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Responsible for the oversight of Translational Medicine preclinical safety assessment/toxicology deliverables, reporting to the Head of Nonclinical Safety Assessment, with a clear understanding of functional interdependencies and critical path activities. The role will supply the research and/or development of the products, projects, and programs in support of the pipeline. We are looking for someone to conduct and collaborate Cross-functionally on basic research and development including preclinical safety assessment/toxicology studies supporting various projects relevant to the long-term objectives of the company!
- Plans experimental safety assessment/toxicology programs to include design, logistics, prioritization, schedules, identified critical support needs, and other vital details to implement the program(s).
- Provides oversight on scientific management of preclinical safety assessment/toxicology studies supporting early drug development spanning lead optimization through IND and NDA submissions.
- Supervises CROs and leads vendors and consultants to complete Translational Medicine safety assessment/toxicology studies for the various programs.
- Supports due diligence projects by defining nonclinical study plans and compound requirements and developing overall project timelines and associated budgets.
- Works across functional areas on projects including initiating/attending sub-team meetings and coordinating ad hoc working for groups as needed to move project activities forward.
- Communicates project status and issues, and ensures project team goals and regulatory deliverables are met.
- Provides mentorship to team members to objectively assess and resolve project issues to improve project efficiency.
- M.S. or Ph.D. (preferred)in a relevant subject area
- Desired 12 years of dynamically responsible, shown experience supporting drug development.
- In depth understanding of the drug development process and the principles, concepts, practices, and standards of carrying out preclinical safety assessment/toxicology strategies.
- Broad knowledge in the tools and procedures of preclinical safety assessment/toxicology experimentation, including the various experimental designs, statistical tools of data analyses, software applications available for data manipulation and presentation, and instrumentation pertinent to the research.
- Hands-on experience with preclinical study types necessary during drug development, including acute and chronic toxicology, safety pharmacology, developmental and reproductive toxicology, genotoxicity, and carcinogenicity.
- Experience running cross-functional project teams and working in a semi-virtual environment including CROs and academic collaborations.
- Knowledge and understanding of Good Laboratory Practices (GLP), ICH and FDA mentorship, and other relevant regulations and guidelines.
- Confirmed skills and abilities in mentoring, influencing, facilitation, development, and problem-solving.
- Ability to elicit partnership from a wide variety of sources and to be persuasive, encouraging and motivating.
- Ability to learn, understand and apply new technologies, strategies and approaches that improve the team’s ability to achieve goals and meet timelines/deliverables.
- Self-motivation and ability to work with limited supervision.
Establishes strategic plans for preclinical safety assessment/toxicology responsibilities and participates with the Heads of Toxicology and Pharmacology to align objectives across the organization. Develops methods, techniques, and evaluation criteria for projects, programs, and people. Works on complex issues where analysis of situations or data requires an in-depth knowledge of the functional area and related interpersonal objectives. Erroneous decisions will have a serious impact on the overall success of the functional area and may impact the long-term success of the company.
While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment. The employee must occasionally lift and/or move up to 15 pounds. Ability to travel by car or airplane independently up to 25% of the time and work after hours if required by travel schedule or business issues.
What we offer you:
- Competitive base, bonus, new hire and ongoing equity packages
- Medical, dental, and vision insurance
- 401(k) Plan with a fully vested company match 1:1 up to 5%
- Employee Stock Purchase Plan with a 2-year purchase price lock-in
- 15+ vacation days
- 14 paid holidays plus one floating holiday of your choice, including office closure between December 24th and January 1st
- 10 days of paid sick time
- Paid parental leave
- Tuition assistance
Studies have shown that women and people of color are less likely to apply for jobs unless they believe they meet every single one of the qualifications in the exact way they are described in job postings. We are committed to building a diverse, equitable, inclusive, and innovative company and we are looking for the BEST candidate for the job. That candidate may be one who comes from a less traditional background or may meet the qualifications in a different way. We would strongly encourage you to apply – especially if the reason you are the best candidate isn’t exactly as we describe it here.
It is the policy of Acadia to provide equal employment opportunities to all employees and employment applicants without regard to considerations of race, including related to hairstyle, color, religion or religious creed, sexual orientation, gender, gender identity, gender expression, gender transition, country of origin, ancestry, citizenship, age, physical or mental disability, genetic information, legally-protected medical condition or information, marital status, domestic partner status, family care status, military caregiver status, veteran or military status (including reserve status, National Guard status, and military service or obligation), status as a victim of domestic violence, sexual assault or stalking, enrollment in a public assistance program, or any basis protected under federal, state or local law.
As an equal opportunity employer, Acadia is committed to a diverse workforce. If you are a qualified individual with a disability or a disabled veteran, you have the right to request a reasonable accommodation. Furthermore, you may request additional support if you are unable or limited in your ability to use or access Acadia’s career website due to your disability, along with any accommodations throughout the interview process. To request or inquire about your reasonable accommodation, please complete our Reasonable Accommodation Request Form or contact us at [email protected] or 858-261-2923.
Please note that reasonable accommodations granted throughout the recruiting process are not guaranteed to be the same accommodation given if hired. A new request will need to be submitted for any ADA accommodations after starting employment.