Senior Director, Therapeutic Development
Reporting to the CSO, the Sr. Director, Therapeutics Development will support the ATRECA pipeline by providing scientific direction, coordination and program management support for all internal and outsourced Therapeutics Development activities.
This individual will provide leadership for non-clinical development of investigational drugs, by providing:
- Strategic and tactical support for CMC related activities performed by CROs leading to preparation of relevant sections for IND and NDA/BLA regulatory submissions (and ex-US equivalents);
- Planning, design, oversight, analysis, and reporting of non-clinical pharmacology, safety, toxicology and related studies, including GLP studies performed by CROs;
- Timely preparation of non-clinical summary document preparation for regulatory submissions (INDs, NDAs, etc.) and content for relevant clinical documents (Investigator Brochures, protocols, Informed Consent Forms, etc.);
- Guidance to cross-function early drug development teams who facilitate collaboration with clinical teams, in order to develop appropriate early clinical development plans;
- Support for business development opportunities and interactions between the development unit and key academic collaborators involving non-clinical projects;
- Provide appropriate leadership, mentoring, and development as required.
- A minimum of 10 years of highly relevant pharmaceutical/biotechnology industry experience with strong background in non-clinical development.
- MD and / or PhD in relevant technical discipline is required.
- Experience supporting CMC related activities, safety, toxicology and pharmacology activities and global regulatory affairs that includes authoring appropriate sections in IND and ex-US equivalents.
- Experience attending and participating in meetings with health authorities and responding to regulatory authorities’ comments/questions in pre-IND and IND meetings
- Excellent technical writing and communications skills with strong background in biologic therapeutics development and regulatory writing.
- Detail oriented with excellent organizational skills and demonstrated ability to effectively manage geographically distributed resources, vendors and collaborators.
- Excellent computer skills including MS Word, MS PowerPoint, MS Excel, MS Project etc.
- Strong team player with excellent verbal and written communication skills.
- Experience in developing and organizing a budget.
- Ability to accommodate international travel to support all development and regulatory efforts.
Atreca is an equal opportunity employer.