Reporting to the Head of Development, the Associate Director/Director of Nonclinical/Preclinical will work closely with the R&D team to develop strategic plans for nonclinical development. The ideal candidate will be responsible for planning and developing nonclinical activities (pharmacology and toxicology) and will provide guidance in nonclinical development to project/program team members. The Associate Director will be highly collaborative, and will adhere to established processes, policies, and quality systems for outsourcing, managing and reporting regulatory toxicology programs, studies, and other activities in support of Rocket’s gene therapy pipeline.
- Design and manage preclinical studies (GLP and non-GLP) for inclusion in regulatory submissions including pharmacology and toxicology
- Oversee and nonclinical studies conducted by CROs and other third parties
- Work closely with cross functional team members to ensure all toxicology and pharmacology studies are completed in a quality, timely, and scientific manner
- Provide guidance to project team members through evaluating the impact of study results on program and clinical/regulatory strategy
- Lead the generating of nonclinical documents for health authority submissions to both FDA and EMA (ie INDs, IMPDs, brochures, briefing documents, nonclinical study reports and nonclinical summaries to support regulatory submissions)
Education & skills
- Minimum MS in Biological Sciences or related field with
- 5+ years of nonclinical development experience in pharmaceutical or biotech company
- Background in viral vector gene therapies, preferably LVV or AAV
- Hands-on experience in all aspects of Toxicology and Pharmacology
- Knowledge of US FDA and European nonclinical regulatory requirements for gene therapy with hands-on experience supporting submissions of such regulatory documents
- Ability to operate in a fast-paced, collaborative environment
- Demonstrate strong verbal, written, and interpersonal communications skills with the ability to explain complex concepts with clarity and simplicity.
Rocket Pharma is bringing hope and relief to patients with undertreated rare diseases through establishing a sustainable, integrated, multi-platform curative gene therapy company. We are searching for hands-on team players that enjoy working in extremely collaborative working environments with colleagues that share an excitement for developing innovative technology to treat unmet medical needs.
Interested in joining our team?
Contact us today!
Resumes with cover letters may be submitted to firstname.lastname@example.org