The Clinical Research Associate Director is a key leadership position at Supernus Pharmaceuticals, Inc. The successful candidate will lead clinical research activities in support of three key initiatives: (1) post marketing research with current marketed products (2) clinical research supporting regulatory filing of pipeline products; (3) evaluation of future research opportunities, as needed.
Essential Duties & Responsibilities
Non-Essential Duties & Responsibilities:
Knowledge & Other Qualifications:
- Design, implementation and execution of clinical protocols, internal strategy and planning documents, final reports and peer-reviewed publications with commercial, statistical and operational input
- Co-monitor clinical and scientific adherence to protocols, ethical and good clinical practices
- Interact with academics, government officials, professional consultants and other external resources, including CROs, to facilitate clinical trials research
- Serve as clinical and scientific consultant to management, other research project teams, business development, commercial teams
- Monitor and interpret results of clinical investigations in preparation for potential commercial partnerships and / or new-drug applications
- Leads or Co-leads (with commercial colleagues) effort in determining and articulating the attributes related to safety, efficacy, unmet medical need, regulatory approval and successful commercialization of ongoing development and pipeline candidates
- Identify and evaluate compounds or technologies as pipeline opportunities
- Monitor changes in the scientific/regulatory/medical environment, which may impact the global drug development process and pharmaceutical marketplace and communicate them appropriately within the organization
- Develop a recruitment strategy (with Clinical Operations Co-Lead) for all trials as needed
- Manage vendors providing recruitment service as needed
- Pharm.D. M.D, or Ph.D. in a scientific discipline or equivalent and 7+ years of relevant experience and 4+ years directly working in Clinical Research
- A high sense of ethics in a results driven environment
- Scientific background with understanding of scientific, clinical and operational aspects of the drug development process
- Skilled in scientific and clinical research writing
- Ability to use the Microsoft Office Suite effectively including Word, Excel and PowerPoint
- Ability to clearly communicate clinical and scientific benefits and risks to team members and management;
- Ability to attain confidence of team and company through personifying professionalism and clinical/scientific knowledge
- Ability to maintain and eventually build appropriate relationships with academics, government officials, professional consultants and other external resources including CROs
- Ability to initiate project efforts in a self-motivated way, including acquiring certain resources (e.g. prospective investigators, publicly available information, etc.)
- Ability to work in a project team and lead or co-lead projects with operational counterpart
- Ability to work independently and as part of a team.
- Capable of being innovative and dynamic in approach to work.
- Authorized to legally work in the United States without visa sponsorship.
- CNS drug development experience is highly desired
Supernus Pharmaceuticals is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, age or any other characteristic protected by law.