Job Description

ABOUT TRIVENI

Triveni Bio is breaking new ground in the identification of novel disease targets – working at the convergence of human genetics, best-in-class antibody design, and precision medicine. We are pioneering a Mendelian genetics-informed precision medicine approach to develop functional antibodies for the treatment of immunological and inflammatory (I&I) disorders. 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.

SUMMARY

Triveni Bio is seeking a Sr./Exec. Director, Nonclinical Development and Clinical Pharmacology, to lead our efforts across programs from development candidate selection to Investigational New Drug (IND) submission and early clinical studies. This individual is responsible for developing and executing the integrated nonclinical development plan for all programs and overseeing the clinical pharmacology function. They will also lead a cross-functional project team for one of the key programs, that include research, nonclinical, clinical, operations and finance functions.

RESPONSIBILITIES

• Oversee the translation of development candidates into viable clinical assets, ensuring that projects progress from preclinical stages through to IND submission and FIH studies
• Lead non-clinical development strategies/plans to enable clinical development and create robust value though preclinical, early clinical and late clinical development
• Ensure that all nonclinical development activities align with regulatory requirements for IND submissions and enable efficient progression through later steps of development
• Manage team of nonclinical and clinical pharmacology consultant advisors (pharmacokinetics, pharmacodynamics, toxicology, etc.) and take accountability for accuracy and completeness of timelines and budgets
• Lead a cross-functional program team for one of Triveni’s key programs; have accountability for the overall strategy and execution of this program and communication to leadership and the board
• Propose and lead the program team in vetting innovative development strategies to maximize value creation, investments that optimize timelines and allow parallel derisking
• Collaborate with CMO to set corporate goals including associated budgets, timelines, and capability build if needed
• Foster relationships with key stakeholders, including academic partners, contract research organizations (CROs), and regulatory agencies
• Drive scientific rigor and operational excellence within the pharmacology and nonclinical team, as well as across the entire organization
• Collaborate with CSO and research team on program/product strategy (e.g., to establish DC criteria, consider new program starts, etc.)
• Mentor and develop internal talent across organization, fostering a culture of innovation and collaboration

EXPERIENCE & QUALIFICATIONS

• Advanced degree in biomedical sciences, pharmacology, toxicology or related discipline
• 10+ years of relevant pharmaceutical or biotechnology industry experience with a strong background in non-clinical development, pharmacology or toxicology
• In depth knowledge of pharmaceutical drug development requirements for regulatory submissions, including GMP, GLP, GCP and the global regulatory process for product approval
• Proven experience leading and managing teams, setting goals and providing direction
• Excellent oral communication skills and an ability to speak across all levels both internally and externally
• Experience in developing and adhering to departmental budgets

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