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• Senior Director, Clinical Development

Senior Director, Clinical Development

Description

Blueprint Medicines is a top-tier, innovative, public biopharmaceutical company focused on discovering, developing and commercializing highly-selective kinase inhibitors for genomically defined diseases. Originally funded by Third Rock Ventures, the company has built a one-of-kind annotated compound collection which is delivering a pipeline of novel therapies, and a sophisticated genomics platform.

This is an excellent opportunity for a physician with experience in oncology clinical development to work within a rapidly growing company. The Senior Director, Clinical Development is responsible for designing and executing clinical studies, helping to create the clinical development plan for new compounds, and to pave a path towards regulatory approval. The Blueprint Medicines pipeline is currently focused in research and early clinical development; therefore the physician will work closely with scientists in discovery research and translational medicine, as well as non-clinical safety, DMPK/clinical pharmacology, biostatistics, clinical operations, and commercial development. The physician will also lead and participate in teleconferences with academic study investigators, advisory meetings with opinion leaders, and interactions with Health Authorities. The physician will interact closely with the company management team. A genuine interest and understanding of the science supporting the Blueprint Medicines pipeline, an ability to work collaboratively in a highly matrixed, multidisciplinary team setting, and a commitment to developing new treatments for patients with cancer are critical for success.

Responsibilities:

• Hands-on involvement in the design and writing of oncology clinical study protocols from first-in-human phase 1 through phase 2 and phase 3 pivotal studies that will support regulatory approvals
• Medical monitor for multiple ongoing clinical trials, including evaluation of clinical and laboratory data, assessing safety, responsibility for dose escalation decisions in phase 1, and assessing early pharmacodynamics and clinical signals of activity
• Writing clinical sections of key documents, including Investigatorrochures, IND summary documents, CTAs for initiation of studies ex-US, responses to questions from regulatory authorities, IRBs and ethics committees, and NDAs
• Leading regular teleconferences with academic clinical investigators
• Attending and supporting clinical site initiation visits
• Provide strategic leadership in the existing and planned clinical programs to support global filings
• Provide medical review, assessment and interpretation of all clinical data reported in clinical study reports to ensure that the data are correct and presented with the appropriate medical interpretation
• Work closely with Blueprint R&D team, regulatory affairs, and consultants to assure timely filing of all clinical applications
• Work closely with Pharmacovigilance on development of Risk Management Plans
• Ensure consistent practices with the highest ethical standards in compliance with internal SOPs, local regulations and laws.
• Serve as the clinical face of the company both internally and externally, including the scientific community and key opinion leaders

Qualifications:

• An M.D. with Board Certification or Board Eligibility in adult or pediatric oncology and/or hematology
• Strong leadership skills and proven biopharmaceutical industry experience developing, planning, designing and executing early and late stage programs. Experience with high-complexity first-in-human studies is highly desired
• 5 yearsperience in the biotechnology or pharmaceutical industry including direct experience leading Thorough understanding of the drug development process from IND through NDA, including novel clinical study designs, application of companion diagnostics for patient selection, clinical operations and pharmacovigilance
• Experience presenting to a wide variety of audiences including internal teams and medical/scientific communities

Capabilities:

• Excellent interpersonal and communication skills with ability to relate to both internal and external stakeholders
• Ability to travel domestically and internationally, approximately 25%
• At home in a results-driven, highly accountable environment where you can make a clear impact
• A team player, who listens effectively and invites response and discussion
• A collaborator who communicates in an open, clear, complete, timely and consistent manner

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 Medicinesssion 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 donhink 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.