Associate Director / Director Clinical Scientist

KymaThera; United States; Sur place; USD 150 000 - 200 000; Plein temps

Résumé du poste

A clinical-stage biopharmaceutical company is seeking an Associate Director or Director of Clinical Science in the United States. This role involves leading clinical scientific execution for oncology trials, authoring protocols, and ensuring scientific rigor in regulatory submissions. The ideal candidate has an advanced degree, extensive clinical development experience, particularly in oncology, and the ability to collaborate effectively with cross-functional teams. A dynamic environment awaits where roles can evolve rapidly.

Qualifications

• 5-10+ years of clinical development experience in biotech or biopharma.
• Direct experience in oncology clinical development, especially Phase 1 trials.
• Demonstrated authorship of clinical protocols and regulatory documents.

Responsabilités

• Lead clinical scientific execution for Phase 1/2 oncology programs.
• Author and review clinical protocols and regulatory submissions.
• Provide oversight on adverse events and protocol deviations.
• Design and interpret PK/PD and efficacy analyses.
• Collaborate with KOLs and provide scientific input on site selection.

Connaissances

Clinical development

Oncology expertise

Regulatory knowledge

Scientific communication

Formation

MD, PharmD, or PhD in a relevant scientific discipline

Description du poste

KymaThera is a clinical-stage biopharmaceutical company developing targeted therapies for oncology and rare disease patients with high unmet need. We are building a lean, high-impact team committed to rigorous science and patient-centered development.

Position Summary

The Associate Director or Director of Clinical Science will serve as the scientific voice of KymaThera's clinical programs, driving protocol strategy and clinical data interpretation across our oncology FIH trial and expansion trials. The level of appointment (AD vs. Director) will be commensurate with experience. This individual will work closely with the CMO, Clinical Operations, Regulatory Affairs, and external clinical advisors to ensure that KymaThera's programs are scientifically rigorous, clinically meaningful, and regulatory-ready.

Key Responsibilities

• Lead clinical scientific execution for Phase 1/2 oncology and additional clinical programs.
• Author and critically review clinical protocols, amendments, investigator brochures (IB), and clinical sections of IND/CTA submissions.
• Provide clinical science oversight of adverse events, SAEs, and protocol deviations in close collaboration with the CMO and pharmacovigilance.
• Design and interpret PK/PD, biomarker, and efficacy analyses to inform dose selection and RP2D determination.
• Support dose escalation committee (DEC) meetings, synthesizing safety and PK data to support dose escalation decisions under BOIN design.
• Develop and maintain clinical pharmacology sections of regulatory submissions; support Pre-IND and Type B/C FDA meeting materials.
• Collaborate with KOLs and clinical advisors; provide scientific input on site selection and investigator training.
• Contribute to publications, conference abstracts, and investor-facing scientific communications.
• Support expansion planning into pediatric and adolescent populations, including PSP development.
• Monitor the competitive landscape in oncology and rare disease and provide strategic insight to the development team.

Required Qualifications

• Advanced degree required: MD, PharmD, or PhD in a relevant scientific discipline.
• 5-10+ years of clinical development experience; prior experience at a biotech or biopharma company required.
• Level of appointment (AD vs. Director) commensurate with depth of experience.
• Direct experience in oncology clinical development, including Phase 1 dose escalation trials.
• Rare disease clinical development experience required.
• Demonstrated authorship of clinical protocols, IBs, and regulatory documents (IND, CTA, NDA/BLA clinical sections).
• Deep working knowledge of GCP, ICH E6, and FDA/EMA regulatory frameworks.

Preferred Qualifications

• Experience with targeted therapy programs in rare or genomically-defined oncology or rare disease indications.
• Familiarity with model-based dose escalation designs (BOIN) and DLT assessment frameworks.
• Experience with SDLT/Severely Debilitating or Life-Threatening disease regulatory designations.
• Knowledge of ODD, BTD, PRIME, and PRV regulatory incentive frameworks.
• Experience supporting pediatric clinical development and PSP submissions.
• Scientific rigor paired with practical regulatory and operational judgment.
• Ability to distill complex clinical data into clear, actionable recommendations.
• Strong collaborative instincts across medical, regulatory, and operational functions.
• Comfortable in a lean startup environment where roles are broad and evolve rapidly.