Executive Director, Clinical Development (Possibly REMOTE)
To provide leadership to the Clinical Development group covering medical and scientific as well as operational aspects of clinical development. Provide clinical expertise to the strategic development of clinical development plans and supervise all aspects of Phases I-IV Clinical studies including design, execution and reporting; work in partnership with all other relevant development functions during the overall development of new medicines and act as a liaison with Business Development by providing clinical expertise and strategic input and participate in internal and external meetings as requested.
Plan, direct and interpret clinical studies and products (pharmacology, toxicology, and drug metabolism), and clinical trials, and methods of data collection. Facilitate and support the development of products through the various stages of clinical research and development; collaborate with all disciplines within the Company. Establish and approve scientific methods for design and implementation of clinical protocols, data collection and final reports.
- Design clinical development strategies for product candidates following the 505(b)(2), 505(j), and 505(b)(1) regulatory paradigms.
- Design of individual clinical trials and writing/review of protocols and other critical study documents, including Investigator Brochures, IND submissions, Clinical Study Reports, and relevant parts of NDA submissions.
- Identify and evaluate complex clinical problems where analysis of situations or data requires an in-depth evaluation of various factors.
- Interact internally and externally with executive level management requiring negotiation to influence policy-making bodies and to facilitate clinical trial research and scientific studies.
- Establish and approve scientific methods for design and implementation of clinical protocols, data collection systems, and final reports. Monitor adherence to protocols and SOPs.
- Manage and coordinate the activities of the Clinical Development Department. Mentor, develop and manage appropriate staff, who perform functional responsibilities.
- Develop systems for organizing data to analyze, identify and report data and trends.
- Responsible for reviewing and approving clinical reports, data summaries from clinical studies for submissions to the FDA, or other regulatory agencies, and for publication and /or presentation. Develop formats and guidelines for clinical documentation.
- Maintain current knowledge of professional information and technology. Determine appropriate actions and direct staff.
- Review timelines for tracking study progress and present to project teams and/or upper management.
- Collaborate with all relevant product development functions and the business development department to provide clinical and strategic input.
- Facilitate discussions with KOLs.
- PHASES I THROUGH PHASE IV Studies
Design and implement appropriate Phases I-IV clinical studies to support all Noven sponsored clinical trials.
Represent our Team and seek input from key customer groups.
Stay abreast of current trends and medical practice in the therapeutic areas related to Noven’s interests. This includes intelligence on essential and critical new technologies or treatment advances. This person will make a presentation to the President and the Board of Directors.
Competencies Judgment / Decision Making:
Under general direction with periodic review of assignments. Complex work performed within a framework of functional policies and procedures requiring high degree of original thinking.
Education & Experience:
M.D. or Ph.D. in related field or equivalent. At least ten (10) years professional experience in pharmaceutical industry, clinical/medical research, or nursing; involvement in transdermal delivery systems preferred. Experience in working on / leading interdisciplinary product development teams. Knowledge of FDA regulatory requirements and internal SOPs. Previous management or supervisory responsibilities. Computer literate with intermediate knowledge of office application software. Excellent written and verbal communication skills.