This position is responsible for the strategy and oversight of the Regulatory Affairs for Clinical Trials. This position will support the expanding pipeline of products in early phase clinical trials from a regulatory perspective. This individual will provide leadership and work closely with other areas within the Institute. This includes the development and implementation of regulatory strategy, ensuring timely preparation for Clinical Trial Design in an IND, review and submission of documents to regulatory authorities, and maintaining compliance with applicable regulatory requirements.
A strong background in the Regulations and Design of Clinical Trials for Regenerative Medicine Products including knowledge and understanding of GMP, GTP, GCP, ICH Guidelines, experience interacting with Regulatory Authorities, and authorship of Regulatory Correspondences is required. The successful candidate will serve as a resource to team members for the regulatory requirements to conduct development activities for regenerative medicine products beginning or advancing in clinical trials and have a minimum of 5 years' experience with FDA in an applicable role. Responsibilities will also include subject matter expertise in regulatory documents to include: INDs (Biologics & Drugs), IDEs and other regulatory submissions and responses, as needed.
In this position the successful candidate will be responsible for driving the development of innovative clinical trials regulatory strategies and the preparation and submission of high-quality clinical sections of INDs in close collaboration with our in-house RMCC Process/Product Development, Manufacturing and Quality Teams, Faculty, and Collaborators.
Leadership regarding clinical research projects, programs, and initiatives. Develop and implement research goals for a clinical trial for a department or institute providing services to multiple faculty.
Provide oversight and guidance on compliance with local, federal and international regulations on clinical trial conduct.
Provide direction to PI's, Clinical Research Managers, funding and resources in order to meet the needs of overall clinical research group.
Clarify and resolve issues with substantial significance and impact, which may span multiple areas, using advanced clinical trials operations and Good Clinical Practice (GCP) knowledge.
Provide direction for the clinical sites to establish protocol development. Review clinical practices, case report forms, and reports.
Serve as a liaison to external organizations/agencies (FDA, NIH, Hospitals). Negotiate and establish external resource contracts.
Provide leadership and coordinate assigned multi-site or large-scale clinical trials research studies conducted by a supervising principal investigator/s in support of actives that meet objectives of assigned research protocol(s).
Access protocols internally, evaluate documentation for feasibility, conduct, and compliance. Provide expertise to improve protocol quality and completeness.
Administer the budget, assign resources accordingly and assist with grant budget proposals related to clinical trials
Ensure clinical trials are conducted according to the approved protocol, GCP, FDA/ JCH guidelines, federal and state regulations and Research standard operating procedures.
Adhere to HIPAA Guidelines and maintain strict confidentiality in the conduct of clinical trials
Protect patient's rights, safety and welfare
Responsible for administration and accountability of investigational product
Provide accurate and detailed documentation per study protocol to ensure data integrity
Other duties as assigned.
Knowledge of hypothesis-generating and experience In hypothesis-testing scientific research projects
Experience with improving quality, implementing metrics, and reporting results for clinical trials.
Proven track record of success across all phases of Clinical trials, proven success record in clinical trial design and protocol writing required. Filing experience highly advantageous.
Experience in Cellular and Gene Therapies or Tissue Engineered Products strongly preferred and a strong grasp of this field is essential.
Knowledge of FDA regulations and guidelines related to IND and first in human trials is essential.
Experience in interactions with FDA personnel required including historic success achieving successful outcomes with global regulatory bodies is required, experience working with both CBER, CDRH and COER is strongly preferred.
Extensive experience in early stage development, first in human clinical trial design, and translational medicine.
MD/PhD preferred plus five years of relevant experience with FDA.
5 years' experience in clinical development associated with clinical trials.
Demonstrated experience leading multi-site or large-scale clinical trials research.
Demonstrated ability to work and communicate effectively with others, collaborate and build relationships across all levels of an organization.
Project management experience in a research environment.
Strong knowledge of industry standards and/or regulatory requirements.
Knowledge and experience including Good Clinical Practices, and Conduct of Clinical Research Studies.
Excellent written, verbal, interpersonal, and presentation skills. WORK STANDARDS:
Ensure consistency and adherence to clinical research guidelines, compliance with good clinical practices, good manufacturing practices and regulatory guidelines.
Interpersonal Skills: Demonstrates the ability to work well with colleagues and with external organizations.
Promote Culture of Safety: Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors based on training and lessons learned.
Subject to and expected to comply with all applicable policies and procedures.
Internal Number: PDIII-2
About Wake Forest Institute for Regenerative Medicine
Wake Forest Institute for Regenerative Medicine, Winston-Salem, NC
With a history of success and a focused strategy for getting new therapies to patients, the Wake Forest Institute for Regenerative Medicine (www.wfirm.org) is a premier research center of its kind. Our scientists were the first in the world to engineer laboratory-grown organs that were successfully implanted into humans. Today, our team is working to engineer replacement tissues and organs and develop healing cell therapies for more than 30 different areas of the body. Located in Wake Forest Innovation Quarter in downtown Winston-Salem, N.C., the Institute's labs include a dedicated current good manufacturing practice regulations (cGMP) facility, and were custom-built to implement our team-based operational philosophy.
Equal Employment Opportunity
It is the policy of Wake Forest Baptist Medical Center to administer all educational and employment activities without discrimination because of race, sex, age, religion, national origin, disability, sexual orientation, gender identity or veteran status (except where sex is a bona fide occupational qualification or a statutory requirement) in accordance with all... local, state, national laws, executive orders, regulations, and guidelines.
To Be Considered: send cover letter detailing interest, a current CV and two letters of recommendation to email@example.com.