Manager, Nonclinical Pharmacology/Toxicology - Usona Institute

JOB OBJECTIVE: We are seeking an experienced Manager to lead our Nonclinical Pharmacology/Toxicology team. This role is crucial for overseeing the strategic direction, planning, and execution of pharmacology and toxicology studies to support the development of innovative drug products. The successful candidate will work closely with cross-functional teams to ensure that all nonclinical development activities are conducted in compliance with regulatory guidelines and support product development from discovery through to clinical stages.

CORE DUTIES:

1. Develop and implement nonclinical pharmacology and toxicology strategies for drug development programs.

2. Review and evaluate pharmacology and toxicology data, ensuring rigorous assessment of safety and efficacy.

3. Collaborate with regulatory agencies to align nonclinical study designs with regulatory requirements.

4. Lead interactions with external partners, including CROs and academic institutions, to execute nonclinical studies.

5. Provide expert guidance on nonclinical regulatory submissions, including INDs, Investigator's Brochures, and NDAs.

6. Demonstrates inclusion through their own words and actions and is accountable for a safe workspace. Acts with kindness, curiosity and respect for others.

7. Embracing and being open to incorporating Emotional & Social Intelligence (ESI) core principles in daily work.

8. Understands and complies with ethical, legal and regulatory requirements applicable to our business.

KEY QUALIFICATIONS:

1. Advanced degree (Ph.D., D.V.M., or equivalent) in pharmacology, toxicology, or related biological sciences.

2. A minimum of 5 years experience in nonclinical drug development within the pharmaceutical industry.

3. Extensive experience in nonclinical drug development within the pharmaceutical industry.

4. Proven track record of successful leadership and management in a scientific research setting.

5. Deep understanding of FDA and international regulatory requirements and guidelines (e.g., ICH, EMA) related to nonclinical pharmacology and toxicology.

6. Excellent communication and collaboration skills to effectively interact with internal teams and external stakeholders.

PREFERRED QUALIFICATIONS:

1. Experience in psychedelic drug development.

PHYSICAL DEMANDS:

1. Ability to use computer equipment.

2. Travel may be required.

At Usona, we value diversity and strive to create an inclusive workplace. We are proud to be an Equal Opportunity Employer, making employment decisions without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability, or any other protected class.