Firefly Bio
Senior/Executive Director Translational Science
Firefly Bio, South San Francisco, California, us, 94083
Senior/Executive Director Translational Science
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 Focus, Integrity, Respect, and Energy (F.I.R.E.).
Position Summary As Firefly’s advances development candidates into IND-enabling studies, the Senior / Executive Director, Translational Science will help us to build a bridge between our science and the clinic. This leader will design and execute the translational strategy for our DACs, focusing on biomarker development, patient selection strategies, and defining the data package for IND-enabling studies. They will guide a small team in understanding the clinical potential of our molecules, ensuring each program is rigorously de-risked and positioned for success in clinical trials. The individual reports directly to the Chief Scientific Officer.
Key Responsibilities & Focus Areas
Assess target engagement and establish proof of MOA that our DACs are working similarly in patients as they have in preclinical models. Identify specific characteristics that could enable selection of patients more likely to respond to our molecules.
Direct assay development & optimization: identify, design, plan, and establish cell-based and biochemical assays and support the team in assay development and optimization.
Oversee target expression analysis: lead efforts for evaluation of antigen and target expression in cells and tissues.
Define the relationship between dose, target coverage, and clinical response to guide human dose selection and escalation strategy.
Address specific challenges associated with E‑R analysis of DACs, such as assessment of target degradation in clinical samples.
Operational Execution
Oversee in-house assay development (working with the Biology team), manage assay transfer/establishment/troubleshooting with clinical labs and work with CROs to perform immunogenicity testing, toxicology assessments and PK/PD modeling.
Author/review key regulatory documents, including the Pharmacology and Pharmacokinetics Written Summaries, Lab Manuals and the Investigator's Brochure (IB). Contribute to the Clinical Protocol.
Leadership
Lead, mentor, and inspire a high-performing team of scientists and establish a culture of innovation, accountability, and scientific excellence.
Advise on portfolio decision-making by providing expert biological insights and contributing to governance discussions.
The position is on‑site at Firefly’s South San Francisco headquarters and requires active engagement in leading and mentoring a scientific team.
Requirements and Experience
Ph.D. in cancer biology, pharmacology, cell and molecular biology, or related field.
10+ years of biopharma R&D experience with a track record of advancing programs from discovery into clinical testing.
6+ years of leadership with demonstrated success building and managing teams and leading cross‑functional programs.
Proven ability to lead IND planning and submissions for biologics, select and manage CROs, and integrate translational insights into program strategies.
Hands‑on experience establishing, implementing and executing upon clinical biomarker workflows.
Experience with translational methods and biomarker development, including bioinformatics, IHC, genomics, and proteomics.
Expertise in cancer biology and targeted therapies (ADCs, degraders, mAbs, or related modalities).
Familiarity/experience with AI tools for managing IND-enabling and clinical biomarker activities is highly desirable.
Established scientific and professional reputation based upon publications, presentations and industry relationships.
Strong communication, organizational, and strategic problem‑solving skills; ability to influence across functions and with executive stakeholders.
Seniority Level
Director
Employment Type
Full‑time
Job Function
Science and Research
Industries
Biotechnology Research and Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at Firefly Bio by 2x.
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Position Summary As Firefly’s advances development candidates into IND-enabling studies, the Senior / Executive Director, Translational Science will help us to build a bridge between our science and the clinic. This leader will design and execute the translational strategy for our DACs, focusing on biomarker development, patient selection strategies, and defining the data package for IND-enabling studies. They will guide a small team in understanding the clinical potential of our molecules, ensuring each program is rigorously de-risked and positioned for success in clinical trials. The individual reports directly to the Chief Scientific Officer.
Key Responsibilities & Focus Areas
Assess target engagement and establish proof of MOA that our DACs are working similarly in patients as they have in preclinical models. Identify specific characteristics that could enable selection of patients more likely to respond to our molecules.
Direct assay development & optimization: identify, design, plan, and establish cell-based and biochemical assays and support the team in assay development and optimization.
Oversee target expression analysis: lead efforts for evaluation of antigen and target expression in cells and tissues.
Define the relationship between dose, target coverage, and clinical response to guide human dose selection and escalation strategy.
Address specific challenges associated with E‑R analysis of DACs, such as assessment of target degradation in clinical samples.
Operational Execution
Oversee in-house assay development (working with the Biology team), manage assay transfer/establishment/troubleshooting with clinical labs and work with CROs to perform immunogenicity testing, toxicology assessments and PK/PD modeling.
Author/review key regulatory documents, including the Pharmacology and Pharmacokinetics Written Summaries, Lab Manuals and the Investigator's Brochure (IB). Contribute to the Clinical Protocol.
Leadership
Lead, mentor, and inspire a high-performing team of scientists and establish a culture of innovation, accountability, and scientific excellence.
Advise on portfolio decision-making by providing expert biological insights and contributing to governance discussions.
The position is on‑site at Firefly’s South San Francisco headquarters and requires active engagement in leading and mentoring a scientific team.
Requirements and Experience
Ph.D. in cancer biology, pharmacology, cell and molecular biology, or related field.
10+ years of biopharma R&D experience with a track record of advancing programs from discovery into clinical testing.
6+ years of leadership with demonstrated success building and managing teams and leading cross‑functional programs.
Proven ability to lead IND planning and submissions for biologics, select and manage CROs, and integrate translational insights into program strategies.
Hands‑on experience establishing, implementing and executing upon clinical biomarker workflows.
Experience with translational methods and biomarker development, including bioinformatics, IHC, genomics, and proteomics.
Expertise in cancer biology and targeted therapies (ADCs, degraders, mAbs, or related modalities).
Familiarity/experience with AI tools for managing IND-enabling and clinical biomarker activities is highly desirable.
Established scientific and professional reputation based upon publications, presentations and industry relationships.
Strong communication, organizational, and strategic problem‑solving skills; ability to influence across functions and with executive stakeholders.
Seniority Level
Director
Employment Type
Full‑time
Job Function
Science and Research
Industries
Biotechnology Research and Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at Firefly Bio by 2x.
#J-18808-Ljbffr