Join a clinical-stage biotechnology company focused on developing a new call of therapies.
Key Responsibilities
- Oversee the translation of development candidates into viable clinical assets, ensuring that projects progress from preclinical stages through to IND submission
- Establish and implement strategies for preclinical development plans, including pharmacokinetics, pharmacodynamics, toxicology, and manufacturing
- Collaborate with regulatory affairs to ensure that all preclinical development activities align with regulatory requirements for IND submissions
- Foster relationships with key stakeholders, including academic partners, contract research organizations (CROs), and regulatory agencies
- Drive scientific rigor and operational excellence within the translation team
- Provide scientific and strategic input into the company's research priorities and long-term goals
- Lead compliance adherence for all IND enabling activities
Required Qualifications
- PhD or MD with a strong background in biology, pharmacology, or a related field
- Minimum of 10 years of industry experience in drug development, with a proven track record in leading programs from discovery through to IND submission
- Extensive knowledge of the regulatory landscape and experience in preparing IND applications
- Demonstrated leadership in managing multi-disciplinary teams and projects
- Strong strategic thinking, decision-making, and problem-solving skills
