The Senior Director, Clinical & Regulatory Development as a leader and leading subject matter expert in metabolism focused clinical and regulatory development processes, will be responsible for the direct managerial and functional oversight of the clinical and regulatory development division (CRD) at ProSciento. The SD, CRD will lead and further develop the division based on existing and future business processes and their respective key quality indicators (KQIs) and key performance indicators (KPIs). In collaboration with the executive team and business development (BD) team the SD, CRD will contribute to the future development of ProSciento’s CRD services portfolio, and will be responsible for the organization, processes, and quality of the CRD division. The SD, CRD will be responsible for the management of ProSciento’s CRD services providers, including internal resources, external CRD vendors, business partners, and consultants. The SD, CRD interacts closely with the business development department and the CRU and CRO divisions and will manage established relationships with clients to support their clinical development programs. The SD, CRD will be responsible for adequately positioning ProSciento’s CRD capabilities in the market place, winning new clients and projects for the CRD division in alignment with ProSciento’s sales and strategic goals.
Essential Duties and Responsibilities include the following.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
PhD or MD degree with extensive (15+ years) scientific, clinical drug development, and regulatory experience in the areas of endocrinology, metabolic research, or diabetes.
Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
To perform this job successfully, an individual should have excellent computer skills with intermediate to advanced knowledge in the current Microsoft Office Suite. Must have electronic document management experience. Ability to quickly learn and use new software systems.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is occasionally exposed to work near moving mechanical parts; work in high, precarious places and fumes or airborne particles. The noise level in the work environment is usually quiet to moderate.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception, and ability to adjust focus. While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee is frequently required to stand; use hands to finger, handle, or feel and reach with hands and arms. The employee is occasionally required to walk and stoop, kneel, crouch, or crawl.