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 including preclinical 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 to include design, logistics, resource allocation, schedules, identified critical support needs, and other necessary details others to implement 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.
PhD in a relevant discipline and minimum 12 years of progressively responsible, relevant experience in in pre-clinical drug development..
- Deep scientific understanding of potential novel disease approaches for central nervous system disorders
- Advanced understanding of the drug development process and the principles, concepts, practices, and standards of pharmaceutical project management.
- Experience in Translational Medicine activities with an emphasis on preclinical pharmacology, safety, toxicology and ADME
- Knowledgeable in the tools and procedures of 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. Through a complete understanding of the tools and design methods, able to evaluate the advantages and disadvantages of each, in terms of applicability to the particular research at hand.
- 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