Job DescriptionMy client is a clinical stage biopharma company developing novel CNS therapeutic products.
Roles and Responsibilities
- Develop and lead Discovery and Preclinical Research strategies for lead and pipeline programs.
- Manage daily activities, team, and budget, ensuring contingency plans are in place.
- Produce pharmacology data to standards and create development hypotheses in CNS therapeutic areas.
- Coordinate with third parties (CROs, partners, academic centres) to achieve strategic goals.
- Oversee preclinical regulatory submissions and interactions with agencies (FDA, MHRA, EMA, TGA, etc.).
- Collaborate with Clinical Development and Chief Medical Officer on trial designs and protocols.
- Partner with Intellectual Property team to identify and secure IP from research activities.
- Ensure studies adhere to SOPs and regulatory guidelines.
- Design nonclinical programs in compliance with ICH requirements for smooth phase transitions.
- Maintain Preclinical GxP and Health & Safety standards through ongoing training.
Experience, Skills, and Qualifications
- Degree in Pharmacology or related field; PhD preferred.
- Extensive senior-level experience in Pharmacology and Preclinical research within the pharmaceutical industry.
- Knowledge of preclinical drug development legislation and guidelines.
- Experience in scientific technical writing for regulatory documents and publications.
- Proven presentation skills at national and international forums.
- Strong budget management and organizational skills.
- Effective problem-solving and time management abilities.
- Leadership experience in team management and development.
- Excellent written and verbal communication skills.
- Proficiency in Excel, Word, PowerPoint, EndNote, literature search engines, and scientific software (e.g., GraphPad).