Senior/Executive Director Translational Science jobs in United States
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Firefly Bio · 4 weeks ago

Senior/Executive Director Translational Science

Firefly Bio is focused on redefining cancer treatment through innovative therapeutics. The Senior / Executive Director, Translational Science will design and execute the translational strategy for DACs, ensuring rigorous de-risking and positioning for clinical trials.

BiotechnologyMedical
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H1B Sponsor Likelynote

Responsibilities

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 us to select patients who are more likely to respond to our molecules
Identify, design, plan and establish cell-based and biochemical assays and support the team in assay development and optimization
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 our 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
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
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

Qualification

Ph.D. in cancer biologyBiopharma R&D experienceIND planningSubmissionsClinical biomarker workflowsLeadership experienceTranslational methodsCancer biology expertiseAI tools familiarityStrategic problem-solving skillsCommunication skills

Required

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)
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

Preferred

Familiarity/experience with AI tools for managing IND-enabling and clinical biomarker activities is highly desirable

Company

Firefly Bio

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Firefly Bio specializes in Degrader Antibody Conjugates (DACs) which combine the unique strengths of ADCs with selective protein degraders.

H1B Sponsorship

Firefly Bio has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (2)

Funding

Current Stage
Early Stage
Total Funding
$94M
2024-02-15Series A· $94M

Leadership Team

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Scott Hirsch
Chief Executive Officer
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Company data provided by crunchbase