Director/Senior Director, Clinical Pharmacology

at  Blueprint Medicines

Cambridge, Massachusetts, USA - 02139

Start DateExpiry DateSalaryPosted OnExperienceSkillsTelecommuteSponsor Visa
Immediate19 Feb, 2022Not Specified21 Nov, 202110 year(s) or aboveCommunication Skills,Pharmaceutical Industry,Pharmacometrics,Pharmaceutical Sciences,Clinical Pharmacology,Writing,Drug DevelopmentNoNo
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Description:

Director/Senior Director, Clinical Pharmacology
Cambridge, MA
Requisition Number: 64
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?
The Head of Clinical Pharmacology leads a team of scientists responsible for developing, driving, and implementing global clinical pharmacology and pharmacometrics strategies for Blueprint clinical development programs. The individual is accountable for the characterization of all aspects of human pharmacology, including PK & metabolism, PKPD/exposure-response relationship assessment, clinical bioanalysis, and related internal and regulatory documentation. This role reports to the VP of Quantitative Pharmacology and Drug Safety (QPDS) and is a member of the QPDS leadership team, contributing to strategy development and execution of interrelated goals of the functions within QPDS (Preclinical Safety and Comparative Medicine, Pre-clinical in vivo Pharmacology, DMPK, and Clinical Pharmacology). In addition to collaborating with members of QPDS, the leader of Clinical Pharmacology also works in close collaboration with the leaders in Biology Drug Discovery, Translational Medicine, Clinical Research and Biostatistics to impact experiment/study design and facilitate line of sight from Discovery to Development in areas such as translational PKPD, bioanalytical chemistry, and model-informed drug development. The ideal candidate will contribute the vision, expertise, and urgency to enable scientifically sound, innovative, and efficient programs that meet regulatory requirements, advance the Blueprint portfolio, and deliver differentiated therapies to patients.

What will be your responsibilities?

  • Lead and manage the growing Clinical Pharmacology function: develop the skills and capabilities of a team of scientists, manage performance, design organizational structure, and actively recruit for open positions
  • Work with VP of QPDS to set a vision and articulate the mission for Clinical Pharmacology and develop plans to grow function’s capability and capacity commensurate with the needs of the portfolio
  • Partner with internal staff and external partners, oversee strategic planning and execution of clinical pharmacology and pharmacometrics activities
  • Manage resource allocation across the portfolio and contribute to ongoing management and annual planning of QPDS headcount and budget
  • Lead collaborations with other cross-functional leaders within Blueprint (e.g., Pharmaceutical Sciences, Biostats, Regulatory, Clinical Operations), as well as external partners
  • Represent QPDS on the Clinical Development Forum, providing Clinical Pharmacology expertise in review of clinical protocols and development plans
  • Act as a player-coach, maintain a level of hands-on responsibility for a portion of the portfolio while leading the function
  • As leader of a lean, but growing department, collaborate with Quality to establish standard methodologies for clinical pharmacology activities, including department SOPs, quality systems, plan/report templates, etc.
  • Oversee clinical pharmacology contributions to all regulatory documents. Direct and oversee the resolution of clinical pharmacology queries from drug regulatory agencies

What basic qualifications do we require?

  • PhD or MS plus equivalent experience in PK/PD, pharmaceutical sciences, or biomedical/chemical engineering
  • Director: PhD with 10+ or MS with 13+ years of proven experience in clinical pharmacology in biotech and/or pharmaceutical industry; Senior Director: PhD with 12+ or MS with 15+ years

What additional qualifications are we seeking?

  • Strong understanding of technical aspects standard methodologies in Clinical Pharmacology and Pharmacometrics, extensive experience in designing and executing clinical pharmacology studies, and a demonstrated ability to make data-driven decisions based on preclinical and clinical information
  • Experience leading clinical pharmacology aspects of programs at all stages of development is required; experience with writing and defending the clinical pharmacology sections of an NDA/BLA is strongly preferred
  • Experience overseeing scientific contributions and managing performance of scientific staff, with demonstrated record of developing talent
  • Strong interpersonal, collaborative, and communication skills; ability to articulate vision, inspire others, and deliver results
  • 3-5 years oncology experience is preferred; experience with small molecule drug development also preferred
  • Experience identifying, selecting, and overseeing the work of external CROs, consultants and partners (bioanalytical, pharmacometrics, clinical pharmacology) is preferred
  • Commitment to Blueprint Medicines’ Core Values: Patients First, Thoughtfulness, Urgency, Trust, and 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.

Responsibilities:

  • Lead and manage the growing Clinical Pharmacology function: develop the skills and capabilities of a team of scientists, manage performance, design organizational structure, and actively recruit for open positions
  • Work with VP of QPDS to set a vision and articulate the mission for Clinical Pharmacology and develop plans to grow function’s capability and capacity commensurate with the needs of the portfolio
  • Partner with internal staff and external partners, oversee strategic planning and execution of clinical pharmacology and pharmacometrics activities
  • Manage resource allocation across the portfolio and contribute to ongoing management and annual planning of QPDS headcount and budget
  • Lead collaborations with other cross-functional leaders within Blueprint (e.g., Pharmaceutical Sciences, Biostats, Regulatory, Clinical Operations), as well as external partners
  • Represent QPDS on the Clinical Development Forum, providing Clinical Pharmacology expertise in review of clinical protocols and development plans
  • Act as a player-coach, maintain a level of hands-on responsibility for a portion of the portfolio while leading the function
  • As leader of a lean, but growing department, collaborate with Quality to establish standard methodologies for clinical pharmacology activities, including department SOPs, quality systems, plan/report templates, etc.
  • Oversee clinical pharmacology contributions to all regulatory documents. Direct and oversee the resolution of clinical pharmacology queries from drug regulatory agencie


REQUIREMENT SUMMARY

Min:10.0Max:15.0 year(s)

Pharmaceuticals

Pharma / Biotech / Healthcare / Medical / R&D

Clinical Pharmacy

Phd

Proficient

1

Cambridge, MA, USA