Senior Manager, Clinical Development

Supernus Pharmaceuticals is an award-winning biopharmaceutical company with more than 30 years of experience in developing and commercializing products that treat central nervous system (CNS) diseases. At Supernus, we develop innovative products that help treat neurological and psychiatric conditions. At Supernus, we develop innovative products that help treat neurological and psychiatric conditions. We currently have 8 products in the market that are making a real impact on patient outcomes.

Job Summary:  

The Senior Manager Clinical Research is a key position at Supernus Pharmaceuticals, Inc. The successful candidate will lead/co lead clinical research activities in support of three key initiatives: (1) clinical research supporting activities within the Clinical Development Group (phase I – III trials) and regulatory filing of pipeline products (2) post marketing research with current marketed products; (3) evaluation of future research opportunities, as needed. 

Essential Duties & Responsibilities:

• Design, implementation and execution of clinical protocols, internal strategy and planning documents, final reports, and peer-reviewed publications with commercial, regulatory, legal, statistical, and operational inputs. 
• 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 regulatory submissions or 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 new 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 trial recruitment service as needed. 
• Other responsibilities and projects as assigned.

Supervisory Responsibilities:

• N/A.

Knowledge & Other Qualifications:

• Pharm.D. M.D, or Ph.D. in a scientific discipline and 3+ years of experience or M.S. in a scientific discipline or equivalent and 6+ years industry experience.
• 2+ years of Phase 2/3 Clinical Trials Experience is required.
• A high sense of ethics in a result driven environment.
• Scientific background with understanding of scientific, clinical, and operational aspects of the drug development process.
• Ability to clearly communicate clinical and scientific data including assessment of the benefit/risk of assets in development 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.

Other Characteristics:

• Ability to work independently and as part of a team and maintain high ethical standards of integrity and quality.
• Ability to have an innovative and dynamic approach to work.
• A self-starter able to work independently but comfortable working in a team environment.
• Ability to consistently exhibit Supernus Values in interactions with employees at all levels of the organization, vendors, customers, and others.
• Capable of performing other duties as assigned by Management.
• Authorized to legally work in the United States without visa sponsorship.

Physical Requirements/Work Environment/Travel Requirements:

• Sedentary work. Exerting up to 10 pounds of force occasionally and/or carrying objects. Sedentary work involves sitting most of the time.
• The worker is required to hav