AavantiBio is seeking a Senior Director of Toxicology, who is an experienced and innovative Toxicologist that has demonstrated ability in drug development to work across a highly matrixed environment to advance translational efforts. The Senior Director of Toxicology will be a key driver for translating discovery research into the clinic, including exploratory, pilot, and pivotal toxicology studies. This leader will be responsible for the overall conduct of the studies and needs to be an expert on the study process and special needs for cell and gene therapy products. The candidate will be expected to work closely and collaboratively with project teams to develop Toxicology strategies for advancement to the clinic. The role reports to the Chief Medical Officer and provides strategic input to Senior Leadership to align and advance business goals and milestones.
· Full-time salary position with the opportunity for annual bonuses and participation in the Equity Incentive Plan. Benefits include high-quality health insurance plans including both gold and platinum Blue Cross Blue Shield plans, for which AavantiBio pays a competitive 85% of the health insurance premiums for our employees and their families. In addition to health insurance, we have put in place flexible spending accounts and other benefits for our employees, including dental, vision, short- and long-term disability, group life insurance, AFLAC, and more. To assist our employees with their retirement planning, AavantiBio offers a safe-harbor 401(k) plan with a generous 6% company match.
Responsibilities – Including but not limited to:
· Design, implement, drive, and oversee toxicology strategies.
· Collaborate with internal teams and external partners to execute on development program objectives.
· Contribute to development program strategy, study execution, data review/analysis, study reports, protocol preparation, and regulatory document preparation; write and review non-clinical toxicology summary documents.
· Oversee vendors and consultants, as appropriate to execute on toxicology studies.
· Report findings and advise the leadership team on preclinical safety of development candidates.
· Lead the resolution of toxicology-related queries from drug regulatory agencies, writing and reviewing responses to regulatory on toxicology-related queries.
· Lead authorship for toxicology sections for all regulatory documents.
Qualifications – Experience, Knowledge & Skills:
· Bachelors, Masters or Ph.D. in Toxicology, Pharmaceutical Sciences, DVM, or a related field is preferred. Extensive related professional experience may be substituted for a terminal degree.
· DABT certification is highly desired.
· 10+ years’ experience in the life science industry in a Toxicology role and proven track record of conducting drug safety assessment studies, and the ability to make sound risk assessments and represent toxicology perspectives on project teams and with external partners.
· 3+ years’ experience developing the toxicology strategy and data package supporting the clinical development of protein biologics.
· Track record of toxicology leadership on multiple development programs at early and late stages of development.
· In-depth understanding of pharmacokinetics and modeling human dosing.
· Experience with EMA and FDA CTA/IND and BLA submissions and regulatory interactions.
· Experience partnering with DMPK, Regulatory Affairs, Clinical, CMC, and Translational Science colleagues to ensure comprehensive Toxicology approaches are developed as part of the program strategy.
· Extensive experience working with strategic outsourcing and study coordination.
· Ability to perform in fast-paced, dynamic, constantly evolving environment.
· Excellent communication and organizational skills and attention to detail.
· Strong time management skills; ability to prioritize multiple tasks efficiently.
The exact level of the job will be determined by the applicant's qualifications and experience. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
EQUAL OPPORTUNITY EMPLOYER
AavantiBio is committed to nondiscrimination with respect to race, creed, color, religion, age, disability, sex, sexual orientation, gender identity and expression, marital status, national origin, political opinions or affiliations, genetic information, and veteran status in all aspects of employment including recruitment, hiring, promotions, transfers, discipline, terminations, wage and salary administration, benefits, and training.
About the company
11-50 employees - Biotechnology
AavantiBio is a clinical-stage biopharmaceutical company committed to developing and commercializing novel gene transfer and gene editing therapies for the treatment of rare and ultra-rare genetic diseases. The company is rapidly building a diverse portfolio of gene transfer and gene editing therapies to target debilitating genetic diseases for which the unmet medical need is high and for which there are typically no approved therapies treating the underlying disease.
AavantiBio is headquartered in Cambridge, MA with an additional location in Gainesville, FL. We are looking for exceptional individuals who share our passion for developing novel therapies to treat rare diseases and advancing the field of gene transfer therapy.
Developing genetic treatments for rare diseases is inspiring but challenging work and it takes dedication and courage which will make a meaningful impact on those who suffer from rare diseases. At AavantiBio, we will push each other to perform at our very best and build a company that not only our employees are proud of, but also the rare disease community, because everyone knows we are trying to make a difference in patients’ lives.
Come join our team!