Position Title: Director, Clinical Affairs
Department: Clinical Operations
Reports to: VP, Regulatory - Clinical - Quality
We are seeking an outstanding professional for the position of Director, Clinical Affairs. The successful candidate will report to the Vice President, Regulatory, Clinical and Quality, as well as work in close collaboration with others in the Regulatory, Clinical R&D, Engineering and Operations. The successful candidate will have an opportunity to leverage their tenacity, professional skills and capabilities and reap the rewards associated with Company's commercial success.
This position is responsible for the overall management of clinical trials including, but not limited to, the developing trial protocol and statistical plan, establishing and maintaining the relationship with clinical sites, and managing the clinical operation study from the ramp-up phase, through enrollment team and study conclusion, including report. This position works with internal staff members (e.g. data management, publications) and external consultants to ensure the conduct of clinical trials at Company comply with regulatory requirements.
MAJOR DUTIES AND RESPONSIBILITIES
: Responsible for the execution and implementation of clinical activities that will support both current and future US and international studies, regulatory filings and approvals, marketing objectives and other goals of the Company (in alignment with the Company's overall goals).
: Develop and execute of the clinical trial strategy, including successful recruitment of patients, effective communication of strategy and implementation plans to clinical team.
: Develop study protocol, case report forms, data management, and procedures required in all aspects of conducting clinical trials.
: Manage clinical trial budget and ensures timelines are being driven in accordance with the goals and objectives of the Company.
: Provide leadership and oversight of clinical operation teams, internal and external (CRO), to ensure GXP compliance and adherence to Quality systems.
: Responsible for developing, monitoring and reporting metrics designed to improve and assess trial performance, including speed and effectiveness of site start-up, training, speed and accuracy of screening, recruitment, protocol adherence, data collection and reporting.
: Facilitates the negotiation and administration of contracts, investigators and other organizations involved in clinical studies.
: Manages cross-functional efforts among internal departments to ensure clinical and pre-clinical data is collected to withstand regulatory investigations.
: Manages vendor relationships to facilitate effective communication and efficient interactions with them to optimize clinical trial performance.
: Ensures that all clinical site and field personnel are reporting adverse events and apply proper clinical procedures to assist investigators in resolving adverse events.
: Prepares reports and documents as need to accurately represent clinical study results.
: Assists in regulatory affairs sign-off and approvals of ECO's during the development process.
: Assists as needed in the resolution of customer complaints and maintaining client satisfaction.
: Develops an efficient and organized system for updating management and staff on clinical study progress.
Education and/or Job Experience:
: BS in Life Sciences, advanced degree is preferred.
: Minimal 10 years of experience in life science or medical devices industry.
: In-depth working knowledge and track-record designing and executing clinical trials.
: In-depth understandings of CE mark guidelines and FDA guidelines for Clinical Studies.
Special Skills, Abilities, and Requirements:
: Must have strong working knowledge of clinical research and familiar with requirements of regulatory agencies.
: Experience in infertility technology a plus, but not required.
: Must have strong communication, interpersonal skills and attention to detail.
: Experience in the management of a fast-paced, multi-center clinical trial.
: Highly motivated with excellent work ethics.
: Proficient in computer skills (Microsoft Office products, word processing, excel, etc.).
: Background in women's health is strongly preferred.
: Must be able to travel 25% - 40% of the time (USA and International).