Medical Director/Senior Medical Director, Solid Tumor Oncology

Location: Cambridge, MA

Requisition Number: 466

How will your role help us transform hope into reality?

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 paving 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 you do?

• 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
• 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 minimum qualifications do we require?

• An M.D., D.O., N.P., P.A. or comparable advanced practice degree
• 2-5 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
  • Medical Director – 2-3 years industry experience
  • Senior Medical Director – 3-5 years industry experience

What additional qualifications will make you a stronger candidate?

• Experience in adult or pediatric oncology, hematology, or rare diseases
• Expertise in solid tumor oncology, particularly Breast Oncology
• Expertise in Lung Cancer
• Strong leadership skills and proven biopharmaceutical industry experience developing, planning, designing and executing early and late stage programs.
• 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
• Experience with high-complexity first-in-human studies is highly desired
• 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
• Commitment to our 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, prior to their start date, new hires must provide confirmation that they are fully vaccinated against COVID-19, or be approved by Blueprint for an exemption for health reasons contraindicating the vaccines 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 in need of an accommodation with the application or recruiting process, 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.

Blueprint Medicines is a global precision therapy company that invents life-changing therapies for people with cancer and blood 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 systemic mastocytosis, lung cancer and other genomically defined cancers, and cancer immunotherapy. For more information, visit www.BlueprintMedicines.com and follow us on Twitter (@BlueprintMeds) and LinkedIn.