Chris A. Learn, Ph.D, Pmp Email & Phone Number

Chapel Hill, Nc, Us

To accelerate research in biomarkers for early diagnosis of high risk conditions that affect brain function and to develop novel targeted curative therapies based on molecular causes of these conditions discovered through epigenetic and genetic research. To provide parents and health care professionals objective tools to support development of children very early on as infants and toddlers based on objective behavioral assessments.We are born with inherent characteristics that define our personality and who we are. Some of us learn to thrive and some of us struggle to master and learn how to cope with our environment. For the majority of us this is not because we have mental health conditions but it is because we are not equipped to thrive in the environment we live in. We at CHCF believe that each person is very unique. We also believe that in order for our children to thrive emotionally we must have objective diagnostic tools that could identify 1) the optimal thriving environment for each child early on and; 2) how each child can learn critical skill sets to cope with inevitable adverse events exposed to in the existing global environment. To do so this requires a new approach in understanding who we are early on in life through genetic and epigenetic research so we can find a place we can call home! We invite you to join us if you believe in this mission. We can do better.CHCFbrain non-profit is unique in that its focus is on research into the root causes of serious brain disease in order to, one day, prevent them from becoming debilitating and life-threatening conditions.

Durham, North Carolina, Us

Durham, North Carolina, Us

Durham, North Carolina, Us

• Serve as Senior Clinical Scientist to provide oversight and direction of development strategy to ensure program outlays and budget meet company goals.• Act as central lead for the program, its policies and practices in order to continuously shape the direction of Istari’s glioblastoma clinical development.• Ensure individual protocol, asset and program strategies align with corporate goals.• Drive the GBM clinical sites, operational teams and vendors to leverage and consolidate all available data to build the project strategy in pursuit of BLA submission and other key program milestones.• Liaise with all vendors in the role of program operational oversight to ensure execution, budget and deliverables.

Durham, North Carolina, Us

• As the IQVIA Cell and Gene Therapy (CAGT) Clinical Operations Strategy Lead, I was responsible for working with a broad range of sponsors, developing clinical operations approaches and innovations for the execution of CAGT studies. • The key remit of the role was to drive growth of the IQVIA CAGT portfolio through clinical operations expertise. • This role required using clinical operational knowledge to harness the IQVIA data and clinical trial resources to develop innovative, data-driven, and patient-centered solutions for CAGT trials.

Dublin, Ie

• To provide leadership to effectively coordinate and manage the activities of one or more large cross functional multinational studies or a program of studies and project teams in a manner that ensures all time frames and targets are met and that costs are kept under control. • Develop full service project plans for a program of studies and subsequently lead cross functional study teams in accordance with contractual timelines, client specifications and Good Clinical Practices (GCPs).• Coordinate and manage the activities of individuals, studies and staff in a manner that ensures all time frames and targets are met and that costs are kept under control.• Effectively manage assigned staff to ensure high performance, continuous development and low turnover.• Ensure all necessary training is provided to assigned staff to improve their job performance and knowledge.• Identify risks to critical path for drug development and define ways to mitigate.• Manage projects in accordance with the contract. Proactively recognize any changes in scope and collaborate with the relevant to ensure timely completion of change orders.• Effectively manage study budgets to ensure financial targets are met through regular review of indirect costs and project resources.• Implement QC procedures and monitor quality metrics to ensure a high quality standard is maintained throughout assigned projects.• Lead succession planning and development of study/program key staff.

King Of Prussia, Pa, Us

• Accountable for the clinical/scientific execution of the clinical protocol and scientific aspects of the implementation and conduct of a clinical trial (medical monitoring, safety oversight, investigator meeting presentations) • Collaborate with the Medical Writer on clinical/scientific and regulatory documents and Study manager on study deliverables• Liaise with cross-functional lines as appropriate • Provide tactical/scientific mentorship to other clinical scientists

King Of Prussia, Pa, Us

• Protocol (Scientific) Lead in Oncology Therapeutic Area• Lead and direct team in scientific study planning, development and delivery• Author clinical protocols, clinical study reports, regulatory agency update reports, responses to regulatory agencies, and other clinical and regulatory documents• Support Clinical Directors in scientific leadership/investigator initiatives including preparation of publications, meeting presentations• Manage trial level communications and activities• Lead and direct team for timeline management, risk identification and mitigation, issue resolution• Facilitate and collaborate with key internal/external stakeholders in support of clinical trial objectives• Manage trial-specific partners and vendors

Durham, North Carolina, Us

• Project Manager for global studies in support of oncology investigational products from Phase III large capital to Phase I/II venture capital biopharma• Therapeutic Compound Lead for large development programs for Investigational Products currently in development in Phase I - Phase III Oncology • Responsible for scope of work, objectives, quality of deliverables, budget and financials • Provide consultation to clients on drug development process, strategy and plans as needed• Participate in sales/proposal presentations in face-to-face meetings with potential clients• Primary project contact for Sponsor to ensure operational metrics, accountability and success• Develop project plans for all phases of the project lifecycle

Raleigh, North Carolina, Us

• Project Manager for Clinical Data Analysis and Information Support to over 300 hospitals and 800 surgeons nationwide• Team leader for company-wide Research Division Training and Education Programs for all employees• Developed and implemented costing for all external research requests to Research Division • Designed and implemented Adverse Events module for national real-time reporting longitudinal patient database (BOLD) for Patient Selection and Risk Stratification• Affiliate Assistant Professor, Department of Surgery, Brody School of Medicine, East Carolina University

Research Triangle Park, Durham, Nc, Us

• NIH-funded investigations into how human lymphocyte responses are normally configured and leveraged in response to therapeutic resistance • Use of functional genomics to dissect underlying mechanisms involved in human immune response to toxicants, neoplasia or the human immunodeficiency virus (HIV)

Durham, North Carolina, Us

• Continuous intramural and extramural research support through the NIH and private foundations • Author on three separate clinical trials initiated at Duke University Medical Center: VICTORI, ACTIVATE, ATTAC• In vitro diagnostic development to support trials work and validation• Development of INDs and clinical SOPs; Adverse Event reporting to FDA in support of trials work• Consultant for ImClone Systems, Inc. on product launch of Erbitux

Master Of Business Administration - Mba, Business Administration And Management, General

Doctor Of Philosophy, Microbiology And Immunology

B.S., Biology, Chemistry