Associate Director, 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. We currently have 9 products in the market that are making a real impact on patient outcomes.

Job Summary:

The Associate Director, Clinical Development is a strategic clinical leader responsible for the design, execution, monitoring, interpretation, and communication of clinical research supporting marketed and investigational products. The role serves as the clinical lead for assigned studies and contributes clinical expertise and strategic insight to asset-level development planning across the product lifecycle.

Essential Duties & Responsibilities:

Clinical Development Strategy

• Contributes to the development and execution of Clinical Development Plans (CDPs) for marketed and pipeline products.
• Lead the design, authoring, review, and implementation of clinical protocols and protocol amendments.
• Develop and communicate study-level benefit-risk assessments and contribute to broader program-level benefit-risk evaluations supporting development decisions.
• Evaluate emerging scientific, clinical, competitive, and regulatory trends and assess implications for development programs.
• Contribute clinical expertise to due diligence activities, asset evaluations, licensing opportunities, and lifecycle management assessments, as appropriate.
• Contribute to the assessment of safety, efficacy, unmet need, differentiation, regulatory considerations, and commercial value propositions supporting development decisions.

Clinical Leadership and Medical Monitoring

• Serve as study-level clinical lead for assigned studies.
• Conduct ongoing review and interpretation of safety data, protocol deviations, eligibility assessments, and study conduct.
• Support safety signal evaluation in partnership with Pharmacovigilance.
• Participate in DMC, DSMB, and safety review activities.
• Translate clinical findings into actionable development recommendations and strategic insights.

Study Execution and Operational Excellence

• Partner with Clinical Operations on feasibility, enrollment, retention, and site engagement strategies.
• Oversee CROs, vendors, and consultants supporting assigned studies.
• Ensure compliance with protocol requirements, ICH-GCP, and applicable regulations.
• Identify operational risks and support mitigation strategies to ensure successful study execution.

Cross-Functional Leadership

• Represent Clinical Development on Study Teams, Asset Teams, and governance forums.
• Partners with Clinical Operations, Regulatory Affairs, Biostatistics, Pharmacovigilance, Medical Affairs, Commercial, and external stakeholders to support evidence generation, clinical development planning, benefit-risk evaluations, and development decision-making.
• Prepare decision-focused presentations and recommendations for leadership review.
• Translate complex clinical, safety, and scientific information into concise, decision-oriented recommendations tailored to diverse stakeholder audiences.

Scientific Communications

• Lead or co-lead Clinical Study Reports (CSRs), publications, scientific presentations, and regulatory documents.
• Maintain productive relationships with investigators, key opinion leaders, and external experts.
• Contribute to scientific advisory boards, investigator meetings, and external scientific engagements as appropriate.

Scope of Influence and Decision Making

• Owns: Study-level clinical oversight and scientific recommendations; Clinical leadership for assigned studies; Interpretation and communication of emerging clinical data.
• Influences: Clinical Development Plans (CDPs); Benefit-risk evaluations; Evidence generation strategies; Regulatory planning activities; Governance discussions and development recommendations.
• Escalates: Significant safety, regulatory, operational, and strategic risks requiring leadership review and decision-making.

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:

• M.D. Preferred with 6+ years' experience in Clinical Development, Clinical Science or Medical Affairs.
• PharmD or PhD in scientific discipline or equivalent degree considered with a minimum of 5+ years of relevant experience in Clinical Development, Clinical Science or Medical Affairs.
• Typically, 5-8+ years of experience in Clinical Development, Clinical Science, Medical Affairs, or related drug development functions.
• Experience with protocol development, medical monitoring, clinical data review, CSR authorship, and CRO oversight.
• Experience supporting Phase 1-3 clinical development programs preferred.
• Working knowledge of FDA, EMA, and ICH-GCP requirements.
• Strong understanding of clinical trial design, clinical data interpretation, evidence generation, and benefit-risk assessment.

Leadership Competencies

• Strategic thinking and business acumen.
• Scientific and clinical judgment.
• Benefit-risk assessment and decision-making.
• Executive communication and influence.
• Cross-functional leadership.
• Problem solving and critical thinking.
• Learning agility and adaptability.
• Leadership without authority.
• Collaboration and stakeholder management.

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 $164,000 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 employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, national origin, disability, protected veteran status, age or any other characteristic protected by law.