Atlas Venture
Director, Clinical Pharmacology
Atlas Venture, Waltham, Massachusetts, United States, 02254
Company Address:
100 Beaver Street Suite 307, Waltham, MA 02453 United StatesAbout Triveni Bio
Triveni Bio is a biotech company pioneering a genetics-informed precision medicine approach to develop functional antibodies for the treatment of immunological and inflammatory (I&I) disorders.Job Description
Triveni Bio is working at the convergence of human genetics, best-in-class antibody design, and precision medicine to break new ground in discovering and developing novel treatments for diseases with substantial unmet need. Our lead antibody program (TRIV-509) targets kallikreins 5 and 7 (KLK5/7) to directly impact skin barrier function, inflammation, and itch – providing a meaningful and much needed potential treatment option for patients with atopic dermatitis and other barrier disorders including rare disease. Our pipeline includes a bispecific antibody that targets KLK7/5 and interleukin 13 (IL-13), combining a potential new mechanism with an established and efficacious anti-inflammatory approach.This Individual Will:Lead all Clinical Pharmacology activities across programs to create and conduct scientifically rigorous, efficient development plans optimized for each candidate and disease across all stages of drug development.Partner with clinical development, clinical operations, biostats, regulatory, nonclinical, and research to ensure seamless, efficient translation of novel candidates from late Discovery through Clinical Proof-of-Concept in I&I and rare diseases.Integrate data across preclinical DMPK, modeling and simulations, and bioanalytical to identify issues proactively, conduct risk assessments and drive development of contingencies while assuring each program remains in alignment with objectives.Design, author and review all clinical pharmacology sections of clinical protocols and other regulatory documents.Utilize scientific expertise to communicate key information/strategy to management, regulatory agencies, and external partners to drive program objectives and deliver potential new treatments to patients.The Qualifications We’re Seeking:MS/ME/PhD/PharmD, or equivalent with training in pharmacokinetics, pharmaceutical sciences, or related disciplines and 5+ years of drug development experience in Clinical Pharmacology translating candidates from preclinical through early clinical development.Strong working knowledge of pharmacokinetics and pharmacodynamics, immunogenicity, modelling and simulation; up-to-date knowledge of analysis, modeling and simulation methods and software.Knowledge of all regulatory guidance and requirements (ICH, GLP, GCP) and experience in preparing pharmacology submissions.Experience in monoclonal antibody development desirable; experience in I&I and/or rare disease clinical development a bonus.Experience managing collaborations with consultants, pharmaceutical partners, CROs, and other external organizations is desirable.Proactive mindset and ability to work independently with the desire to thrive in a dynamic and fast-paced biotech setting working on treatment for patients in need.A work style consistent with Triveni’s core values of Bold Rigorous Science, Open Collaboration, Kindness & Respect, and Patient Impact.
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100 Beaver Street Suite 307, Waltham, MA 02453 United StatesAbout Triveni Bio
Triveni Bio is a biotech company pioneering a genetics-informed precision medicine approach to develop functional antibodies for the treatment of immunological and inflammatory (I&I) disorders.Job Description
Triveni Bio is working at the convergence of human genetics, best-in-class antibody design, and precision medicine to break new ground in discovering and developing novel treatments for diseases with substantial unmet need. Our lead antibody program (TRIV-509) targets kallikreins 5 and 7 (KLK5/7) to directly impact skin barrier function, inflammation, and itch – providing a meaningful and much needed potential treatment option for patients with atopic dermatitis and other barrier disorders including rare disease. Our pipeline includes a bispecific antibody that targets KLK7/5 and interleukin 13 (IL-13), combining a potential new mechanism with an established and efficacious anti-inflammatory approach.This Individual Will:Lead all Clinical Pharmacology activities across programs to create and conduct scientifically rigorous, efficient development plans optimized for each candidate and disease across all stages of drug development.Partner with clinical development, clinical operations, biostats, regulatory, nonclinical, and research to ensure seamless, efficient translation of novel candidates from late Discovery through Clinical Proof-of-Concept in I&I and rare diseases.Integrate data across preclinical DMPK, modeling and simulations, and bioanalytical to identify issues proactively, conduct risk assessments and drive development of contingencies while assuring each program remains in alignment with objectives.Design, author and review all clinical pharmacology sections of clinical protocols and other regulatory documents.Utilize scientific expertise to communicate key information/strategy to management, regulatory agencies, and external partners to drive program objectives and deliver potential new treatments to patients.The Qualifications We’re Seeking:MS/ME/PhD/PharmD, or equivalent with training in pharmacokinetics, pharmaceutical sciences, or related disciplines and 5+ years of drug development experience in Clinical Pharmacology translating candidates from preclinical through early clinical development.Strong working knowledge of pharmacokinetics and pharmacodynamics, immunogenicity, modelling and simulation; up-to-date knowledge of analysis, modeling and simulation methods and software.Knowledge of all regulatory guidance and requirements (ICH, GLP, GCP) and experience in preparing pharmacology submissions.Experience in monoclonal antibody development desirable; experience in I&I and/or rare disease clinical development a bonus.Experience managing collaborations with consultants, pharmaceutical partners, CROs, and other external organizations is desirable.Proactive mindset and ability to work independently with the desire to thrive in a dynamic and fast-paced biotech setting working on treatment for patients in need.A work style consistent with Triveni’s core values of Bold Rigorous Science, Open Collaboration, Kindness & Respect, and Patient Impact.
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