Tbwa Chiat/Day Inc
Director/Sr. Director, Bioanalytical Sciences (Small Molecule Experience Preferr
Tbwa Chiat/Day Inc, Boston, Massachusetts, us, 02298
Director/Sr. Director, Bioanalytical Sciences (Small Molecule Experience Preferred)
Scorpion is a pioneering clinical-stage oncology company redefining the frontier of precision medicine to deliver optimized and transformational therapies for larger populations of patients with cancer. Scorpion has built a proprietary and fully integrated platform of the most advanced technologies across cancer biology, medicinal chemistry, and data sciences, with the goal of consistently and rapidly creating exquisitely selective small molecule compounds against an unprecedented spectrum of targets. Scorpion aims to leverage its platform to advance a broad pipeline of wholly owned, optimized compounds across three target categories: best-in-class molecules targeting validated oncogene targets; first-in-class molecules for previously undruggable targets; and first-in-class molecules for novel cancer targets.Job SummaryThe successful candidate will have a proven track record of working in the nonclinical DMPK and clinical PK/clinical pharmacology area supporting R&D programs. They will have experience with working in a highly collaborative team environment, interfacing with multiple departments across the organization and developing strategic relationships with preferred vendors. They will work closely with other clinical and nonclinical disciplines and ensure that objectives for programs are achieved.Key ResponsibilitiesContribute to the design of bioanalytical studies to understand the pharmacokinetics of moleculesRepresent bioanalytical sciences in multifunctional research and development project teams and in nonclinical and clinical study teamsCollaborate with other functions, particularly clinical pharmacology and DMPK/Toxicology to interpret nonclinical and clinical dataEnsure that appropriate bioanalytical support of DMPK/clinical PK/pharmacology studies are included in program plans and timelinesEnsure the quality of bioanalytical data and communicate results to internal and external stakeholdersEnsure that bioanalytical methods are developed and validated to required standardsContribute to the cross-functional preparation and review of technical reportsServe as a subject matter expert in composing responses to regulatory queriesIdentify, qualify, engage, and manage external providers of bioanalytical PK servicesProvide in-depth scientific expertise and technical leadership as well as resource and relationship management of external networksDeliver and communicate results to project teams and other stakeholders to enable decision makingRecommend, initiate, lead and champion new bioanalytical innovations from external, global and local sources to ensure cutting-edge science is applied to drug project issuesProvide scientific input into regulatory submissions, including clinical study reports, briefing documents, and responses to regulatory queriesProfessional Experience and QualificationsBS or higher in a relevant scientific disciplineA minimum of 10+ years in pharmaceutical/biotech R&D supporting nonclinical DMPK and the clinical PK pharmacology areaExperience conducting or supervising conduct of bioanalytical studies in support of nonclinical DMPK/Toxicology and clinical studies; contributing to nonclinical and clinical reports including relevant sections for regulatory submissionsStrong knowledge of bioanalytical sciences, including method development and validation and nonclinical and clinical study requirementsStrong analytical and problem-solving skills, with attention to detailHands on experience with bioanalytical studies and an in-depth understanding of design and execution for support of research and developmentExperience working with external vendors to provide bioanalytical support for programsHighly developed written and verbal communication skills, including ability to effectively articulate highly technical/complex scientific data and concepts to audiences with differing scientific and technical knowledgeUp to date knowledge on regulatory guidance related to bioanalytical support of clinical trialsTeam player with strong negotiation, problem-solving, and strategic influencing skillsStrong customer focus with the ability to have robust discussions with other stakeholders to ensure that project, scientific and resource demands are alignedTrack record of successful problem solving, high quality science and influencing of stakeholders, particularly in a drug project contextClear and open communication skills, and experience communicating across cross functional partnersScorpion Therapeutics Inc. is an Equal Opportunity Employer who strives to create and maintain a diverse working environment. We do not discriminate for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
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Scorpion is a pioneering clinical-stage oncology company redefining the frontier of precision medicine to deliver optimized and transformational therapies for larger populations of patients with cancer. Scorpion has built a proprietary and fully integrated platform of the most advanced technologies across cancer biology, medicinal chemistry, and data sciences, with the goal of consistently and rapidly creating exquisitely selective small molecule compounds against an unprecedented spectrum of targets. Scorpion aims to leverage its platform to advance a broad pipeline of wholly owned, optimized compounds across three target categories: best-in-class molecules targeting validated oncogene targets; first-in-class molecules for previously undruggable targets; and first-in-class molecules for novel cancer targets.Job SummaryThe successful candidate will have a proven track record of working in the nonclinical DMPK and clinical PK/clinical pharmacology area supporting R&D programs. They will have experience with working in a highly collaborative team environment, interfacing with multiple departments across the organization and developing strategic relationships with preferred vendors. They will work closely with other clinical and nonclinical disciplines and ensure that objectives for programs are achieved.Key ResponsibilitiesContribute to the design of bioanalytical studies to understand the pharmacokinetics of moleculesRepresent bioanalytical sciences in multifunctional research and development project teams and in nonclinical and clinical study teamsCollaborate with other functions, particularly clinical pharmacology and DMPK/Toxicology to interpret nonclinical and clinical dataEnsure that appropriate bioanalytical support of DMPK/clinical PK/pharmacology studies are included in program plans and timelinesEnsure the quality of bioanalytical data and communicate results to internal and external stakeholdersEnsure that bioanalytical methods are developed and validated to required standardsContribute to the cross-functional preparation and review of technical reportsServe as a subject matter expert in composing responses to regulatory queriesIdentify, qualify, engage, and manage external providers of bioanalytical PK servicesProvide in-depth scientific expertise and technical leadership as well as resource and relationship management of external networksDeliver and communicate results to project teams and other stakeholders to enable decision makingRecommend, initiate, lead and champion new bioanalytical innovations from external, global and local sources to ensure cutting-edge science is applied to drug project issuesProvide scientific input into regulatory submissions, including clinical study reports, briefing documents, and responses to regulatory queriesProfessional Experience and QualificationsBS or higher in a relevant scientific disciplineA minimum of 10+ years in pharmaceutical/biotech R&D supporting nonclinical DMPK and the clinical PK pharmacology areaExperience conducting or supervising conduct of bioanalytical studies in support of nonclinical DMPK/Toxicology and clinical studies; contributing to nonclinical and clinical reports including relevant sections for regulatory submissionsStrong knowledge of bioanalytical sciences, including method development and validation and nonclinical and clinical study requirementsStrong analytical and problem-solving skills, with attention to detailHands on experience with bioanalytical studies and an in-depth understanding of design and execution for support of research and developmentExperience working with external vendors to provide bioanalytical support for programsHighly developed written and verbal communication skills, including ability to effectively articulate highly technical/complex scientific data and concepts to audiences with differing scientific and technical knowledgeUp to date knowledge on regulatory guidance related to bioanalytical support of clinical trialsTeam player with strong negotiation, problem-solving, and strategic influencing skillsStrong customer focus with the ability to have robust discussions with other stakeholders to ensure that project, scientific and resource demands are alignedTrack record of successful problem solving, high quality science and influencing of stakeholders, particularly in a drug project contextClear and open communication skills, and experience communicating across cross functional partnersScorpion Therapeutics Inc. is an Equal Opportunity Employer who strives to create and maintain a diverse working environment. We do not discriminate for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
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