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. We currently have 8 products in the market that are making a real impact on patient outcomes.
Job Summary: To perform duties essential for preclinical candidate evaluation including but not limited to serving on project teams, providing scientific leadership, preparing relevant sections of regulatory dossiers and, interacting with internal and external stake holders including regulatory agencies.
Essential Duties & Responsibilities:
- Provide scientific leadership and insight to cross functional project teams as a valuable member of the R&D organization
- Plays key role in design, implementation, oversight and analysis of nonclinical studies/data to support development of new candidate drugs
- Authors and reviews regulatory documents to support regulatory filings
- Manages multiple projects simultaneously with minimal supervision
- Lead and/or manage both in-house and CRO activities related to nonclinical aspects of drug discovery and development
- Actively supports the integration of early nonclinical safety strategies throughout research
- Solves moderately complex problems requiring thorough scientific assessment
- Work closely in collaboration with supervisor - to meet corporate goals and objectives and be adaptable in a changing environment; bring-in new collaborative/business proposals to strengthen Supernus pipeline
- Other duties as assigned
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, if applicable.
Knowledge & Other Qualifications:
- Graduate degree (PhD or equivalent) in toxicology or related life-sciences or DVM
- Minimum of 6+ years of relevant experience
- Experience working in the Pharmaceutical Industry highly preferred
- Prior participation in IND/NDA filing is desirable
- Able to independently guide and manage multiple non-clinical programs in development
- Able to independently interact with CROs, obtain proposals, finalize contracts, initiate studies and finalize quality reports
- Able to maintain good relationship with vendors and resolve toxicity issues, if any, collaboratively
- Must be able to clearly articulate project needs and status to project team and Supernus management
- Knowledgeable in Good Laboratory Practices, International Conference on Harmonization guidelines and interfacing with global regulatory agencies, as necessary
- Board certification in Toxicology (e.g. DABT) or related disciplines (e.g. DACVP) is desirable
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 $158,000 to $190,000. 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.
Base salary is one part of the overall compensation package, which includes the opportunity to participate in employee stock purchase programs and performance-based bonus programs.
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.