems to ensure global safety regulatory compliance.
The role will require some travel (approximately 10-15%), and hiring and managing people.
M.D. or D.O. degree with post-graduate training in a medical specialty is required.
Minimum of 15+ years of progressive experience in pharmacovigilance / drug safety in a biotechnology or pharmaceutical company required.
Pharmacovigilance experience in oncology or other serious diseases is preferred.
Expert knowledge of FDA safety regulations, ICH Guidelines, EU GVP and other applicable regulatory guidance documents; expertise in global safety regulations and reporting requirements.
Knowledge of ARGUS or similar relational database applications used for safety reporting.
Expertise in clinical safety assessments, safety signal detection and risk management, including interactions with regulatory authorities
Executive gravitas with natural ability to communicate and influence effectively to varied audiences
Comfortable and adept at balancing risk and opportunity
Ability to manage and prioritize multiple matters simultaneously and to respond to rapidly shifting priorities in ambiguous or challenging situations while leading others through the ambiguity and change
Demonstrated ability to solve problems with innovative solutions along with strong organizational skills
Possess strong and dynamic leadership skills, with excellent written, verbal and presentation skills
Effective team player, who fosters collaboration within and across functional areas
Sound strategic evaluation, analysis, and decision-making skills
Ability to work in a dynamic, fast paced environment
All applicants will receive consideration for employment without regard to race, color, religion, sexual orientation, national origin, disability or protected veteran status.
WHO WE ARE:
Blueprint Medicines' mission is to dramatically improve the lives of patients with genomically defined diseases. Our singular focus is to use our deep understanding of the genetic blueprint of cancer and other diseases driven by the abnormal activation of kinases to craft highly selective medicines aimed at eradicating these diseases.
We don't think in small steps. We think in giant leaps.
We are driven by the pursuit of new ideas, new innovations, and new ways of thinking.
We know that what each and every one of us does matters and that our success depends on our ability to work together. We believe we are at our best as a company when our employees are thriving and foster a culture that provides opportunities to grow and develop professionally, while also having fun.