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.
Blueprint Medicines seeks an exceptional candidate for the Director of Clinical Operations. This position reports into the Senior Director of Clinical Operations. The right candidate will possess an in-depth understanding of Clinical Operations for successful execution of multiple Phase 1-3 clinical trials primarily in oncology and hematology indications.
Responsibilities of this position are both operational and strategic.
- As a Director, provides leadership within the clinical operations team to ensure consistent, efficient and timely delivery of multiple clinical trials as part of a clinical program.
- Has direct line management responsibilities for clinical operations staff including hiring, training, performance management and career development.
- Leads selection of CROs (and other vendors) and negotiates/approves contracts and/or work orders to ensure their proper integration across clinical trials
- Leads and reviews strategy for operational efficiency
- Leads SOP development and promotes standardized use of Clinical business tools.
- Reviews metrics and Key Performance Indicators (KPIs) to ensure oversight of clinical trial progress.
- Develops and manages clinical operations budgets for current year and long-range planning
- Ensures and oversees the execution of study timelines across a clinical program or programs.
- Conducts and leads operational and timeline feasibility/contingency planning for program Clinical Development Plans (CDPs) as part of a cross functional team.
- Oversees the clinical strategy and development to ensure consistency across program wide documents such as IB, informed consent forms, study guidelines, operations manuals, training materials.
- Presents program status to program team and upper management
- Prepares and delivers presentations of trial metrics and data for internal and external stakeholders (management teams, advisory boards, and scientific meetings).
- Minimum Education Required: Bachelor’s degree in a scientific discipline required. Advanced scientific degree is preferred.
- The candidate should ideally have 10-15+ years in Clinical Research/trial management with a minimum of 3 years of oncology/hematology experience across clinical phases and in multiple therapeutic areas.
- Experience in early phase trials and CRO management is a must.
- Experience in the management across a development program and participation in NDA/sNDA filing is preferred.
- International experience is preferred.
- Motivated self-starter who is capable of flourishing in a fast-paced small company environment.
- Creative problem solver with excellent communication skills.
- Strong interpersonal and organizational skills are needed, with a high degree of attention to detail.
- Has public Speaking skills to conduct and lead external and internal presentations.
- Ability to interact well with individuals at all team levels (e.g., Clinical scientist, Project leader, Physician, etc.).
- Ability to travel for up to 30% of time, both domestic and international, may be needed.
- Detailed knowledge of GCP and current US FDA regulations, and knowledge of other relevant global regulatory requirements.
All applicants will receive consideration for employment without regard to race, color, religion, sex, 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.