For the safety of our employees and communities in response to COVID-19, ACADIA has implemented a temporary work from home policy. As a part of this shift, we have migrated all interviews to virtual interviewing via phone and video.
Responsible for the oversight of Translational Medicine preclinical deliverables with a clear understanding of functional interdependencies and critical path activities. The role will contribute to the research and/or development of the products, projects and program in support of the pipeline. Conducts and collaborates with others on basic research and development focusing on pre-clinical safety, toxicology and DMPK studies supporting various projects relevant to long-term objectives of the company. The role provides study management support for preclinical programs and is accountable for working across functional areas on projects in a timely and cost-effective way. Responsible for the communication of project status and issues, and develops strategies to ensure project team goals and deliverables are met.
- Oversees the management of Translational Medicine deliverables with focus on preclinical development
- Establishes strategies and experimental programs necessary to investigate key lines of scientific inquiry important to the business objectives of the organization, as outlined in the company's strategic business plan and particular department goals
- Plans experimental programs focusing on preclinical safety and toxicology studies to include design, logistics, resource allocation, schedules, identified critical support needs, and other necessary details others to support the program(s)
- Provides oversight on scientific management of preclinical safety, toxicology and DMPK studies supporting early drug development
- Manages vendors and consultants to complete Translational Medicine studies for the various programs
- Provides cross-functional study management support for preclinical programs including development and management of timelines and leading regular team meetings
- Helps support preparation of reports and regulatory documents for IND and NDA submissions
- 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 organizing ad hoc working groups as needed to move project activities forward
- Oversees compilation of Project Team documents associated with all areas of development
- Communicates project status and issues, and ensures project team goals and regulatory deliverables are met
- Proactively anticipates obstacles and devises and implements solutions to achieve project goals through management of relevant team members
- Provides guidance to team members to objectively assess and resolve project issues to improve project effectiveness
The ideal candidate will have a PhD in a relevant discipline, board certification in Toxicology (DABT), and a minimum of 8-12 years of progressively responsible, relevant experience in industrial pre-clinical development.
- Experience in Translational Medicine activities with an emphasis on preclinical development with advanced understanding of preclinical drug safety and toxicology assessments
- Advanced understanding of the drug development process and the principles, concepts, practices, and standards of pharmaceutical project management
- Experience generating and authoring preclinical safety and toxicology reports
- Experience generating and authoring preclinical safety and toxicology regulatory documents including FDA briefing documents, preclinical safety and toxicology summaries, Investigator’s brochures, IND submissions, NDA and sNDA submissions
- Experience managing cross-functional project teams and working in a semi-virtual environment including CROs and academic collaborations.
- Knowledge and understand of Good Laboratory Practices (GLP) and other relevant regulations and guidelines
- Demonstrated skills and abilities in coaching, influencing, facilitation, development, and problem solving
- Excellent communication, presentation, consultative, partnership, and interpersonal skills
- Ability to elicit cooperation 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 enhance the team’s ability to achieve goals and meet timelines/deliverables
- Self-motivation and ability to work with limited supervision
- Skilled at negotiating with business partners or management and influencing senior level leaders regarding matters of significance to the organization
- Proficient at creating and communicating a clear vision among team members effectively aligning resources and activities to achieve functional area and/or organizational goals
Establishes strategic plans for designated function(s) and may participate with others in management 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 functional area and related organizational objectives. Erroneous decisions will have a serious impact on the overall success of 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. 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.
ACADIA is an Equal Employment Opportunity/Affirmative Action Employer: Minority/Female/Disability/Veterans/Sexual Orientation and Gender Identity