Medical Director/ Senior Medical Director

Blueprint Medicines Corporation Cambridge , MA 02138

Posted 6 days ago

Medical Director/Senior Medical Director

Cambridge, MA

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.

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Medical Director/Senior Medical Director

Jounce Therapeutics

Posted 1 week ago

VIEW JOBS 6/17/2022 12:00:00 AM 2022-09-15T00:00 Role / Responsibilities Jounce Therapeutics is very excited about INNATE, our Phase 1/2 clinical study of JTX-8064, the first tumor-associated macrophage candidate developed from Jounce's Translational Science Platform. We are seeking a motivated Medical Director to lead all clinical activities related to the program including contributing to development and execution of clinical development strategy, study oversight, and leadership of the clinical sub team for the JTX-8064 program. JTX-8064 is a humanized IgG4 monoclonal antibody designed to specifically bind to the macrophage receptor LILRB2, acting as a Macrophage Checkpoint Inhibitor. INNATE is the Phase 1/2 clinical study of JTX-8064 as a monotherapy and in combination with pimivalimab, Jounce's PD-1 inhibitor, in patients with advanced solid tumors. The study progressed quickly through dose escalation and is now enrolling in Phase 2 tumor specific expansion cohorts designed to demonstrate proof of concept. Jounce announced recently that two of 7 combination expansion cohorts met the prespecified response criteria to continue enrollment beyond the first stage of a Simon 2-stage design. Patients with PD-(L)1 inhibitor resistant tumors represent a large and growing unmet medical need. INNATE will also assess potential predictive biomarkers to guide future development, aligning with Jounce's philosophy of "developing the right immunotherapies for the right patients." Responsibilities: * Design innovative and feasible clinical trials in collaboration with program leadership, translational research, and clinical team members; * Author clinical trial documents including but not limited to protocols, charters, IND reports, process documents, meeting presentations, publications, and clinical sections of regulatory documents such as INDs, briefing books, clinical study reports, investigator brochures, annual reports and updates, and clinical sections of regulatory submissions to support product approvals; * Partner with Data Management for case report form (CRF) design, instructions for unique CRFs, and Data Quality Plan; * Interact frequently with investigators to share new scientific and clinical data and maintain enthusiasm and engagement to optimize clinical trial enrollment; * Participate actively as the clinical development expert in study implementation, study oversight and study medical monitoring; * Conduct regular review, analysis, and interpretation of study results; * Participate in tracking/analysis of any potential safety events across trials for JTX-8064; * Serve as primary point of contact for clinical study inquiries from site staff, CROs and site monitors regarding the study protocol, modifications to informed consent, and scientific or medically related questions; * Present at internal and external meetings (e.g., portfolio reviews, clinical advisory boards, investigator meetings, pre-study site selection visits and site initiation visits, Study Coordinator and CRA training, and internal and external medical/scientific meetings); * Maintain awareness and keep program team informed of internal and external developments that may impact the investigational agent Clinical Development Plan, including attendance at major scientific conferences, participation in competitive intelligence activities, and periodic literature review; * Maintain current knowledge of the external environment to ensure scientific innovations are considered and/or incorporated into clinical trial development strategy; * Participate in development of the long-range strategic plans for the assigned program(s), and * Lead clinical sub-team meetings. Qualifications * The candidate must have a Medical Degree.  Board certified in internal medicine (or pediatrics) and medical oncology or hematology (or pediatric oncology) would be preferable; * Candidate should have at least 2 or more years of industry/related experience in cancer related research, drug development and clinical development, preferably in immuno-oncology; * Good knowledge of clinical research and experience across Phase I - III drug development projects; * Experience working effectively on cross-functional teams (matrix organization) and with external vendors including Contract Research Organizations; * Familiarity with clinical trial design and experience authoring clinical trial protocols (Phase I or II); * Strong Scientific/ Translational experience and experience with biomarker strategies preferred; * Experience in the analysis and interpretation of clinical data and assessment of clinical relevance; * Comprehensive understanding of safety profiles and risks; * Well-versed in medical aspects of GCP, ICH, FDA, EMA, and other relevant guidelines; * Ability to work independently and to organize priorities and deliverables; and * Strong verbal and written skills. Statement Diversity and Inclusion Statement Jounce strives to create a workplace that reflects the diversity of cancer patients, and where all feel included and valued because of their differences. Actively including people who add to our culture and enhance our values leads to better decisions and outcomes for those we serve - patients, all patients. Beyond our walls, our focus is on addressing inequities in opportunities for STEM education, careers opportunities in Biotech, and access to cancer care. Equal Opportunity Employer Jounce Therapeutics is an equal opportunity employer and does not discriminate in its employment decisions on the basis of race, color, national origin, age, physical or mental disability, marital status, religion, creed, sex, or political beliefs. We offer a competitive salary and benefits package. All applicants should be legally entitled to work for any employer in the U.S. Company Summary Jounce Therapeutics, Inc. is a clinical-stage immunotherapy company dedicated to transforming the treatment of cancer by developing therapies that enable the immune system to attack tumors and provide long-lasting benefits to patients through a biomarker-driven approach. Jounce currently has multiple development stage programs ongoing while simultaneously advancing additional early-stage assets from its robust discovery engine based on its Translational Science Platform. Jounce's highest priority program, JTX-8064, is a LILRB2 (ILT4) receptor antagonist shown to reprogram immune-suppressive tumor associated macrophages to an anti-tumor state in preclinical studies. A Phase 1 clinical trial, named INNATE, for JTX-8064 as a monotherapy and in combination with JTX-4014, Jounce's internal PD-1 inhibitor, or pembrolizumab is currently enrolling patients with advanced solid tumors. Jounce's most advanced product candidate, vopratelimab, is a monoclonal antibody that binds to and activates ICOS, and is currently being studied in the SELECT Phase 2 trial. JTX-4014 is a PD-1 inhibitor intended for combination use in the INNATE and SELECT trials and with Jounce's broader pipeline. Additionally, Jounce exclusively licensed worldwide rights to JTX-1811, a monoclonal antibody targeting CCR8 and designed to selectively deplete T regulatory cells in the tumor microenvironment, to Gilead Sciences, Inc. Jounce Therapeutics Cambridge MA

Medical Director/ Senior Medical Director

Blueprint Medicines Corporation