Senior Study Director

4 weeks ago

telangana, India Palamur Biosciences Pvt Ltd Full time
Job Summary :
Palamur Biosciences Pvt Limited is seeking an experienced and skilled Senior Study Director Toxicologist to lead and manage the Large Animal Toxicology Department. This role will focus on overseeing toxicology studies using large animal models, including dogs, non-human primates (NHP), swine, and other species. The Senior Study Director will be responsible for study design, execution, regulatory compliance, and the management of toxicology studies, ensuring the highest scientific and ethical standards.
Key Responsibilities :
Lead and manage toxicology studies involving large animal models (dog, NHP, swine, etc.), ensuring that studies are designed, executed, and analyzed effectively.
Develop and oversee protocols for preclinical toxicology studies, ensuring full compliance with GLP (Good Laboratory Practice) and other regulatory guidelines.
Work closely with cross-functional teams to design, implement, and analyze study plans, interpreting results and preparing detailed reports for clients and stakeholders.
Oversee study timelines, resources, and budgets, ensuring that studies are completed within scope, on time, and in line with quality expectations.
Ensure thorough documentation of study findings and results, maintaining compliance with internal and external regulatory bodies.
Serve as the primary contact for clients regarding toxicology studies, offering expert guidance and regular updates.
Manage, mentor, and lead a team of toxicologists, technicians, and support staff, creating a positive and collaborative work environment.
Stay current with industry trends, scientific advancements, and regulatory changes, applying new methods and technologies to improve toxicology study practices.
Manage relationships with external vendors, collaborators, and regulatory authorities to ensure smooth study operations and compliance.
Qualifications :
Education : DAB / MPharm/Msc in Toxicology, Veterinary Medicine, Pharmacology, or a related field,
Experience : Minimum of 8 years of experience in toxicology, specifically with large animal models (e.g., dog, NHP, swine). Prior experience as a Study Director or in a leadership role is preferred.
Skills :
Extensive knowledge of toxicology study design and execution using large animal models.
Proficiency with GLP, regulatory guidelines, and industry standards in preclinical toxicology.
Strong project management skills, with the ability to handle multiple complex studies simultaneously.
Excellent communication skills, both written and verbal, including the ability to write scientific reports and communicate effectively with clients.
Leadership capabilities, with experience managing and mentoring teams of professionals.
Ability to adapt and work in a dynamic, fast-paced environment with a focus on scientific excellence and safety.

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