Preclinical Sciences and Innovation (Pharmacology and Toxicolog) Lead Ocugen

5.0 - 7.0 years

8 - 15 Lacs

Hyderabad

Work from Office

Job Purpose Responsible for the design and oversight of safety pharmacology, exploration, and GLP-compliant toxicology studies. Manage multiple projects efficiently across various stages of discovery, preclinical, and clinical development. Contribute to the preparation and review of regulatory submissions and engage with regulatory authorities and cross-functional asset teams This position is located in Hyderabad, Telangana, India. Duties And Responsibilities : Preclinical Pharmacology Design, supervise, and interpret in vivo efficacy studies using a range of disease models. Provide scientific and technical oversight for preclinical pharmacology programs. Prepare study proposals, budgets, and timelines. Lead and mentor scientific staff supporting pharmacology operations. Analyze and compile data, ensuring GxP-compliant documentation and reporting. Contribute to the drafting and revision of regulatory documents including investigator brochures and study reports. Toxicology & Safety Assessment Lead toxicology strategy across discovery, preclinical, and clinical development phases, with an emphasis on human risk assessment and elucidation of toxicity mechanisms for novel therapeutic targets. Act as the primary liaison with CROs, overseeing study conduct and coordinating with technical, veterinary, and scientific personnel. Manage outsourced GLP and non-GLP studies to ensure adherence to protocols, regulatory requirements, safety standards, and SOPs. Integrate expertise in toxicology, pharmacology, ADME, and regulatory guidelines to design robust nonclinical safety assessment strategies. Identify and apply innovative approaches to streamline and accelerate nonclinical development timelines. Critically evaluate study protocols, data sets, and reports to ensure scientific validity and regulatory compliance. Regulatory and Cross-Functional Support Lead or support the preparation of regulatory submissions (e.g., IND, CTA, IB, NDA, BLA). Develop and implement program-specific toxicology plans in collaboration with cross-functional project teams to support compound progression. Represent toxicology and safety pharmacology functions on multidisciplinary project teams. Author and review toxicology reports and regulatory documents; contribute to regulatory submissions and interactions with global health authorities. Represent toxicology function on multidisciplinary teams supporting all stages of drug development. Contributes to the development of high-quality regulatory submissions for global clinical trials and marketing authorizations. Communicate findings and recommendations effectively to project teams and senior leadership. Qualifications and skills : Ph.D. in Toxicology, Pharmacology, or a related field. Strong knowledge of regulatory guidelines (ICH, FDA, EMA) and GxP standards. Minimum 5 years of relevant industry experience in preclinical drug development, or equivalent regulatory experience. Proven experience in designing, managing, and interpreting non-clinical safety and efficacy studies. Demonstrated ability to prepare and review nonclinical sections of regulatory documents like CTA, IND, IB, NDA, BLA, etc. Effective leadership, project management, and cross-functional collaboration skills. Willingness to travel as needed. Strong communications skills and a track record of accomplishment managing client relationships as well as regulatory agencies for USFDA and EMA. Working conditions: This position operates primarily in an office setting and may include 10% of travel. Mandatory onsite presence is required. Physical Requirements: This is a largely sedentary role.

Posted 12 hours ago

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