AmplifyBio is seeking a highly skilled Study Director to join our team of experts in nonclinical research and development. As a key member of our team, you will be responsible for overseeing the scientific aspects of projects, ensuring successful implementation and completion of nonclinical studies.

The ideal candidate will have a strong background in life sciences, excellent communication and project management skills, and the ability to work effectively in a multidisciplinary team. You will be responsible for analyzing and reporting results, providing scientific instruction to team members, and collaborating with senior staff on projects and research.

• Lead nonclinical studies, including toxicology, biodistribution, pharmacokinetic, and related studies.
• Provide nonclinical expertise to cross-functional project teams.
• Partner with business development and project management to generate proposals and costings for new work.
• Work with internal functional areas to ensure all studies are performed in a quality, timely, and scientific manner.
• Draft protocols, amendments, departmental notifications, and study comments forms, ensuring correct grammar, punctuation, consistency in format and style, and adherence to regulatory requirements and contract language.
• Follow GLP and other appropriate regulatory requirements to ensure all experimental data are accurately recorded and verified.
• Author, update, and/or review area-specific SOPs, ensuring that SOPs reflect current practices.
• Manage studies within time and budget constraints.
• Participate in continual improvement initiatives.

• Bachelor's degree in life sciences related field with 5 years of experience or master's degree in related field with 2 years of experience or PhD; or an equivalent combination of education and/or experience in a related field.
• Work within a GLP or similarly regulated environment.
• Excellent communication skills, with attention to detail, with the proven ability to build open and collaborative relationships and work effectively as a member of a multidisciplinary team.
• Excellent time management and organizational skills. Proven ability to handle multiple and changing priorities.
• Experience in the preparation and review of regulatory documents, including writing the nonclinical safety assessment portion of regulatory documents.
• Experience creating and presenting scientific presentations and publications.
• Able and willing to work in a biosafety level 2 (BSL2) environment and wear appropriate PPE.
• Role will require immunization with FDA licensed vaccines and Investigational New Drugs (IND) recommended for persons at risk to occupational exposure of biological agents.

AmplifyBio is a leading contract research organization with a comprehensive range of services that span from being an outsourcing partner for discovery stage R&D work, a preclinical CRO performing safety efficacy and toxicology studies for small molecules and advanced therapies alike, and, most recently, an expansion into manufacturing services for cell, gene, and mRNA-based therapeutics.

We take the health and happiness of our employees seriously and consistently evaluate new ways to Amp up our benefits to provide an amazing place to work. From a wellness program to financial planning and legal assistance, we make sure to take care of our own.

We are an equal opportunity employer and value diversity at our company. We don't discriminate on the basis of race, color, citizenship status, national origin, ancestry, gender (including gender expression and gender identity), sexual orientation, age, weight, religion, creed, physical or mental disability, marital status, veteran status, political affiliation, or any other factor protected by federal, state, or local law.