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Senior Director, Clinical Development (Neurology)

Supernus Pharmaceuticals
United States, Maryland, Rockville
Nov 15, 2024
Description

Join Our Team as an Epilepsy/Neurology SME in Clinical Development at Supernus Pharmaceuticals!

Are you ready to make a significant impact in the world of pharmaceuticals? Supernus Pharmaceuticals, Inc. is seeking a dynamic and visionary leader in Clinical Development to lead our innovative clinical development initiatives. If you are passionate about CNS treatments, especially epilepsy, and have a proven track record in clinical development, we want to hear from you!

Why Supernus Pharmaceuticals?

At Supernus, we are dedicated to improving the lives of patients through innovative therapies. As a key leader in our Clinical Development team, you will play a pivotal role in shaping the future of our pipeline products and ensuring the success of our marketed therapies. Join us and be part of a collaborative and forward-thinking environment where your expertise will drive meaningful change.

What You'll Do:



  • Lead and Innovate: Design and support clinical development plans and regulatory filings for our cutting-edge pipeline products.
  • Drive Research Excellence: Support clinical research for post-marketing of current products and evaluate future research opportunities.
  • Collaborate and Influence: Work closely with medical affairs, clinical operations, biometrics, portfolio, and regulatory teams to drive clinical development activities.
  • Create Impactful Documentation: Prepare clinical documentation for Phase 1-4 studies, ensuring all regulatory requirements are met.
  • Engage with Experts: Interact with academics, government officials, professional consultants, and CROs to facilitate groundbreaking clinical trials.
  • Consult and Advise: Serve as a clinical and scientific consultant to management, research teams, business development, and commercial teams.
  • Monitor and Interpret: Analyze results of clinical investigations for potential publications, partnerships, and regulatory findings.
  • Strategize and Lead: Develop recruitment strategies for clinical trials and identify new pipeline opportunities.


Supervisory Responsibilities:



  • Lead with Integrity: Provide leadership and management in alignment with Company Values and Corporate Objectives.
  • Guide and Mentor: Understand and guide direct reports on Company Policies and procedures effectively.


What We're Looking For:



  • Experience: Proven experience in IND and NDA submissions and interactions with health authorities.
  • Expertise: Background in neurology (epilepsy) is highly desired.
  • Leadership: Ability to lead and co-lead efforts in determining safety, efficacy, and regulatory approval of development candidates.
  • Adaptability: Stay updated with changes in the scientific, regulatory, and medical environment and communicate them effectively within the organization.
  • Qualifications:


    • M.D. preferred with 5+ years' experience in Clinical Development.
    • Pharm.D. or Ph.D. in a scientific discipline or equivalent with a minimum of 9+ years of relevant experience, including 7+ years in Clinical Development.
    • High ethical standards in a results-driven environment.
    • Strong scientific background with an understanding of the drug development process.
    • Proficiency in scientific and clinical research writing.
    • Effective use of Microsoft Office Suite (Word, Excel, PowerPoint).
    • Clear communication of clinical and scientific benefits and risks.
    • Professionalism and clinical/scientific knowledge to gain team and company confidence.
    • Ability to build and maintain relationships with external resources, including CROs.
    • Self-motivated project initiation and resource acquisition.
    • Teamwork and leadership in project teams.



Why You'll Love Working Here:



  • Innovative Environment: Be part of a company that values creativity and innovation.
  • Collaborative Culture: Work with a team of passionate professionals dedicated to making a difference.
  • Career Growth: Opportunities for professional development and career advancement.
  • Impactful Work: Contribute to the development of therapies that improve patients' lives.


Ready to take the next step in your career?

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.

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 $218,000 to $264,000. 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.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)
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