Medical Director/Senior Medical Director
Requisition Number: 205
Blueprint Medicines is a global precision therapy company that invents life-changing therapies for people with cancer and hematologic disorders. Applying an approach that is both precise and agile, we create medicines that selectively target genetic drivers, with the goal of staying one step ahead across stages of disease. Since 2011, we have leveraged our research platform, including expertise in molecular targeting and world-class drug design capabilities, to rapidly and reproducibly translate science into a broad pipeline of precision therapies. Today, we are delivering approved medicines directly to patients in the United States and Europe, and we are globally advancing multiple programs for genomically defined cancers, systemic mastocytosis, and cancer immunotherapy.
What will you do?
This is an excellent opportunity for a physician with experience in industry or academic hematology / oncology clinical development to work within a rapidly growing company dedicated to precision medicine. The Director/Senior Director, Clinical Development is responsible for designing and executing clinical studies, helping to build the clinical development plan for new compounds, and to pave a path towards regulatory approval. The Blueprint Medicines pipeline provides opportunities to work in early clinical development where 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, regulatory and commercial development. There are also opportunities to engage in peri- and post-approval studies across the lifecycle of a drug. 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 and hematologic disorders are critical for success.
What will be your responsibilities?
Provide strategic leadership in the existing and planned clinical programs to support global filings
Supervise 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
Potential to supervise a team of Medical Monitors leading studies across a clinical program (dependent upon experience)
Coordinate activities with translational medicine colleagues to develop biomarker strategies for and interpret data generated from clinical trials
Write clinical sections of key documents, including Investigator's Brochures, IND summary documents, CTAs for initiation of studies ex-US, responses to questions from regulatory authorities, IRBs and ethics committees, and NDAs
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
Attend and support clinical site initiation visits
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
What basic qualifications do we require?
An M.D., D.O., N.P., P.A. or comparable advanced practice degree, with experience in adult or pediatric oncology, hematology, or rare diseases
Strong leadership skills and proven biopharmaceutical industry experience developing, planning, designing and executing early and late stage programs.
2+ years of proven ability in the biotechnology or pharmaceutical industry including direct experience leading,OR 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 leading the clinical aspects of interactions with Regulatory Authorities, such as FDA and EMA.
Experience presenting to a wide variety of audiences including internal teams and medical/scientific communities
What additional qualifications are we seeking?
Experience with high-complexity first-in-human studies is highly desired
Expertise in benign and malignant hematologic diseases, or
Expertise in Lung Cancer
Expertise in precision oncology and targeted therapies
Translational research experience, including candidates with M.D./Ph.D.s, are highly desired
Commitment to Blueprint Medicines' Core Values: Patients First, Thoughtfulness, Urgency, Trust, Optimism
COVID-19 Vaccination Requirement
As a biotechnology organization, it is our responsibility to do everything we can to safeguard the health and safety of our workforce, our communities, and the patients we serve. That is why we require all employees to be fully vaccinated against COVID-19, unless we approve an exemption through a reasonable accommodation for certified health reasons or sincerely held religious beliefs. Accommodation requests for either of these reasons should be made to TotalRewards@blueprintmedicines.com.
Equity, Diversity, Inclusion and Affirmative Action
At Blueprint Medicines, we foster a culture of equity, diversity and inclusion. A proud Equal Employment Opportunity and Affirmative Action employer, we consider all qualified applicants without regard to race, color, sex, gender identity or expression, sexual orientation, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, or any other characteristic protected under applicable law. We are also an E-Verify Employer. We will make reasonable accommodations, absent undue hardship, for qualified individuals with known disabilities. If you are an individual with a disability who requires an accommodation with the hiring process or to perform any essential functions of the position for which you are applying, please reach out to TotalRewards@blueprintmedicines.com.
For more information, please see our EEO-AA-Policy-Statement, the EEO Poster and its Supplement, as well as our Pay Transparency Statement.
Who we are:
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 matters and that our success depends on our ability to work together in a diverse community. We believe we are at our best as a company when our employees are thriving and we foster a culture that provides opportunities to grow and develop professionally, while also having fun.
Blueprint Medicines Corporation