Job Summary: To provide leadership, direction, and execution of necessary protocols in the Clinical Operations department.
Essential Duties & Responsibilities:- Partners with Clinical Research and Operations lead to successfully plan and implement clinical trials for assigned programs.
- Oversee vendor selection and management, including request for proposals, day-to-day operations, timeline supervision, study document generation, contract negotiation, budget management, etc.
- Forecasts study budget and actively manage in collaboration with finance department.
- Serves as Clinical Operations Lead in project team meetings.
- Ensures compliance with protocol and applicable regulations/GCPs.
- Contributes to the development of the Target Product Profile for assigned studies.
- Works collaboratively with Clinical Operations and Research leads, and other functional area project team members.
- Leads improvement initiatives in process to ensure best industry standards and approaches.
- Participates in resource planning, including identification of resource options across the assigned programs, and resource analysis across the assigned programs.
- Reviews departmental SOPs that are newly generated or revised and oversees the implementation of finalized SOPs.
Supervisory Responsibilities:- Provides leadership and management in an effective manner consistent with Company Values towards defined Corporate Objectives.
- Understands Company Policy and procedure to be able to guide direct reports appropriately.
Knowledge & Other Qualifications: - Minimum of BS/BA in a biomedical discipline, or equivalent education/training is required.
- BS with 6+ years of experience in related field, or MS with 5+ years of experience in related field, or Doctorate with 3+ years of experience in related field (Ph.D./MD/PharmD/DVM).
- At least 3 years clinical operations and pharmaceutical business experience in order to have a thorough understanding of the processes associated with executing clinical development plans and addressing related regulatory issues.
- Leadership, clinical project management, administrative, and technical capabilities are required.
- Effective verbal and written communication skills.
- Direct experience in clinical pharmacology/experimental medicine research studies/programs preferred.
Other Characteristics:- Ability to work independently and as part of a team and maintain high ethical standards of integrity and quality.
- Ability of having 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 have close visual acuity to perform an activity such as preparing and analyzing data and figures; transcribing; viewing a computer screen, iPad, or other electronic device; and extensive reading.
- The worker is not substantially exposed to adverse environmental conditions.
Compensation:At Supernus, we offer a competitive compensation package that reflects your experiences and contributions. The expected salary range for fully qualified candidates applying for this role is $123,000 to $150,000. This range is what the Company reasonably expects to offer for the position and is not reflective of the full compensation scale of the role. This range may be modified in the future. An individual's salary within the range is based on multiple factors, which may include and are not limited to education, relevant experience, knowledge, length of industry experience and organizational needs.
You also will be able to participate in a competitive benefits package, including but not limited to: health, dental, vision, paid time off, 401k company match, company paid life insurance and health and wellness benefits. The total compensation package for this position also includes other compensation elements such as stock equity awards, employee stock purchase programs and participation in our Company's discretionary annual bonus program.
