Translational Lead, Early Clinical Development - Oncology

About Lindonlight

Lindonlight is dedicated to the discovery and development of transformative therapies for pediatric brain tumors. The organization operates as an integrated ecosystem comprised of the Lindonlight Foundation, Lindonlight Collective, and Lindonlight Bio. Within this ecosystem, Lindonlight Bio is focused on developing promising therapeutics for pediatric glioma.





Position Summary

We are seeking a Translational Lead, Early Clinical Development - Oncology who will play a central role in the early clinical development of Lindonlight’s oncology programs. This individual will be responsible for developing and executing translational and biomarker strategies that translate preclinical understanding of therapeutic assets into clinically actionable approaches.





The Translational Lead will work cross-functionally with research, clinical development, regulatory, and external partners to integrate translational science into early clinical development programs. The role will provide scientific leadership in biomarker strategy, patient selection, pharmacodynamic assessment, and proof-of-concept decision-making.





The ideal candidate will bring deep expertise in translational oncology and biomarker development, with experience supporting first-in-human and proof-of-concept oncology studies. This individual should be comfortable operating in a dynamic biotechnology environment and working across both internal and external teams to advance programs.





Responsibilities and Opportunities

· Develop and implement translational and biomarker strategies for oncology programs, ensuring alignment with clinical, regulatory, scientific, and business objectives.

· Translate preclinical biology, mechanism-of-action data, pharmacology, and disease biology into clinically actionable translational plans.

· Conduct and maintain ongoing assessment of the clinical and competitive landscape in pediatric glioma and other tumor indications.

· Maintain up-to-date knowledge of regulatory guidance and evolving requirements from FDA, EMA, CDE/NMPA, and other relevant health authorities, particularly those applicable to oncology, rare diseases, and pediatric drug development.

· Monitor and assess regulatory pathways and expedited development programs, including Fast Track, Breakthrough Therapy, Accelerated Approval, Orphan Drug, and other mechanisms relevant to rare and pediatric oncology indications.

· Translate emerging regulatory guidance into actionable development strategies, including requirements for pediatric clinical trials, pediatric study plans, trial design, patient eligibility, safety monitoring, biomarker development, and regulatory-enabling studies.

· Provide cross-functional input on regulatory considerations that may impact indication selection, clinical development plans, trial feasibility, biomarker strategies, and timelines for IND/CTA and subsequent regulatory submissions. Evaluate disease epidemiology to inform indication prioritization, trial feasibility, and site/patient-population strategy.

· Identify and evaluate biomarkers to support patient selection, pharmacodynamic assessment, efficacy evaluation, and understanding of mechanisms of response and resistance.

· Provide scientific input into the design and execution of first-in-human and proof-of-concept oncology studies.

· Partner with clinical development teams to incorporate biomarker and patient-selection strategies into clinical protocols.

· Develop translational endpoints and biospecimen collection strategies for early-phase clinical studies.

· Analyze and interpret emerging clinical data to inform program direction and development decisions.

· Work closely with research, clinical development, regulatory, pharmacology, bioinformatics, and other cross-functional teams to integrate preclinical insights into clinical development plans.

· Contribute to regulatory documents, including INDs, investigator brochures, clinical protocols, and regulatory briefing packages.

· Support interactions with regulatory agencies related to translational strategy, biomarkers, and early clinical development.

· Collaborate with external academic investigators, clinical partners, CROs, central laboratories, diagnostic companies, and other external partners.

· Provide scientific oversight of outsourced translational and biomarker activities.

· Support selection and management of external vendors and laboratories involved in biomarker development, assay execution, and clinical biospecimen analysis.

· Maintain awareness of advances in oncology, cancer biology, immuno-oncology, biomarker technologies, translational medicine, and precision medicine.

· Communicate translational findings, landscape assessment and indication recommendations clearly to cross-functional teams and senior leadership.

· Contribute to broader program strategy and development decision-making as programs advance.





Basic Qualifications/Requirements

· PhD or MD/PhD in Oncology, Cancer Biology, Immuno-Oncology, Molecular Biology, Translational Medicine, or a related scientific field.

· 10+ years of relevant biotechnology or pharmaceutical industry experience, with significant experience in translational oncology, biomarker development, or early clinical development.

· Experience contributing to INDs, regulatory briefing packages, investigator brochures, clinical protocols, or related regulatory documents.

Demonstrated experience developing and implementing biomarker strategies for oncology drug-development programs - including genomics, proteomics, tumor and immune profiling and applying findings to clinical development and program decision-making.

· Experience supporting first-in-human and early-phase oncology clinical studies.

· Strong experience with oncology biomarkers, strong understanding of oncology clinical landscapes, and disease epidemiology, with the ability to translate this into program strategy.

· Strong analytical skills with the ability to integrate complex preclinical, translational, biomarker, and clinical datasets. Experience working cross-functionally across research and clinical development teams.

· Experience managing CROs, external laboratories, academic collaborators, or diagnostic partners.

· Familiarity with regulatory requirements and guidelines related to oncology clinical trials, biomarkers, and translational research.

· Demonstrable ability to work proactively, independently, collaboratively, and tenaciously in an interdisciplinary, dynamic, fast-paced environment managing multiple priorities and external collaborations while maintaining focus on program timelines and development objectives

· Ability to identify scientific and operational challenges and develop practical solutions.

· Strong scientific, interpersonal, written, and verbal communication skills.





Additional Skills and Preferences

· Experience with pediatric oncology, glioma, brain tumors, or related areas is strongly preferred.

· Experience developing biomarker-driven or precision-medicine oncology programs is preferred.

· Experience with patient-selection strategies and companion or complementary diagnostic development is a plus.

· Experience working in a small or emerging biotechnology company is highly preferred.





Additional Information

· Reports to: Chief Executive Officer

· Job Type: Full-time, Hybrid schedule, 2-3 days on-site

· Schedule: Monday to Friday; flexibility outside of standard business hours as needed

· Work Hours: Requires flexibility to accommodate meetings and collaborations across U.S. and European time zones.

· Location: Cambridge, MA [Kendall Square]

· Travel: Approximately 10–15% Includes one week of monthly travel to Houston and occasional travel for scientific meetings or partnership engagements.

· Compensation: Expected base salary range: $220,000 - $320,000

Final salary will be determined based on the selected candidate’s experience, qualifications, location, and overall fit for the position.





Benefits

· 401(k) with company match

· Health, dental, and vision insurance

· Paid time off





Lindonlight is an equal opportunity employer and does not discriminate on the basis of race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or any other legally protected status.