Project Management Clinical Trial

CHRISTIAN OHAERI

Pharm.D., MBA

*******@***.***

HTTPS://www.linkedin.com/in/christian-o-haeri-ob342836/

** ******* *****, .**********, ** 609-***-****

The Job Title here

With over 15 years of experience in the global pharmaceutical and healthcare sectors, I bring a rich blend of clinical expertise, regulatory knowledge, and strategic leadership to my roles. I have excelled in developing training curricula, ensuring regulatory compliance, and fostering collaborative partnerships across various therapeutic areas healthcare systems. My hands-on experience ranges from clinical trial management, drug safety, labelling and project management. I thrive in dynamic environments, leveraging my background in oncology, cardiovascular, metabolics, infectious diseases, HIV, immunology, CNS & GI therapeutic areas to drive impactful outcomes and enhance patient care. Outside of work, I am passionate about continuous learning and staying abreast of industry advancements.

Areas of Expertise

Clinical Research Operations

Clinical Trial Management

Regulatory Documentation Preparation /submissions

Project Management

Curriculum Development

Sales Force Training

Regulatory Compliance

Clinical Drug Supply Chain

Drug Safety Monitoring & Medical Affairs

Drug Promotional Review & Commercialization

Pharmacovigilance

Labelling & Packaging

Market Access Strategy

Medical Communication & Publication

Business Development

Phases 1 to 4 clinical trial experience

Government pricing design and management

Outcomes Research

Accomplishments

Collaborated with medical affairs, clinical research, opinion leaders, sales and marketing in updating, developing medical training materials & drug promotional review for treatment, prevention and prophylaxis of HIV, oncology, cardiovascular, metabolics & CNS, training sales force/field medical scientists for better healthcare interactions.

Updated clinical database responses to FDA inquiries, ensuring regulatory compliance & aacuracy of drug promotional review documents for the sales force, healthcare professionals and payers.

Used labelling committee to achieve FDA’s product labelling approval, overseeing labelling compliance, ensuring modifications to labelling are well documented, labelling audits & maintaining documentation of labelling processes.,

Implemented market access & expansion strategies for cost-effective pricing and services.

Reviewed and approved promotional materials, ensuring compliance and management of business relationships.

Supported successful IND, NDA, & CTA filings and product registrations, with contributing to development of protocols, IB, ICF, Biomarkers, $ SAP.

Enhanced pharmacovigilance processes, ensuring global compliance and managed phases I to IV clinical trials, maintaining GCP compliance.

Facilitated successful execution and adherence to timelines, budgets, project, quality plans, relevant ICH/GCP guidelines and clinical trial milestones activities as appropriate.

Employed integrated practices to ensure the medical information provided is accurate and reliable to maintain patient safety, regulatory compliance, company’s integrity, including managing conflicting data from different sources with a systematic approach to ensure the most accurate and reliable information was used.

Strong organizational and cross-functional project management skills, strong technical background with understanding of pharmaceutical manufacture and commercialization, critical thinking skills, decisive judgment, and the ability to work independently.

Career Experience

Independent Contractor, SAPIT Consulting LLC, Rockville MD/Bronx Care Hospital, CPEP,Bronx NY 04/2023 to Present

Partnered with Training and Development to train sales force/field medical scientists on HIV, oncology, cardiovascular, metabolic & CNS diseases to enhance medical and scientific knowledge and ensuring the accuracy/consistent scientific information in drug promotional review materials.

Improved sales team's ability to handle objections and comparative analysis raised by healthcare professionals.

Ensured compliance with FDA and other regulatory agencies' requirements for drug promotion and commercialization.

Reviewed clinical database for FDA inquiries, updating drug safety and promotional materials for health professionals.

Updated drug safety core data sheets, investigator brochures, labels, post-marketing surveillance and drug promotional activities.

Performed literature reviews and extracted complex data from secientific literatues for itegration in relevant documents and promotional drug review materials.

Collaborated with medical affairs, regulatory and clinical trial teams to achieve accurate and consistent product information.

Collaborated with medical affairs, regulatory, management, sales and marketing to develop Medicaid, Medicare, and department of defense drug pricing strategy in compliance with government pricing calculations, performed regular analyses to ensure data accuracy and consistency.

Established prior authorization processes in collaboration with the P&T committee, physicians, nurses and management in accordance with hospital policy and medical department requirements to ensure effective integration into the hospital-wide pharmaceutical care services; acted as a clinical pharmacist expert on prior authorization review, evaluation and resolution of case reviews in accordance with clinical criteria and insurance coverage plan design, reviewing and evaluating clinical literature resources to support decision-making and recommendations to providers.

Pharmacy Manager, Westchester Avenue Pharmacy, Bronx NY 01/2013 – 03/2023

Managed effective partnerships of internal and external stakeholders, global publications and vendor medical writing teams, ensured development of high quality and accurate abstracts, posters, manuscripts and presentation materials met company’s publication goals with the management of writing activities of external agencies and internal medical writers with emphasis in ensuring accuracy and compliance of drug promotional review requirements and prompt responses to FDA or competitors complaints on company drug promotional activies.

Collaborated with medical affairs, regulatory, marketing, clinical trial investigators and opinion leaders to develop and execute medical affairs publication strategy including managing congress presentations and manuscripts of clinical trials results and health economics outcome research publications within timelines and budget, as well as maintaining clinical data integrity and scientific fair balance, compliance with regulatory and industry requirements.

Designed a publication plan for metabolics, HIV and Immunology, CNS, and oncology products and collaborated with medical affairs, clinical investigators, regulatory and medical communications company to develop publications using Datavision.

Supported market access and expansion strategies, collaborating with healthcare systems for drug formulary reviews/promotional materials, cost-effective pricing, perfoming literature reviews, extraction of complex data from scientific literaturs for use in publications and drug promotional activities.

Developed pricing and value-added services with marketing and medical teams, training sales force for competitive markets.

Reviewed and approved promotional labeling materials, ensuring compliance with regulations & accurate product information.

Managed product registrations, adverse drug reaction reports, regulatory submissions & generated scientitifc responses.

Provided business stakeholders with actionable insights/recommendations based on knowledge of products/customer interactions.

Participated in cross-functional project teamts, ensuring completion of assigned projects on schedule, within budget/accuracy.

Served as a knowledge resource of pertinent competitive strategies for labelling, publication and medical communication and healthcare systems drug formulary management.

Directed and managed all aspects of the pharmacy operations, clinical research activites, project design & approval processes, budgeting, accountable for compliance with regulatory requirements, ensuring customer and client satisfaction, profitability and mentoring and supervisory of staff.

Collaborated with medical affairs, regulatory, management, sales and marketing to develop Medicaid, Medicare, and department of defense (DOD) drug pricing strategy, ensuring meeting government pricing calculation requirements in addition to performing regular analyses to ensure data accuracy and consistency; developed strong relationships with internal teams and vendors involved with government contracts and accounting processes to ensure building a credible business reputation and trustworthy admirable integrity.

Director of Pharmaceutical Care Services, Women’s and Children’s Hospital, Lafayette LA 2/2012 – 11/2012

Directed/managed medication management and clinical research as a source of generating revenues/retaining research oriented physicians including training naive investigators on protocol, informed consent, investigator’s brochure, lab manual designs,

Ensured effedtive communication, regulatory documentation, ongoing oversight of assigned trials by collaborating with other functional teams; identifying challenges to study timelines, deliverables and offered creative action plans to the team/sponsor.

Collaborated with CRAs for high quality oversight of monitoring, regulatory, IP, site payment and overall site correspondence.

Managed phases 3 and 4 studies in collaboration with CROs, authoring and reviewing protocols and data collection tools.

Led clinical trial teams, providing training, medical review of data, data cleaning, study close out & ensuring completion of trial deliverables, establishing strong partnership with functional and regional operational managers to drive operational excellence.

Collaborated with Global Development Operations, Medical, and Regulatory Affairs on clinical program content.

Ensured strategic and operational execution of clinical programs and product labeling.

Advised on regulatory strategy for INDs, CTAs, and license applications.

Contributed to and presented at regulatory meetings (e.g., pre-IND, end Phase II, Advisory Boards).

Associate Director, Drug Supply Operations, MorphoTek Biotic, Eaton PA 2/2010 – 01/2012

Directed global drug supplies development programs, overseeing internal clinical operations staff and external contract organizations, and external stakeholders.

Led competitive intelligence processes for medical and pharmacy drug labeling and promotion to enhance competitiveness, monitoring drugs in competitors’ pipelines and compared their labelings with ours to determine labeling modifications based on new clinical data.

Managed projects and teams of study designs, clinical sites selections, contract negotiations; oversaw CROs and vendors, collaborating on budgets and timelines, provided guidance to cross functional project teams on complex issues, status updates and analyzing project shortfalls for corrective actions.

Authored and contributed to various therapeutic clinical studies and regulatory documents including study protocols, IB, ICFs, Biomarkers and SAP, IND, AND NDA submissions.

Led review of clinical trial data for data integrity, data trends, and analysis for Interim and final reports and updates to global regulatory agencies on oncology, contributing to the development of oncology advocacy and policy strategies which led to ovarian and non-small cell lung cancers advocacy.

Established and monitored drug pipeline competitive intelligence processes, leading internal team of clinical pharmacists and financial analysts as a subject matter expert in oncology therapeutic drugs.

Planed, tracked, and managed all aspects of trials, including financial, regulatory, investigators and marketing-initiated trials in collaboration with clinical development to ensure successful completion of trials.

Utilized medical affairs, clinical data, regulatory, publication, marketing, authors, external publication vendors and stakeholders teams to track database entry, updates, reports/communicating publication projects/deliverables for completion of publications.

Additional Titles Held:

Global Director, WHO and US Pharmaceutical Alliance on global health initiatives

Director of Pharmaceutical Care Services and Clinical Research, Sempercare, Belleville NJ /St. Mary’s Medical Center, Huntington, WV Director of Pharmaceutical Care Services East Orange NJ/General Hospital, Olean NY

Project Director, OmniCare Clinical Research, King of Prussia, PA

Director, Clinical Research, Bracco Diagnostics, Princeton, NJ

Manager Medical Marketing/Outcomes Research, Bristol-Myers Squibb, Plainsboro, NJ

Director, Pharmaceutical Care Services, NYC Health & HC, NY, NY

Education

PharmD, Doctor of Pharmacy, University of Minnesota, Minneapolis

MBA in Marketing, Rutgers University NJ

BS Pharmacy, University of Minnesota, Minneapolis

Clinical Research Fellowship in Cardiovascular Pharmacotherapy/Cardiac Transplantation, UNC

Professional CertificationsRegistered Pharmacist in NJ & NY States

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