Senior Director, Translational Pharmacology

Clinical Dynamix, Inc.; Boston (MA); Sur place; USD 300 000 - 520 000; Plein temps

Résumé du poste

Clinical Dynamix, Inc. is seeking a Senior Director, Clinical Pharmacology to drive translational strategy across PK, TK and PD, biomarker development and biodistribution studies, delivering milestones from candidate selection to BLA.

The role may be based in Waltham, MA or Boulder, CO; office-based staff work three days a week. The successful candidate will lead a high-performing translational science team, oversee CROs, and ensure regulatory compliance across programs.

Qualifications

• PhD with 12+ years in Clinical Pharmacology and Translational Sciences, including antibodies.
• Experience in translational science with PK/TK/PD, biomarkers, biodistribution.
• Clinical immunology/inflammation/endocrinology exposure.
• Knowledge of GXP, FDA/ICH, and global regulatory requirements.
• Strong communication and leadership in a matrix organization.

Responsabilités

• Provide scientific oversight for translational BLA and IND enabling studies.
• Ensure compliance with regulatory standards for translational research.
• Mentor translational science team and manage CROs.
• Prepare PK, TK, PD, ADA reports for regulatory submissions.
• Collaborate with clinical development on translational components of trials.
• Lead cross-functional working groups and engage with KOLs.

Connaissances

PK modeling

PD principles

Biomarker development

Regulatory submissions

Team leadership

CRO management

Formation

PhD in a relevant field

Outils

Phoenix

R

NONMEM

Description du poste

Clinical Dynamix, Inc. is seeking a Senior Director, Clinical Pharmacology to drive translational strategy across PK, TK and PD, biomarker development and biodistribution studies, delivering milestones from candidate selection to BLA.

The role may be based in Waltham, MA or Boulder, CO; office-based staff work three days a week. The successful candidate will lead a high-performing translational science team, oversee CROs, and ensure regulatory compliance across programs.