Job Purpose As part of the Ocugen team, the Preclinical Science and Innovation/Pharmacologist/Toxicologist will involve in planning and monitoring preclinical studies to ensure they are conducted efficiently, accurately, and in compliance with regulatory standards. You will collaborate closely with cross-functional teams to drive study progress, address challenges, and achieve project objectives. The ideal candidate should have expert level experience in drug discovery toxicology. He or she will help direct the design and management of pre-clinical toxicology studies and other safety studies as well as IND enabling activities. We are seeking toxicologists with strong research background in leading toxicology studies who are career-driven, have strong leadership skills, and a depth of experience in working on collaborative research teams. This position is located in Hyderabad, Telangana, India. Duties And Responsibilities: The incumbent is responsible for the liaison and coordination as well as providing scientific support to internal and external partners in terms of international preclinical projects management, including follow-ups. The incumbent also has to ensure that related timelines and budgets are met, activities are properly executed, and adequate resources are allocated. Typical roles and responsibilities for Toxicologist are, Conduct product safety and health risk assessments on the range of products and components through all phases of IND development Work on multi-functional teams and serve as primary toxicology liaison Gather information and provide guidance to project teams regarding all testing standards Provide strategic and hands-on management, ensuring toxicology studies are conducted in line with appropriate regulatory guidelines and standards, these include FDA, WHO, GLP, & ISO Initiate and manage contracts in conjunction with finance group and coordinate activities with academic collaborators for preclinical development in the areas of toxicology, pharmacology, and pharmacokinetics Lead or manage the design, monitoring and interpretation of In Vitro, In Vivo or pre-clinical safety studies conducted under Good Laboratory Practices (GLP) Author or present relevant toxicology information in appropriate journals or at conferences Provide input into safety-related statements and other documentation for use with the public and the media Gather needed information and identify areas of improvement, and provide needed training Participate on cross-departmental teams to contribute to the development or revision of departmental policies and procedures. Key responsibilities: Serves as a recognized toxicology expert and provides scientific and technical leadership to address toxicology issues and support US development programs. Collaborate with HQ to prepare the toxicology part of responses to inquiries from regulatory agencies (Investigator's Brochure, non-clinical assessment sections of INDs, CTAs, and NDAs, etc.). Planning and managing preclinical projects for different programs Act as the project team representative for toxicology on multidisciplinary project teams. Be the interface with toxicology with HQ, health authorities, and the toxicology community to expand our companys local presence and influence in the field. Highly organized individual to manage multiple projects, and work within cross-functional team. Plan and anticipate upcoming difficulties in plan execution, prepare contingency plans and strategies to overcome these difficulties. Qualifications: PhD in toxicology, pharmacology, or a related biological science with 5+ years of experience, or master's degree with 7 years of experience in the biotech/pharmaceutical industry. Understanding of current existing guidelines, regulations, requirements, and standards (GLP, ISO, OECD, ICH, etc). Proven ability to communicate well within a multifunctional drug development team, with excellent oral and written communication skills. The ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks. The ability to proactively develop connections within the organization and with the external scientific community and utilize these resources in the resolution of issues. Experience managing complex pre-clinical studies in accordance with pertinent regulatory requirements. A record of accomplishment managing multiple pre-clinical studies concurrently. Strong project management skills and experience managing complex timelines for clinical studies Experience with clinical and nonclinical programs in biotechnology and pharmaceutical industries Strong analytical skills including interpretation of biologics, vaccines including preclinical and clinical samples Good knowledge of Word, Excel, Power Point, Outlook and Teams; Knowledge of MS Project or Smartsheet considered as an important asset. Strong communications skills and a track record of accomplishment managing client relationships as well as regulatory agencies 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. Direct Reports NA
