We need strong candidates who will be highly motivated, and will have exceptional scientific creativity, good organizational skills, and effective communication skills (written and oral). The applicant should have the ability to work both independently to design and conduct experiments, as well as the ability to collaborate effectively with team members inside and outside the immediate lab environment. Evidence of productivity in regards to publications, funding applications and research achievements is required. The position offers a competitive salary and exposure to a rich and highly collaborative scientific environment.

Relevant experience in one or more of the following categories is also desirable.

• 3D cell culture, organoid fabrication and characterization, disease modeling
• Biochemistry, biomaterial chemistry, hydrogels development
• Microfluidic development for biological applications, fluid (gas/liquid) modeling and control
• Chemical, biochemical and biological sampling, assay development and standardization

At varying levels of skill and experience, and under a general supervision plan, lab techs develop, modify, and implement previously developed and original experimental procedures in the research.

Responsibilities include:

• Perform routine and non-routine tests and analyses using the appropriate technical equipment and instruments
• Receive or collect, as well as process, samples
• Calculate test results, and log and report results with appropriate graphing and statistical software
• Prepare and supervise experiments
• Perform quality control and calibrate equipment if necessary
• Maintain equipment in proper working order and maintain a clean work area
• Practice safe work habits, including complying with all safety, health, and environmental rules and regulations

Minimum Qualifications for Lab Technician

• High school diploma or general education degree (GED) required, associate's or Bachelor's degree in a scientific field preferred
• 1-2 years of experience working in a lab
• Computer skills: knowledge of Microsoft Office and other relevant computer programs
• Analytical and numerical skills: ability to perform mathematical calculations (add, subtract, multiply, divide) in different units of measurement; ability to use concepts such as fractions, percentages, and ratios
• Strong attention to detail
• Ability to write correspondence and reports
• Excellent organizational skills
• Ability to perform physically demanding work such as moving and lifting equipment, standing for long periods of time, etc.

Desired skills or Expertise

• Cell culture, primary cell isolation and characterization, 3D culture methodology
• Biochemistry, chemistry, biomaterials
• Engineering, microfluidics, fluid (gas/liquid) engineering
• Performance of chemical, biochemical and biological assays
• Experience with transcriptomics, proteomics or metabolomics 

Program Director III - Regulatory Affairs- Preclinical

This position is responsible for the strategy and oversight of the Regulatory Affairs Non-Clinical development function. This position will support the expanding pipeline of products in development 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 the Non-Clinical Section of an IND, review and submission of documents to regulatory authorities, and maintaining compliance with applicable regulatory requirements.

A strong background in Regulatory Toxicology and pre-clinical animal studies including knowledge and understanding of Good Laboratory Practices (GLPs),  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 and have a minimum of 5 years' experience with FDA in an applicable role. Responsibilities will also include subject matter expertise relating to preclinical pharmacology, toxicology and ADME sections of 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 preclinical/non-clinical regulatory strategies and the reparation and submission of high-quality non-clinical sections of INDs in close collaboration with our scientists and in-house RMCC Process/Product Development, Manufacturing and Quality Teams, and Collaborators.

Responsibilities

• Represent the non-clinical regulatory function on cross-functional development teams.
• Provide regulatory guidance and strategy including identifying and assessing regulatory risks, mitigations, and contingencies in non-clinical effort.
• Plan, prepare and review non-clinical sections to regulatory authorities to support FDA INTERACT program, Pre-IND, Pre-IDE and early phase clinical trials.
• Lead and oversee non-clinical regulatory activities for assigned projects other applicable requirements to ensure compliance.
• Manage the non-clinical regulatory aspects of products and projects including achievement of timelines and deliverables.
• Ensure that regulatory documents are accurate, complete and verifiable, and confirm compliance with regulatory requirements.
• Monitor, analyze, and disseminate intelligence on non-clinical regulatory matters that may affect ongoing development programs.
• Provide interpretation of and advice regarding non-clinical regulations, directives, and guidance. Prepare meeting requests, briefing documents, coordinate and prepare teams for meetings, and interface with regulatory authorities; be primary liaison with regulatory authorities for day-to¬ day interactions
• Coordinate and prepare non-clinical responses to requests for information from regulatory authorities
• Provide leadership and oversight of the Non-Clinical/Preclinical Regulatory Affairs.
• Provide Non-Clinical regulatory strategy in design of non-clinical development programs leading to IND enabling studies.
• Determine overall Non-clinical regulatory strategy regarding early stage clinical protocol development.
• Work closely with cross-functional teams to ensure non-clinical development programs are aligned with for early stage Clinical Trials.
• Develop and execute sound non-clinical regulatory decisions and justifications
• Comply with all pertinent SOPs and GLP regulations.
• Represent Wake Forest Institute for Regenerative Medicine in a professional manner, foster a cooperative and team relationship with partner organizations.
  

Qualifications

• PhD/PharmD or DVM in a scientific discipline preferred along with at least 5 years of experience in industry relate<i Regulatory Affairs and 5 years' experience at the FDA in an applicable position.
• Knowledge and understanding of non-clinical global regulations and guidelines
• Previous experience in the preparation and submission of non-clinical regulatory documents
• Strong attention to detail and the ability to handle multiple tasks
• Excellent organizational, computer and documentation skills and an ability to prioritize effectively
• Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment
• Proven regulatory leadership experience in a cross-functional role with non-clinical product development experience.
• Strong technical knowledge of non-clinical development.
• Strong knowledge and interest in the evolving landscape of novel clinical development programs.
• Oversight of design, conduct, interpretation, and reporting of all regulatory non-clinical studies including resulting risk assessments.
• Plan, design, and effectively manage/conduct and oversee designated toxicology programs necessary to support the selection and timely development.
• Coordinate toxicological/preclinical safety evaluations of development candidates with internal, external contract laboratories, consultants, faculty and RMCC.
• Address and resolve toxicological issues arising in drug development programs, and adequately assess the relevance of any toxicological findings to human safety.
• In depth understanding and working knowledge of regulatory toxicology, GlPs, and US and International Regulatory Guidelines
• Strong problem solver who is highly organized with the ability to thrive in an environment with rapidly changing priorities
• Advanced scientific writing skills.
• Experience in animal Pharm/Tox studies/models, including protocol design & study conduct
• Maintains a compliant work environment by staying current with SOPs and being up-to-date with existing GLP guideline

 

 

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Program Director III - Regulatory Affairs- Clinical Trials

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.
 
Responsibilities:

• 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.

Preferred Qualifications:

• Knowledge of hypothesis-generating and experience In hypothesis-testing scientific research project
• 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. 
  

Qualifications:

• 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.

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Program Director III - CMC Regulatory Affairs

 
This position is responsible for the CMC Regulatory Affairs, which includes providing strategic and operational leadership in the development and execution of the CMC.
 
This position will support the expanding pipeline of products in development and manufacturing from a regulatory perspective.  The successful candidate will provide leadership and work closely within The Regenerative Medicine Clinical Center and other areas within the Institute. This includes the development and implementation of regulatory strategy, ensuring timely preparation for the CMC Section of an IND, review and submission of documents to regulatory authorities, and maintaining compliance with applicable regulatory requirements.
 
The successful candidate will serve as a resource to team members for the regulatory requirements to conduct manufacturing and testing activities for regenerative medicine products and have a minimum of 3 years' experience with FDA in an applicable role.
 
The successful candidate will be responsible for driving the CMC regulatory strategies and the preparation and submission of a high-quality CMC section of IND in close collaboration with our in-house RMCC Process/Product Development, Manufacturing and Quality Teams, Faculty, and Collaborators.
 

Essential Duties and Responsibilities

Regulatory Affairs:

• Work closely with the leadership team, lead the development of regulatory strategies and objectives that result in the successful Development and Manufacturing of products in clinicaltrials or regulated under 21CFR 1271. Consideration for Design Control and compliance to 21 CFR 820.
• Serve as regulatory agency contact {with the FDA and at other agencies) to achieve regulatory objectives for CMC, by fostering strong relationships and acting as a credible,reputable and effective advocate for RMCC and WFIRM.
• Serve as key point of contact in relation to managing and directing regulatory inspections.
• Keep peers and superiors apprised of expected changes to the regulatory landscape affecting existing and future products and provide strategic and tactical direction to drive efficiency and safety in the regulatory approach.
• Develop and design robust regulatory structure, processes and procedures and budget forecasting based on expert understanding and insight of future regulatory policy.
• Partner with and support product/process development and CMC including the review and submission of manufacturing in clinical protocols and regulatory documents, publications throughout the product life cycle.
• Direct long- and short-term CMC regulatory planning including structure, training, and systems requirements.

Education

• Graduate degree required, PhD preferred
• RAPS/ RAC desirable

Experience

• 15+ years' experience leading Regulatory Affairs within industry with 5 years of specific leadership and management experience and 3 years' experience in FDA associated with CMCreview.
• Experience leading the Regulatory Affairs specifically the designing, writing, and submission of regulatory filings and correspondence within a similarly complex product.

Skills/Attributes

• Strong leadership competencies and strategic business perspectives required, to ensure that sound product development, regulatory and compliance practices are followed.
• In-depth understanding of the development and life cycle management process for Regenerative Medicine Products including Biologics, Drugs, Devices and Combination Products.
• Expertise in Quality and Compliance as well as experience in managing and preparing for regulatory inspections.
• Proven interpersonal and influencing skills. This includes a demonstrated ability to use an open and supportive communication style and to work cross functionally with multiple teams.
• Excellent oral and written communications skills.
• Commitment to achieving institutional mission while maintaining the highest ethical, regulatory and scientific standards.
• An entrepreneurial, innovative, energetic, hands-on, team oriented attitude and approach.
  The ability to think strategically as well as execute project details.

Grants Administrator 

Coordinate a variety of administrative research activities including pre-award efforts, proposal submission, and post-award management to assure that research projects comply with institutional and sponsor requirements.

Function of Job

Facilitate grant and/or contract submission by providing guidance to faculty within the Institute including preparation of applications, institutional requirements, and administrative processes.

Under administrative review, coordinate a variety of administrative research activities for assigned departments, including pre-award efforts, proposal submission, and post-award management to assure that research projects comply with institutional and sponsor requirements.

Develop resources within the Institute to assist investigators in the preparation and submission of proposals and administration of awards.

Characteristic Work

• Pre-Award Activities 
• Support faculty research interests and expertise by identifying appropriate potential sponsors and programs, communicating funding opportunity information to faculty by tracking information via computerized and written sources. 
• Obtain and review guidelines for requests for proposals and requests for applications to recruit and assist faculty applications.
• Assist in the coordination of site visits to/from study sponsors.
• Function as liaison with study sponsors; coordinate sponsor updates of grant information.
• Provide examples of various types of grant applications to investigators.
  

Project Development/Proposal Submission 

• Obtain and coordinate proposal components from various participants.
• Create grant budgets from investigator outlines; prepare and assemble supporting documents to assist PI in writing of budget justification.
• Coordinate the preparation of “boilerplate” materials (i.e., other support, resources and environment) for grant applications and maintain them online.
• Monitor regulatory application compliance (e.g., ACUC, IRB) and internal routing forms are submitted in a timely fashion.
• Provide technical advice regarding administrative and financial aspects of proposals, budget, budget justification, subcontracting, indirect cost rates, fringe benefit rates, etc., to investigators within the Institute.
• Assure that sponsor requirements are met (i.e., proposal format, page limits, number of copies).
• Enter proposal information into the institutional database and submit for institutional review and approval.
• Create, coordinate and review subcontracts grant applications.
• Perform post-submission follow-up with sponsor. 
  

Post-Award Management 

• Log project actions into institutional database (i.e., awarded, not awarded, etc.)
• Assist in the preparation of re-budgeting requests. 
• Arrange for and document the acquisition of equipment. 
• Assist in maintaining effort information; prepare and approve personnel actions related to project.
• Work closely the financial coordinator in assisting faculty members prior to the end of a grant to verify funds are spent appropriately, or request for carryover of funds.
• Assist in the development of grant and contract budgets 
  

Compliance Management 

• Coordinate the submission of ACUC, IRB, radiation safety, biosafety, and other regulatory protocols in conjunction with investigators.
• Track status of protocols and grants submitted to the Office of Research and follow up as necessary.
• Monitor and advise faculty on regulatory changes.
• Assist Faculty in the development of Conflict of Interest management plans in conjunction with the Office of Research. 
• Perform other related duties incidental to the work described herein.
  

Supervision Received and Given

• General oral and/or written instructions are received from supervisor.  Provide direction and supervision to support personnel as assigned.
  

Minimum Acceptable Qualifications

• Bachelor's degree in a related field or equivalent experience.
• Three years’ experience with grant preparation and/or management of grant budgets.
• Excellent interpersonal skills. 
• Ability to deal effectively with the faculty, staff, and sponsors.
• Excellent oral and written communication skills. 
• PC experience, including word processing, spreadsheet, and database software.
  

Additional Desirable Qualifications

• Research-related experience 
• Financial experience