Firefly Bio
Senior Vice President, Translational Biology
Firefly Bio, South San Francisco, California, United States, 94083
About Firefly Bio:
Who We Are At Firefly Bio, our mission is to redefine cancer treatment. We are developing a new class of therapeutics called Degrader Antibody Conjugates (DACs), which combine the precision of antibodies with the power of selective protein degraders. Our goal is to unlock new classes of payloads and deliver transformative medicines to patients. Our team operates with
F ocus,
I ntegrity,
R espect, and
E nergy. Position Summary: Firefly Bio is seeking a Senior Vice President (SVP) of Translational Biology to lead the end-to-end translational strategy from late discovery through Phase 1/2 clinical proof-of-concept across our DAC portfolio. This executive will serve as the bridge between discovery, clinical development, and regulatory, and will be accountable for: Defining and executing program translational plans, including: target engagement, PK/PD, exposure–response, biomarker/diagnostic strategy. Building and leading a best-in-class translational biology function spanning preclinical pharmacology, clinical biomarkers and bioanalytics, clinical pharmacology/modeling, and companion diagnostics (CDx). Supporting relevant sections of regulatory submissions with relevant data and designs. The ideal candidate is a seasoned oncology translational executive with deep experience in in both cancer biology and ADCs/bioconjugates. The person will have led hands-on clinical translation, including clinical bioanalytics, immunogenicity risk management, diagnostic co-development, and population PK/QSP modeling. The role requires an action-oriented leader who builds and scales high-performing teams, sets clear priorities, ensures accountability, delegates effectively, empowers others, and makes crisp decisions. This person values collaborative problem-solving and welcomes input from across the organization. Responsibilities: Own translational strategy for each DAC candidate, from DC selection to Phase 1/2 PoC, defining coverage, antigen thresholds, internalization, release kinetics, and dose/schedule. Build and lead a unified translational team across preclinical pharmacology, biomarkers, combinations, clinical pharmacology/modeling, and CDx. Develop exposure–response models to set starting dose, guide escalation, and select RP2D. Align with Discovery, Regulatory, and Clinical teams on integrated development plans. Define and execute biomarker/CDx strategy; lead analytical/clinical validation, submissions, and manage CRO/CDx partners. Lead authoring of IND/CTA translational content; author/defend clinical pharmacology and biomarker sections; drive FDA/EMA interactions with Regulatory. Partner with Regulatory on CDx agency strategy; author interaction documents and submission content. Communicate strategy and decisions to executives, board, investors, and partners; build and maintain KOL networks in ADCs/bioconjugates and diagnostics. Requirements and Experience: Ph.D., M.D., or M.D./Ph.D. in Biology/Molecular Biology or related, with strong drug development expertise. 15+ years in clinical pharmacology and oncology; 8+ years leading ADC/bioconjugate translation, with deep cancer biology experience. Led at least two ADC programs from IND/CTA into Phase 1 as the Translational Lead. Proven cross-functional leadership at the discovery–development interface within oncology. Designed prospective patient-selection strategies and delivered an analytically and clinically validated CDx with an external partner. Hands-on development of bioanalytics, immunogenicity strategy, and application of preclinical PK/PD to early oncology dose selection. Contributor to health-authority engagements with ownership ofIND/CTA translational components: clinical pharmacology, biomarker/CDx, and translational tox. Built and led a multidisciplinary translational organization Proven leadership of health-authority engagements (FDA/EMA or equivalent) and ownership of IND/CTA translational components (clinical pharmacology, biomarker/CDx, translational tox). Benefits: Every team member is essential in shaping Firefly Bio's culture and science, and for our success. We offer competitive compensation packages including stock options and the opportunity to be part of ground-breaking research. Firefly Bio is an equal opportunity employer and will consider all applicants for employment. Firefly Bio does not discriminate based on race, sex, color, religion, age, national origin, marital status, disability, veteran status, genetic information, sexual orientation, gender identity, or any other reason prohibited by law in the provision of employment opportunities and benefits.
F ocus,
I ntegrity,
R espect, and
E nergy. Position Summary: Firefly Bio is seeking a Senior Vice President (SVP) of Translational Biology to lead the end-to-end translational strategy from late discovery through Phase 1/2 clinical proof-of-concept across our DAC portfolio. This executive will serve as the bridge between discovery, clinical development, and regulatory, and will be accountable for: Defining and executing program translational plans, including: target engagement, PK/PD, exposure–response, biomarker/diagnostic strategy. Building and leading a best-in-class translational biology function spanning preclinical pharmacology, clinical biomarkers and bioanalytics, clinical pharmacology/modeling, and companion diagnostics (CDx). Supporting relevant sections of regulatory submissions with relevant data and designs. The ideal candidate is a seasoned oncology translational executive with deep experience in in both cancer biology and ADCs/bioconjugates. The person will have led hands-on clinical translation, including clinical bioanalytics, immunogenicity risk management, diagnostic co-development, and population PK/QSP modeling. The role requires an action-oriented leader who builds and scales high-performing teams, sets clear priorities, ensures accountability, delegates effectively, empowers others, and makes crisp decisions. This person values collaborative problem-solving and welcomes input from across the organization. Responsibilities: Own translational strategy for each DAC candidate, from DC selection to Phase 1/2 PoC, defining coverage, antigen thresholds, internalization, release kinetics, and dose/schedule. Build and lead a unified translational team across preclinical pharmacology, biomarkers, combinations, clinical pharmacology/modeling, and CDx. Develop exposure–response models to set starting dose, guide escalation, and select RP2D. Align with Discovery, Regulatory, and Clinical teams on integrated development plans. Define and execute biomarker/CDx strategy; lead analytical/clinical validation, submissions, and manage CRO/CDx partners. Lead authoring of IND/CTA translational content; author/defend clinical pharmacology and biomarker sections; drive FDA/EMA interactions with Regulatory. Partner with Regulatory on CDx agency strategy; author interaction documents and submission content. Communicate strategy and decisions to executives, board, investors, and partners; build and maintain KOL networks in ADCs/bioconjugates and diagnostics. Requirements and Experience: Ph.D., M.D., or M.D./Ph.D. in Biology/Molecular Biology or related, with strong drug development expertise. 15+ years in clinical pharmacology and oncology; 8+ years leading ADC/bioconjugate translation, with deep cancer biology experience. Led at least two ADC programs from IND/CTA into Phase 1 as the Translational Lead. Proven cross-functional leadership at the discovery–development interface within oncology. Designed prospective patient-selection strategies and delivered an analytically and clinically validated CDx with an external partner. Hands-on development of bioanalytics, immunogenicity strategy, and application of preclinical PK/PD to early oncology dose selection. Contributor to health-authority engagements with ownership ofIND/CTA translational components: clinical pharmacology, biomarker/CDx, and translational tox. Built and led a multidisciplinary translational organization Proven leadership of health-authority engagements (FDA/EMA or equivalent) and ownership of IND/CTA translational components (clinical pharmacology, biomarker/CDx, translational tox). Benefits: Every team member is essential in shaping Firefly Bio's culture and science, and for our success. We offer competitive compensation packages including stock options and the opportunity to be part of ground-breaking research. Firefly Bio is an equal opportunity employer and will consider all applicants for employment. Firefly Bio does not discriminate based on race, sex, color, religion, age, national origin, marital status, disability, veteran status, genetic information, sexual orientation, gender identity, or any other reason prohibited by law in the provision of employment opportunities and benefits.