Job Title: Director, Global Clinical Affairs

Description

Director, Global Clinical Affairs

Location: Virginia Beach, VA (Concert Drive)

Department: Quality

Job Type: Full-Time

Shift: Mon. - Fri.: 8:15AM - 5:00PM

LifeNet Health is searching for talented individuals who will embrace our mission of saving lives, restoring health, and giving hope.

LifeNet Health, headquartered in Virginia Beach, Virginia, is the largest nonprofit organ procurement organization ("OPO") and tissue processor in the United States, as well as a leading innovator in tissue engineering and regenerative medicine. Our goal is to improve the quality of human life through the provision of organs, tissues and cells for transplantation; to provide innovation in the fields of bio-implants, regenerative medicine and research; and, to serve the community with educational and support services that enhance the donation process. LifeNet Health has over 1200 employees and has a growing global presence.

How you will contribute to LifeNet Health's success:

The Director, Global Clinical Affairs establishes and oversees all clinical strategy and operations supporting product development and commercialization objectives of all LifeNet Health product portfolios domestically and internationally for 361 HCT/Ps, 351 HCT/Ps [BLA] and medical devices [510(k) and PMA]. Designs, establishes, coordinates, and executes clinical evaluations and related communications in support of these initiatives under adherence of Good Clinical Practice (GCP) and other regulatory requirements. Manages internal and external (physicians and other clinicians, research coordinators, project managers, biostatisticians, medical writers) personnel throughout entire life-cycle of each clinical evaluation, including subsequent scientific communications (abstracts, manuscripts and podium presentations). Partners with senior stakeholders in the business (Marketing, R&D, Contracts Administration and Finance) to ensure that clinical trial and health care professional agreements meet all applicable regulations and guidelines. Manages and conducts pharmacovigilance to support allografts regulated as drugs globally. Partners with stakeholders in the development of Risk Management Files for new and existing products in accordance with ISO 14971. Partners with Regulatory Affairs to write CTD submissions to support gaining regulatory approvals. Member of Corporate Compliance committee (Sunshine Act, HIPPA and human subjects' protection).

What you'll do:
Strategic Leadership: Provides strategic direction in the development of the Corporate global clinical evaluation and trial strategy through partnering with stakeholders (Franchise GMs, International, Life Sciences and Finance) to realize data to support new product launches, reimbursement for government and private payers, and increasing market share. Strategic considerations including but not limited to regulatory classification, availability of suitable patient population, ability to ensure human subjects protection, ability to economically monitor, cost of study, return on investment and publication and podium potential. Clinical Operations: Directs all clinical research operational activities related to LifeNet Health's products covering 361 HCT/Ps, 351 HCT/Ps [BLA - biologics] and medical devices [510(k) and PMA] and drugs. Interact and negotiate with global regulatory bodies on suitability of LifeNet Health clinical research protocols presented in support of pre-market approval or post-marketing surveillance. Develops clinical project budgets that align with strategic objectives, maximizes data vs cost and are fiscally sound. Insures timely delivery of status reports to the project stakeholders. Provides strategic planning and feasibility analysis for site selection, contract negotiations, vendor selection and patient recruiting programs. Negotiates clinical trial agreements and individual site budgets. Responsible for site identification, assessment and qualification, and training of investigators and site staff on clinical and research activities.Clinical Research: Drives initiation and execution of all clinical studies in alignment with established clinical strategies. Oversees clinical protocol development for all projects. Develops and manages the pre- and post-market clinical evaluation portfolio, including prospective trials, retrospective trials, literature reviews and case studies in alignment with corporate needs and in compliance with FDA, ISO, ICH/GCP and HIPAA requirements. Establishes and approves scientific methods for design and implementation of clinical protocols, data collection systems and final reports. Designs clinical studies including communicating directly with Principal Investigators regarding study design, execution, and management. Manages case report form development and approval. Leads and performs clinical monitoring activities as needed to ensure compliance with the investigational protocol, ICH/GCP, and other appropriate regulations. Reviews and resolves discrepancies in clinical data with clinical sites. Works with appropriate internal and external resources to define the statistical plan that drives study design and sample sizes and then analyzing data and preparing technical reports on clinical trial results. Interfaces with clinical investigators and Institutional Review Boards to ensure timely and compliant conduct of clinical programs.People Leadership and Relationship Management: Provides oversight to assigned team by supervising, guiding, and directing employees to be effective team members. Ensures that everyone is equipped with the right skills, tools, and talents necessary for executing their duties. Using the established people processes (performance, development, succession, and career) to ensure that their team's level of performance and capabilities meet current and future standards. Evaluates clinical staff performance and makes necessary adjustments to resolve issues and achieve related objectives. Provides daily leadership, prioritizes projects, and makes work assignments for all Clinical Affairs staff and external personnel necessary to timely initiate, conduct and execute clinical studies. Has indirect leadership responsibility, management, and influence over external CRO (Contract Research Organization) relationships to ensure timely implementation of clinical studies in accordance with GCP and other regulatory requirements. Manages and influences external relationships with regulatory entities responsible for overseeing and providing product approvals. Establishes, cultivates, manages, influences, and maintains long-term relationships with influential members of the medical research community as a company clinical/scientific ambassador. Develops and mentors internal and external clinical research professionals.Human Subjects Protection and Pharmacovigilance: Subject matter expert on human subjects' protections regulation. Directs all Institutional Review Board (IRB) submission efforts related to LifeNet Health clinical evaluations, recovery of research tissue and the Life Sciences franchise products. Supports grants submissions that involve human subjects by authoring human subjects' protection section. Ensures compliance with global pharmacovigilance regulations in applicable markets. Adjudicates adverse events collected from all LifeNet clinical evaluations and partner clinical evaluations on LifeNet products. Reports those events deemed to be related to LifeNet product to Quality Systems, IRB and applicable regulatory agenciesDevelopment of Clinical Trial Output: Oversees the development of manuscript, abstract, and poster publications to communicate data to the marketplace. Summarizes and condenses clinical evaluation results and technology assessments into publishable content and format in conjunction with clinical investigators. Maintains a repository for LifeNet generated manuscripts, abstracts and posters. Supports dossier submissions and other communications related to clinical evidence to US and OUS regulatory authorities. Supports development and maintenance of Risk Management Files, with respect to clinical data, in accordance with ISO 14971. Assists with regulatory agency submission efforts for new product development. Administrator for Science Direct (library search engine used across all LifeNet). Attends relevant scientific/medical meetings as needed. Creates clinical presentations, white papers, and training materials. Clinical Operations Infrastructure Management: Establishes and manages internal systems and SOPs to ensure that clinical trial and health care professional agreements meet regulatory requirements. Responsible for Fair Market Value Assessment process for all external consultants. Complies with LifeNet Health Quality Systems and Corporate Compliance Programs. Member of Corporate Compliance Committee.
What you'll bring (Minimum Requirements):Bachelor's Degree required; PH.D., MD, Pharm. D. in Biological Science or Nursing preferred. CCRP/CCRC/CCRA - Certified Clinical Research Professional/Coordinator/Associate required. CRCP -Certified Research Contracting Professional preferred. Ten (10) years Healthcare, Pharma or Biotech industry in clinical trials, manuscript development and investigator-initiated research required.Ten (10) years Clinical trials operations/administration required. Seven (7) years' experience managing direct/indirect reports required. Three (3) years Clinical Trials Project Management preferred. Three (3) years research compliance preferred.

These would be nice too (Knowledge Skills and Abilities):Working knowledge of FDA/ICH Regulations: Maintain compliance with FDA/ICH regulations and guidance. Project Management: Utilize project management skills including use of tracking program (MS Project). Good Clinical Practice (ICH E6-GCP): Demonstrated in-depth understanding of those regulations pertinent to clinical research and experience in clinical monitoring functions. Good Manufacturing Practices (cGMP): Experience/knowledge of medical device manufacturing regulations.Research/Problem Solving: Leads thorough analysis of situations with appropriate attention to detail and the big picture including consideration of impact at multiple levels of the system. Relationship Management: Builds and sustains partnerships across organizational boundaries and functions as well as outside the organization to achieve common goals and outcomes. People Development: Actively engages in talent management practices (selection, promotion, Job Description JD-TIS-0040 REV .00 development and engagement) to cultivate a workforce that is well aligned with current and emerging talent needs.Communication Skills: Written, verbal and presentation; ability to engage, inspire and influence people.Proficient in Microsoft Office
Why work at LifeNet Health?

We have a fierce drive for our mission of Saving Lives, Restoring Health, and Giving Hope. You won't find another company with a culture as strong as ours.403(b) and Pension PlanMedical, dental, and vision coverageCorporate sponsored events Work-life balance with generous paid time offTuition reimbursementPersonal career and skill development opportunitiesWellness ProgramEmployee Assistance Program (EAP)Dedicated and passionate co-workers

We are proud to be an EEO/AA employer EOE/M/F/Disability/Vet. We maintain a drug-free workplace and perform pre-employment substance abuse testing.