Senior Toxicology Strategy Lead

BlueRidge Life Sciences; Salem (NH); In loco; USD 180.000 - 280.000; Tempo pieno

Vantaggi offerti da questo lavoro

Health insurance

Descrizione del lavoro

BlueRidge Life Sciences is seeking a highly experienced toxicologist to join the ToxStrategies division in our pharmaceutical toxicology consulting practice. The candidate will leverage extensive biopharmaceutical experience to guide nonclinical safety assessments and regulatory strategies.

You will design and oversee safety programs, interpret complex data, and contribute to regulatory submissions and communications with agencies, while leading cross-disciplinary teams.

Competenze

• Ph.D. in toxicology, pharmacology, or related sciences.
• Minimum 15+ years in pharmaceutical consulting, industry or government.
• Strong understanding of ICH and regulatory guidance.
• Experience guiding nonclinical safety programs through all dev phases.
• Experience writing regulatory documents (pre-INDs, INDs, BLAs/NDAs).
• Excellent written and verbal communication; able to lead teams.

Mansioni

• Oversee design, data interpretation, and monitoring of toxicology studies.
• Write or oversee pharmacology/toxicology sections of regulatory submissions.
• Serve as toxicology expert on project teams; interact with regulators.
• Participate in meetings with global regulatory authorities.
• Lead business development activities to attract new projects.
• Travel may be required up to ~20%.

Conoscenze

Regulatory knowledge

Nonclinical safety

Project management

Communication skills

Team collaboration

Scientific publishing

Formazione

Ph.D. in toxicology / pharmacology

DABT certification desired

Descrizione del lavoro

BlueRidge Life Sciences is seeking a highly experienced toxicologist to join the ToxStrategies division in our pharmaceutical toxicology consulting practice. The candidate will leverage extensive biopharmaceutical experience to guide nonclinical safety assessments and regulatory strategies.

You will design and oversee safety programs, interpret complex data, and contribute to regulatory submissions and communications with agencies, while leading cross-disciplinary teams.