Praxis Precision Medicines, Inc.
Director, DMPK
Praxis Precision Medicines, Inc., Boston, Massachusetts, us, 02298
Director, DMPKReports to: Head of Nonclinical Safety, Bioanalytical, DMPK & TranslationalLocation:
This position may be performed remotely with travel to the Boston area as needed.Position SummaryThe DMPK Director is responsible for representing the DMPK function on Praxis drug discovery, nonclinical and clinical project teams by providing DMPK-related guidance for the iterative drug discovery process. This role will be responsible for analyzing, synthesizing and interpreting DMPK data from hit identification to early clinical development and disseminating results in a collaborative, multidisciplinary team environment. Key deliverables are prediction of animal and human pharmacokinetics and toxicokinetics and projection of an efficacious human dose, in addition to early DDI risk and metabolic pathway predictions. This role includes working with various CROs on the in vitro and in vivo ADME, PK, PK/PD, and TK studies to ensure timely data-driven decision making.Primary ResponsibilitiesWork cross-functionally and closely with various disciplines involved in Praxis's drug discovery and development efforts, including biology, medicinal chemistry, bioanalytical, nonclinical safety and clinical pharmacology on strategy to advance small molecule drugs towards clinical studiesDefine plans for in vitro DDI and other in vitro/in vivo DMPK assessment for individual preclinical drug candidates and ensure timely availability of key dataCollaborate with CMC, analytical and bioanalytical teams to coordinate availability of appropriate reference materials, standards, bioanalytical methods and analyses.Effectively communicate DMPK-related data, its interpretation, and relevance to multidisciplinary project and leadership teamsOversee the design, execution and interpretation of in vitro, in silico and in vivo DMPK studiesApply current best practices for early prediction of animal and human PK dataDrive assessment of correlation between exposure & efficacy as well as exposure & toxicityAssess drug-drug interaction (DDI) risks early in the discovery processManaging external CRO vendors in the conduct of in vitro/in vivo studies and reporting processPrimary technical author for non-clinical ADME/DMPK sections of regulatory documents (e.g. IND, AR/DSUR, IB, etc.)Represent DMPK during interactions/presentations with Regulatory Agencies as a subject matter expert and function leaderQualifications and Key Success FactorsPh.D. in pharmacokinetics, drug metabolism, chemistry or related discipline and 5+ years of pharmaceutical/biotech industry experience in DMPK (or M.S. and 10+ years) is requiredCapability to evaluate and progress preclinical compounds into development candidates through in vitro and in vivo ADME profilingCommands an in-depth understanding of techniques used to predict animal and human pharmacokinetics including in vitro scaling, allometry and PBPK modeling.Adept at building and using PBPK models in SimcypExperience with the MetID in vitro and in vivo studies throughout the drug development processUnderstanding of DDI concepts including those involving metabolic and transporter mechanismsSuccessfully applies basic models to predict perpetrator and victim drug-drug interactionsDemostrated ability to provide oversight of outsourced DMPK studiesExcellent verbal and written communication skills as well as strong interpersonal skills are essential. Must be able to think critically in fast-paced projects with a keen sense of urgency and demonstrated ability to problem solve. Must have the ability to develop important relationships that include trust and encourage diversity in all its forms.Demonstrated success working in teams across multiple functional areas with a high level of intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit; experience working in,and can thrive in an agile environment.REQUIRED: The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position. Work is performed in a remote, work from home environment. The employee is regularly required to sit; use hands and fingers; reach with hands and arms; and talk and hear. The employee is occasionally required to stand, walk, and climb or balance. Movement through sites and labs may occasionally be required as employee may need to visit these environments. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus. Visual acuity is required to read and produce accurate materials. Use of keyboards and cellular devices.Compensation & BenefitsAt Praxis, were proud to offer an exceptional benefits package that includes:99% premium cost covered for medical (Blue Cross Blue Shield), dental, and vision plansBonus program structured to pay on a quarterly basis401k plan with 100% match up to 6% of employees contribution (Traditional & Roth)Wellness benefit of $200/month towards incredibly flexible options including travel, fitness equipment & memberships, student loan repayment, sports fees and much moreUnlimited PTO, (2) weeklong shutdowns each year, and a generous extended family leave benefitEligibility for equity awards and Employee Stock Purchase Plan (15% discount)To round out this world-class total rewards package, we provide base salary compensation in the range of $200,000 to $233,000 annualized. Final salary range may be modified commensurate with job level, education, and experience.
Company OverviewPraxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. At Praxis we share a common vision of reshaping the human condition into a more freeing and fulfilled existence by developing high impact medicines for patients and families affected by and living with complex brain disorders. Our core Values of
Trust ,
Ownership ,
Curiosity
and
Results
are foundational to every aspect of our business and are exemplified by each and every one of our team members.
Diversity, Equity & InclusionGuided by our core values, at Praxis Precision Medicines, Inc. we continue to DARE FOR MORE to advance, promote, and champion diversity, equity, and inclusion by encouraging individuals to bring their authentic selves and perspectives to work each day. We are an equal opportunity employer and committed to providing opportunities to all qualified applicants without regard to race, religious creed, color, gender identity or expression, age, national origin, sexual orientation, disability, genetics, military service and veteran status, or any other characteristic protected by federal, state, or local laws.
Attention: Job Scam AlertPraxis has recently become aware of fraudulent job recruitment postings from individuals claiming to represent Praxis. These postings seek financial information in connection with fraudulent opportunities for employment. If you suspect any fraudulent activity or misrepresentation in connection with a Praxis job opportunity, please report it to careers@praxismedicines.com.
Praxis does not accept unsolicited submissions from recruitment agencies for open positions.
We ask all recruitment agencies to refrain from contacting any Praxis employee regarding any position. All unsolicited resumes submitted by recruitment agencies to any Praxis employee in any form or method will be deemed to be the property of Praxis, and Praxis explicitly reserves the right to hire those candidate(s) without any financial obligation to the recruitment agency.
#J-18808-Ljbffr
This position may be performed remotely with travel to the Boston area as needed.Position SummaryThe DMPK Director is responsible for representing the DMPK function on Praxis drug discovery, nonclinical and clinical project teams by providing DMPK-related guidance for the iterative drug discovery process. This role will be responsible for analyzing, synthesizing and interpreting DMPK data from hit identification to early clinical development and disseminating results in a collaborative, multidisciplinary team environment. Key deliverables are prediction of animal and human pharmacokinetics and toxicokinetics and projection of an efficacious human dose, in addition to early DDI risk and metabolic pathway predictions. This role includes working with various CROs on the in vitro and in vivo ADME, PK, PK/PD, and TK studies to ensure timely data-driven decision making.Primary ResponsibilitiesWork cross-functionally and closely with various disciplines involved in Praxis's drug discovery and development efforts, including biology, medicinal chemistry, bioanalytical, nonclinical safety and clinical pharmacology on strategy to advance small molecule drugs towards clinical studiesDefine plans for in vitro DDI and other in vitro/in vivo DMPK assessment for individual preclinical drug candidates and ensure timely availability of key dataCollaborate with CMC, analytical and bioanalytical teams to coordinate availability of appropriate reference materials, standards, bioanalytical methods and analyses.Effectively communicate DMPK-related data, its interpretation, and relevance to multidisciplinary project and leadership teamsOversee the design, execution and interpretation of in vitro, in silico and in vivo DMPK studiesApply current best practices for early prediction of animal and human PK dataDrive assessment of correlation between exposure & efficacy as well as exposure & toxicityAssess drug-drug interaction (DDI) risks early in the discovery processManaging external CRO vendors in the conduct of in vitro/in vivo studies and reporting processPrimary technical author for non-clinical ADME/DMPK sections of regulatory documents (e.g. IND, AR/DSUR, IB, etc.)Represent DMPK during interactions/presentations with Regulatory Agencies as a subject matter expert and function leaderQualifications and Key Success FactorsPh.D. in pharmacokinetics, drug metabolism, chemistry or related discipline and 5+ years of pharmaceutical/biotech industry experience in DMPK (or M.S. and 10+ years) is requiredCapability to evaluate and progress preclinical compounds into development candidates through in vitro and in vivo ADME profilingCommands an in-depth understanding of techniques used to predict animal and human pharmacokinetics including in vitro scaling, allometry and PBPK modeling.Adept at building and using PBPK models in SimcypExperience with the MetID in vitro and in vivo studies throughout the drug development processUnderstanding of DDI concepts including those involving metabolic and transporter mechanismsSuccessfully applies basic models to predict perpetrator and victim drug-drug interactionsDemostrated ability to provide oversight of outsourced DMPK studiesExcellent verbal and written communication skills as well as strong interpersonal skills are essential. Must be able to think critically in fast-paced projects with a keen sense of urgency and demonstrated ability to problem solve. Must have the ability to develop important relationships that include trust and encourage diversity in all its forms.Demonstrated success working in teams across multiple functional areas with a high level of intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit; experience working in,and can thrive in an agile environment.REQUIRED: The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position. Work is performed in a remote, work from home environment. The employee is regularly required to sit; use hands and fingers; reach with hands and arms; and talk and hear. The employee is occasionally required to stand, walk, and climb or balance. Movement through sites and labs may occasionally be required as employee may need to visit these environments. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus. Visual acuity is required to read and produce accurate materials. Use of keyboards and cellular devices.Compensation & BenefitsAt Praxis, were proud to offer an exceptional benefits package that includes:99% premium cost covered for medical (Blue Cross Blue Shield), dental, and vision plansBonus program structured to pay on a quarterly basis401k plan with 100% match up to 6% of employees contribution (Traditional & Roth)Wellness benefit of $200/month towards incredibly flexible options including travel, fitness equipment & memberships, student loan repayment, sports fees and much moreUnlimited PTO, (2) weeklong shutdowns each year, and a generous extended family leave benefitEligibility for equity awards and Employee Stock Purchase Plan (15% discount)To round out this world-class total rewards package, we provide base salary compensation in the range of $200,000 to $233,000 annualized. Final salary range may be modified commensurate with job level, education, and experience.
Company OverviewPraxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. At Praxis we share a common vision of reshaping the human condition into a more freeing and fulfilled existence by developing high impact medicines for patients and families affected by and living with complex brain disorders. Our core Values of
Trust ,
Ownership ,
Curiosity
and
Results
are foundational to every aspect of our business and are exemplified by each and every one of our team members.
Diversity, Equity & InclusionGuided by our core values, at Praxis Precision Medicines, Inc. we continue to DARE FOR MORE to advance, promote, and champion diversity, equity, and inclusion by encouraging individuals to bring their authentic selves and perspectives to work each day. We are an equal opportunity employer and committed to providing opportunities to all qualified applicants without regard to race, religious creed, color, gender identity or expression, age, national origin, sexual orientation, disability, genetics, military service and veteran status, or any other characteristic protected by federal, state, or local laws.
Attention: Job Scam AlertPraxis has recently become aware of fraudulent job recruitment postings from individuals claiming to represent Praxis. These postings seek financial information in connection with fraudulent opportunities for employment. If you suspect any fraudulent activity or misrepresentation in connection with a Praxis job opportunity, please report it to careers@praxismedicines.com.
Praxis does not accept unsolicited submissions from recruitment agencies for open positions.
We ask all recruitment agencies to refrain from contacting any Praxis employee regarding any position. All unsolicited resumes submitted by recruitment agencies to any Praxis employee in any form or method will be deemed to be the property of Praxis, and Praxis explicitly reserves the right to hire those candidate(s) without any financial obligation to the recruitment agency.
#J-18808-Ljbffr