Senior Director, Clinical Development
1 month ago
Job Summary: The Senior Director, Clinical Development is a key leadership position at Supernus Pharmaceuticals, Inc. The successful candidate will report to the Vice President of Clinical Development. The candidate is expected to lead clinical development activities in support of key initiatives: (1) design and support the clinical development plans and regulatory filing of pipeline products; (2) support clinical research of post marketing of current marketed products; (3) support evaluation of future research opportunities; (4) collaborate with medical affairs, clinical operations, biometrics, portfolio, and regulatory on clinical development activities.
Individual will work with clinical development team and will be responsible for preparation of clinical documentation in support of Phase 1-4 clinical studies. The individual will be responsible for the clinical development plans and all the clinical regulatory documents. Experience in neurology is desired. This job summary is not inclusive. Please note that this position is remote.
Essential Duties & Responsibilities:
* Design, implementation, and execution of clinical protocols (phase 1-4), internal strategy and planning documents, final reports, and peer-reviewed publications with commercial, statistical, and operational input
* Previous proven experience in IND and NDA submissions and interaction with health authorities
* Co-monitor clinical activities with 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, and commercial teams.
* Monitor and interpret results of clinical investigations in preparation for potential publications, commercial partnerships and / or regulatory findings.
* Work with Biometrics team to develop Statistical Analysis Plan and to create post-hoc analyses.
* 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 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.
* Other Duties as Assigned.
Supervisory Responsibilities:
* Provides leadership and management in an effective manner consistent with Company Values towards defined Corporate Objectives as applicable.
* Understands Company Policy and procedure to be able to follow and guide direct reports appropriately, if applicable.
Knowledge & Other Qualifications:
* D. Preferred with 5+ years' experience in Clinical Development
* D. or Ph.D. in a scientific discipline or equivalent and a minimum of 9+ years of relevant experience with 7+ years in Clinical Development.
* 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.
* Skilled in scientific and clinical research writing.
* Ability to use the Microsoft Office Suite effectively including Word, Excel, and PowerPoint.
* Ability to clearly communicate clinical and scientific benefits and risks 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 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.
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.
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