Director, Toxicology (Consultant) in India at Jobgether

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Director, Toxicology (Remote/ Consultant) based in India.

This role provides scientific leadership across nonclinical safety assessment activities supporting oncology drug development programs.
You will shape toxicology strategies, interpret complex safety data, and provide evidence-based recommendations throughout the development lifecycle.
The position combines scientific expertise, regulatory knowledge, strategic decision-making, and cross-functional collaboration.
You will guide the design and interpretation of a broad range of nonclinical studies, from acute and chronic toxicity to reproductive, developmental, genotoxicity, and carcinogenicity assessments.
Your assessments will help teams understand safety margins, characterize potential risks, and make informed development decisions.
You will also contribute directly to regulatory submissions and interactions with health authorities while overseeing external research partners.
This is an impactful opportunity for an experienced toxicology leader to influence oncology programs and advance scientifically rigorous safety strategies.

• Develop and implement comprehensive nonclinical toxicology strategies for oncology drug development programs.
• Serve as the toxicology subject matter expert, providing scientific safety assessments, development recommendations, and strategic guidance to cross-functional project teams.
• Design, oversee, and critically interpret nonclinical safety studies, including acute, subchronic, chronic, reproductive and developmental, genotoxicity, carcinogenicity, and other relevant assessments.
• Integrate animal, clinical, in vitro, in silico, exposure, and mechanistic data to establish scientifically sound conclusions and comprehensive safety assessments.
• Evaluate safety margins, identify and characterize potential hazards and risks, and provide benefit-risk recommendations that inform development decisions.
• Author, review, and provide scientific input into toxicology sections of INDs, CTAs, Investigator's Brochures, and other regulatory submissions.
• Support regulatory interactions and ensure nonclinical development activities align with applicable FDA, EMA, ICH, and other relevant regulatory guidance.
• Collaborate closely with Clinical, Regulatory, Pharmacology, DMPK, and other functional teams to support programs from discovery through clinical development.
• Manage external CROs, consultants, and toxicology studies, ensuring scientific quality, appropriate timelines, and regulatory compliance.
• Present toxicology findings, risk assessments, and development recommendations to senior leadership and key stakeholders.

• PhD, DVM, or equivalent advanced degree in Toxicology, Pharmacology, or a closely related scientific discipline.
• Current board certification in toxicology, such as Diplomate of the American Board of Toxicology (DABT), or an equivalent recognized credential.
• At least 5 years of relevant professional toxicology experience within the pharmaceutical industry or a relevant regulatory agency.
• Demonstrated ability to design toxicology studies in accordance with regulatory expectations and critically evaluate findings across acute, subchronic, chronic, reproductive and developmental, genotoxicity, carcinogenicity, and other relevant endpoints.
• Strong ability to integrate animal, human, in vitro, in silico, exposure, and mechanistic data into scientifically defensible conclusions.
• Proven expertise in toxicological risk assessment, including hazard identification, dose-response assessment, exposure assessment, and human health risk characterization.
• Strong understanding of toxicology regulations, standards, and guidance issued by agencies such as FDA, EMA, and other relevant regulatory authorities.
• Strong scientific judgment and analytical skills, with the ability to translate complex safety data into clear development recommendations.
• Excellent communication and presentation skills, with the ability to effectively engage senior leadership and multidisciplinary stakeholders.
• Strong collaboration and project management capabilities, including experience working with external CROs, consultants, and cross-functional teams.

• Remote consulting opportunity based in India.
• Opportunity to provide strategic scientific leadership for oncology drug development programs.
• High-impact work spanning discovery, nonclinical development, clinical progression, and regulatory activities.
• Exposure to complex toxicology and safety assessment challenges across multiple scientific disciplines.
• Opportunity to collaborate with Clinical, Regulatory, Pharmacology, DMPK, and other specialized teams.
• Significant influence over nonclinical strategy, risk assessment, and development decision-making.
• Opportunity to contribute to regulatory submissions and interactions with major health authorities.
• Flexible consulting environment with the potential to work remotely.