Skingenix, Inc. is committed to equal employment opportunity in its business operations and employment practices. The Company strives to comply with all applicable laws prohibiting discrimination against any applicant or employee on grounds of race, ancestry, place of origin, color, ethnic origin, citizenship, age, creed, sex, marital status, family status, handicap, record of offenses, and sexual orientation.
Skingenix, Inc., is a Southern California based start up company specializing in regenerative medical and health product development. As an innovative and mission-driven company, Skingenix pursues to establish a standard of excellence for regenerative medical industry with an emphasis on developing organ in situ regenerative products for improving human health and quality of life.
Open Position :
Senior Manager/Manager Clinical Operations
Skingenix, Inc -Job Location: Ontario, CA
Skingenix, Inc has an immediate need to hire a Senior Manager/Manager Clinical Operations. Skingenix, Inc, a leader in dermal regeneration technologies is located in Ontario, California. As an innovative and mission-driven company, Skingenix pursues a standard of excellence in the regenerative medical industry with an emphasis on developing organ in situ regenerative products for improving human health and quality of life
Desired Skills and Experience
The Senior Manager/Manager Clinical Operations will play a key role in the IND lifecycle management phase, managing clinical trials in burns, diabetic foot ulcers and other indications. As a key employee, the candidate will enjoy the opportunity to be involved in every aspect of the drug product development process and will contribute to the company’s worldwide business development adventures.
This key role will manage all aspects of clinical trials (Phase II-III), plan, and execute clinical studies, including creating and managing study timelines, budgets, and project management plans in a fully out-sourced model. Additionally, s/he will provide guidance and shared learning across teams throughout planning and implementation, as well as ensure clinical operational and development deliverables and timelines are met across the development program(s). This position will report to the Senior Director, Clinical Development and will be responsible to train key clinical operations staff.
Essential Duties and Responsibilities:
- Lead the evaluation, selection and management of Contract Research Organizations (CROs) and other external vendors to ensure successful clinical trial implementation and execution
- Create, manage, and execute all aspects of clinical operations programs, including but not limited to study management, budget and Gantt timeline creation in MS Project
- Liaise with clinical site staff and Investigators to ensure optimal Sponsor-site relationships
- Draft/Review study protocols, ICFs and other relevant clinical documents as necessary
- Manage all aspects of study progress from planning to close-out to ensure timeline adherence and achievement of study goals while ensuring quality and data integrity in accordance with FDA, GCP, and ICH guidelines
- Lead, plan, and execute clinical Investigator meetings, study meetings and vendor meetings
- Contribute to Clinical Operations initiatives/programs including identifying areas of best practices and recommend process improvements, development of SOPs, risk management planning etc.
- Contribute in drafting documents for regulatory filings for INDs, NDAs; study reports, annual reports, and other documents for submission to relevant regulatory agencies as needed
Experience, Education and Specialized Knowledge and Skills
- BS in a scientific or relevant healthcare discipline required; MS or Advanced degree preferred
- 8+ years clinical drug development experience or a combination of education and relevant work experience in the pharmaceutical/biotech industry; Understanding of drug development from pre-IND through NDA required; Demonstrated knowledge of FDA regulations and ICH/GCP guidelines required; Experience monitoring clinical studies and conducting PSVs, SIVs, IMVs, and COVs; Experience in supervision and training of clinical operations staff and team leaders
- Excellent oral, written communication skills required; lead in a collaborative team environment