Acerand Therapeutics Ltd (China), located in Shanghai, China, is a start-up pharmaceutical company focusing on Cancer and Autoimmune disease drug discovery research. If you have interest in this position and are determined to make life better for people, please send your CV and contact information to email@example.com
Major Responsibilities including but not limited to:
- Design and oversee theconduct of both GLP toxicology and non-GLP studies to support our platform and therapeutic programs.
- Serve as a Study Monitor for outsourced toxicology studies. Responsibilities include protocol development, successful execution and report review, ensuring that the studies are conducted in line and adhere to appropriate guidelines and regulatory testing standards.
- Leadthe identification, evaluation, selection and management of Contract Research Organizations (CROs) to ensure successful execution of studies in a timely manner.
- Collaborate on the design of internal non-GLP investigative toxicity studies in support of advancement of the platform and development compounds, as needed
- Analyze and interpret toxicology/safety pharmacology data and provide recommendations to the platform/program teams.
- Contribute to the preparation of nonclinical components for regulatory submissions
Education and Experience Requirements:
- Master or doctor degree in Toxicology, Pharmacology or closely-related discipline.
- Minimum of 10 years of experience advancing drug discovery projects into development within a biopharma environment.
- Experience in oncology product development is a requirement.
- Outstanding organizational and interpersonal skills, and outstanding ability to manage relationships and influence others.
- Proven experience in designing GLP and non GLP safety studies.
- Demonstrated ability to work closely with CROs and provide close oversight of vendors, budget planning and coordination.
- Hands on experience in relevant laboratory techniques.
- Willingness to be both a strategic leader and hands-on problem solver.
- Experience allocating resources and managing budgets.
- Proven knowledge of FDA/NMPA regulations.
- Superior oral and written communication skills are required, and the ability to work effectively with senior management. Strong analytical and scientific writing skills. At least basic level of English listening and writing skills
- Strong creativity, independent thinking and results orientation is required.
- Must have high ethical standards and impeccable integrity.
- Strong people leadership abilities, including inspiring and motivating a high performing team, setting clear direction, enabling cross-functional collaboration, empowering people, and developing and coaching talent.