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Associate Director/Director (Non-Clinical Pharmacology & Toxicology)

AlphaGen

AlphaGen

Beijing, China · Shanghai, China
Posted on Monday, November 27, 2023

This role will play a pivotal role in non-clinical related process and activities, from candidate identification and selection to IND regulatory submission and support further development of the assets. This role will manage preclinical studies, dossier preparation, encompassing toxicology, pharmacology, pharmacokinetics, bioanalytical sciences, and regulatory related non-clinical activities.

Key Responsibilities:

  • Manage and conduct pharmacology, toxicology, pharmacokinetics, and bioanalytical studies, ensuring compliance with regulatory standards;
  • Collaborate with cross-functional teams to integrate preclinical data into clinical development plans and regulatory submissions;
  • Oversee the drafting and submission of regulatory documentation;
  • Manage relationships with external partners, including CROs as well as internal function teams such as CMC teams to ensure effective collaborations.

Qualifications:

  • PhD in Pharmacology, Toxicology, or related field, extensive experience of small molecule, peptide or ADC discovery in oncology;
  • A minimum of 7 years of preclinical research roles, experience within the radio pharmaceutical industry is a plus;
  • Proven track record in managing preclinical studies, regulatory submissions, and dossier writing for oncology product;
  • Expertise in toxicology, pharmacology, pharmacokinetics, bioanalytical sciences;
  • Strong leadership skills, with the ability to manage internal and external partners effectively;
  • Thorough knowledge of global regulatory guidelines and compliance standards.

How to Apply:

Together, we can bring breakthrough treatments to patients globally.

We are looking for highly qualified and motivated individuals who are excited to bring life-improving medicines to cancer patients.

At AlphaGen, we aim to navigate a host of multidisciplinary challenges—discover and develop compelling R&D programs; work closely with local and global partners to bring technologies into China and around the world; and bring a new class of life-changing therapies to an untapped market.

If you are a strategic thinker with a passion for radiopharmaceuticals and a desire to make a meaningful impact on healthcare, we encourage you to apply. Please submit your resume and cover letter to vivian.peng@alphagentx.com with the subject line "[Your desired position] Application - [Your Name].

AlphaGen is an equal opportunity employer.

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