Director/Senior Director, Translational Medicine

Stealth Startup (Biotech); Boston (MA); In loco; USD 200.000 - 300.000; Tempo pieno

Descrizione del lavoro

Stealth Startup (Biotech) seeks a Director/Senior Director of Translational Medicine to lead development from lead candidates to IND/first-in-human trials. You will define and drive the translational biomarker strategy, oversee assay development, and guide cross-functional teams across oncology indications.

The role includes shaping the IB, IND submissions, and clinical protocols, as well as mentoring a growing team of translational scientists in a fast-paced startup environment.

Competenze

• PhD with 8+ years translational medicine and biomarker development in biotech or biopharma.
• Track record in biomarker strategy for clinical trials in oncology or immunology.
• Hands-on leadership of IND-enabling work and first-in-human transition.
• Experience leading cross-functional teams with timelines and budgets.
• Understanding of clinical pharmacology concepts and dose selection for trials.
• Companion diagnostic strategy experience and regulatory considerations.
• Experience with biomarker-driven endpoints and health authority interactions a plus.
• People management experience including hiring PhD-level scientists.

Mansioni

• Own integrated development plan, timeline and budget for lead and pipeline programs from DC through first-in-human.
• Lead cross-functional program teams.
• Drive IND-enabling studies including non-GLP and GLP toxicology and nonclinical pharmacology package.
• Shape IB, IND, and clinical protocol with clinical/regulatory leads.
• Identify risks, mitigation plans, and go/no-go decisions at gates.
• Select/manage CROs, consultants, and academic collaborators.
• Represent program to executive team, investigators and partners.
• Set clinical biomarker strategy: target engagement, PD, patient selection, early efficacy, resistance mechanisms.

Conoscenze

Program leadership

Cross-functional leadership

IND-enabling work

Biomarker development

Biomarker assays

Clinical pharmacology concepts

Companion diagnostic strategy

Team leadership

Formazione

PhD in biology/drug development

Strumenti

ctDNA

Multiplex IHC/IF

High-plex protein assays

Descrizione del lavoro

A stealth startup biotech company that has just completed a $90MM Series A financing with top-tier healthcare-dedicated investors seeks a Director/Senior Director of Translational Medicine. The successful candidate will lead the company’s development programs from lead drug candidates (DCs) into first-in-human clinical trials, as well as supporting the translational medicine function as drug candidates advance in clinical development.

The opportunity

The company’s first development candidate is a T cell engager (TCE) designed for oncology and non-oncology indications. As the Program Leader, you are the accountable owner for taking it through IND/CTN-enabling work, IND/CTN submission and first-in-human dosing by year-end 2027. Additionally, as the program enters clinical trials you will define and lead the clinical biomarker approach. Moreover, you will support translational medicine work for new programs as additional development candidates are nominated.

Responsibilities:

Program leadership

• Own the integrated development plan, timeline and budget for the lead and pipeline programs, from DC through first-in-human.
• Lead the cross-functional program teams.
• Drive IND-enabling studies to completion, including non-GLP and GLP toxicology and the nonclinical pharmacology package.
• Shape the investigator brochure (IB), IND, and the clinical protocol with clinical and regulatory leads.
• Identify program risks early, set mitigation plans, and make clear go/no-go recommendations at each stage gate.
• Select and manage CROs, consultants, and academic collaborators supporting the program.
• Represent the program to the executive team, investigators, and potential partners.

Translational medicine

• Set the clinical biomarker strategy for the program: target engagement, pharmacodynamics, patient selection, early efficacy and resistance mechanisms, including T cell activation, cytokine release and target-cell depletion readouts.
• Build the translational evidence that links preclinical models to human dose prediction, dose selection and benefit-risk assessment.
• Lead biomarker assay development, validation and vendor selection and ensure assays are clinic-ready before first patient in.
• Define the sample collection and analysis plan for clinical trials, and own biomarker data interpretation as it reads out.
• Collaborate with toxicology in designing toxicology experiments and with clinical pharmacology in setting clinical dosing strategies.
• Lead translational research for pipeline programs as development candidates are nominated, including indication selection and biomarker hypotheses.
• Manage and mentor translational medicine scientists as the team grows.

Qualifications

Experience

• PhD in a relevant biology/drug development discipline, with 8+ years in translational medicine and biomarker development in biotech or biopharma.
• Track record in setting biomarker strategy for clinical trials in oncology, immunology, or both.
• Hands-on leadership of IND-enabling work and the transition of a molecule into first-in-human studies.
• Experience in leading cross-functional teams in a matrix, with accountability for timelines and budgets.
• Basic understanding in clinical pharmacology concepts, exposure/response analysis, and their application in designing dose regimens for nonclinical experiments and clinical trials.
• Companion diagnostic strategy experience, including partner selection and regulatory considerations.
• Working knowledge of molecular, tissue-based and proteomic biomarker platforms, such as ctDNA, multiplex IHC/IF and high-plex protein assays.
• Experience with biomarker-driven endpoints and health authority interactions is a plus.
• People management experience, including hiring and developing PhD-level scientists.

Leadership attributes

• Think as a program owner: weigh science, timeline, cost and risk together.
• Make decisions with incomplete data and communicate the reasoning clearly to scientific and non-scientific audiences.
• Collaborative and direct; build trust across functions and with external partners.
• Comfortable in a small company: set strategy and conduct detailed work when needed.