Alexandru Ionel

Purpose:

• To provide medical expertise in the planning and execution of clinical trials and to oversee the medical aspects of trial conduct, ensuring adherence to ethical, regulatory, and clinical standards.
• To oversee the operational aspects of clinical trials, ensuring effective management, execution, and compliance with regulatory standards for Phase I and Bioequivalence Studies.
• Maximize value from medical, clinical trials execution, registration, quality affairs and pharmacovigilance, according to business strategy and the objectives of the company and client.

Main responsibilities:

• Oversee clinical trial design, implementation, and compliance with GCP and international regulations, ensuring the integrity and safety of studies and its participants.
• Manage clinical operations, including team coordination, vendor selection (e.g., CROs, labs), and oversight of trial progress, timelines, and budgets.
• Ensure team development and deployment in Phase I and Bioequivalence Unit, for flawless projects (studies) execution.
• Provide strategic medical guidance, leading medical monitoring activities, reviewing safety data, and managing adverse events, ensuring medical and scientific accuracy.
• Coordinate with regulatory authorities for trial applications, submissions, approvals, and safety reporting, ensuring regulatory compliance.
• Develop and implement risk management and mitigation strategies in clinical trials, fostering cross-functional collaboration to align medical strategies with business objectives.

Purpose:

• To maximize the value generated from the provision of medical information services, execution of clinical trials, registration and quality affairs and pharmacovigilance.
• To represent company vision, values, commitments in the daily conduct with the customers.

Main responsibilities and achievements (Novo Nordisk):

• Developed a strong KOL management and activity plans to support affiliate pre /launch plans and engage in sustainable partnerships
• Co-work with Market Access to raise diabetes and now obesity high on the public health agenda - contributing to the outcome of issuing a Prevention Law;
• Starting the working group for obesity (to raise awareness, design a therapeutic program and support activities): Romanian Obesity Forum (“FORO”) joining several medical associations and issuing “National Recommendations for the management of people with obesity”
• Managed local Clinical team to re-adjust to current challenges and adapt to future trials and new therapy areas (Obesity, NASH, CV, Alzheimer)
• Managed qualitative team transformation, with focus on Medical Affairs and increasing effectiveness (Diabetes, Obesity and Rare Disease Medical Affairs & Clinical).
• Contribute to business cross-functional integration of local affiliate (Brand Teams, One Activity Plan for all, develop Agile teams).
• Added responsibilities from Mar 2020 to Jan 2021 (acting directly as interim-Clinical Research Manager):
• Execute the Regional Clinical Development Centre Strategic Plan
• Maintain the best-in-class trial execution and quality

Purpose:

• To develop an industry leading Country Medical Organization (Medical Affairs, Clinical Development & Drug Regulatory Affairs).
• To drive the Medical agenda within the local organization in line with Global, Regional and Country needs, to deliver highest possible patient access to Novartis products.
• Added responsibilities in DRA (Drug Regulatory Affairs):
• Coordinates preparation for all documentation required to ensure that all Novartis products sold in Romania are in accordance with the regulations and provisions in force regarding the marketing authorization.
• Ensure clear communication channels between local DRA organization and Health Authority, as well as with regional departments of Development, Regulatory Affairs, Clinical Trials and Corporate Relations.

Purpose: To ensure oversight and coordination of QA department for all activities required by regulations and Local QA Plan.

Added responsibilities:

• Achieve timely Health Authority issuing of Import & Distribution Licenses to allow implementation of the Fully Fledged CPO project.
• Ensure QA support for the related Health Authority inspection.

Purpose: To ensure Medical governance support of the respective Pharma Organizations.

Added responsibilities: Advice on and approval of activities from the compliance perspective and oversight (for Medical Affairs).

Main responsibilities as CSO:

• Develop and manage a solid Medical department, driving the Medical agenda within the local organization, in line with Global, Regional and Country needs.
• Strategically lead Clinical Development and Medical Affairs for both global Development and the local businesses, ensuring effective and efficient clinical operational and business support for Novartis inline and pipeline products.
• Represent Novartis at key external Scientific, Clinical, Medical and Regulatory meetings.

Main responsibilities:

• Drive the implementation of Compliance Organization and Program across divisions, provide function coordination and oversight for Compliance activities and identify cross-divisional synergies
• Assess Compliance risks, coverage, skills and resources at local level and develop plans to upgrade these
• Act as main interface between Group Integrity & Compliance and Local level and address strategic priorities at a local level.

Main responsibilities:

• Promote speak-up and integrity culture, actively involving country leadership to maintain high level of awareness (Tone from the Top).
• Establish Compliance standards, processes and SOPs based on internal policies and guidelines (Code of Conduct, Business Practices Office, Anti-Bribery and Promotional practices code) and on applicable local laws, regulations and industry code, ensuring the most stringent is applied.
• Drive ethical business conduct, implement the Integrity & Compliance program, and provide advice and guidance to the business on compliance related topics. Assess risks and regularly update country & regional leadership on the status of the risk mitigation programs.

Main responsibilities:

• Medical Head: Provide medical and clinical development expertise to drive Novartis message delivery to key influencers and stakeholders. Provide input and ensure alignment between global project strategy & local needs to drive Medical Affairs in the local business franchise. Manage local organization associates on assigned projects.
• Drug Safety & Epidemiology (DS&E): To support management of DS&E operational processes at Country Pharma Organization (CPO) in ensuring compliance with Novartis global/local procedures, national and international regulations/ standards/guidelines for Pharmacovigilance of Novartis marketed and investigational products.
• For Compliance Officer – please see below
• For HSE Officer –implementation of specific HS&E objectives, in compliance with local and Novartis regulations
• Achievements (Novartis Pharma Services Romania):
• Managed and oversight of a well-functioning Pharmacovigilance System in Novartis Pharma Services Romania, as confirmed by the Health Authority Inspection (July 2007) without critical or major findings, as well as subsequent PV audits. Smooth implementation of E2B reporting to NMA.
• Implemented / updated of a solid framework of local SOPs (Local Working Procedures), to ensure processes’ excellence. No critical findings during HA GCP Sponsor and site inspection (September and December 2007, November 2014) and internal GCP Audits.
• Ensured support for the local ICRO (ClinOps) team for higher quality activity, reflected in top ICRO KPIs worldwide / Region and team stability and positive audit results (more than 10 audits). Novartis Romania was number one Pharma sponsor for global Clinical Trials in Romania (2010 to 2015).
• Strengthened the Medical-Marketing-Sales collaboration and supported implementation of a KOL Management Tracking Tool. Further contribution to the Brand team and cross-functional matrix model of work.
• Innovate the way we work in Medical Affairs: partnering with Medical Experts and stakeholders, having their strategic input within Medical Brand and cross-functional Teams.
• Raised Quality in execution of Post Marketing Surveillance Studies by creating dedicated qualified resources, a unit to implement Local trials.

Main responsibilities:

• Plan, implement, coordinate and facilitate phase I - III clinical studies on vaccines in Romania, in order to ensure that the clinical trials meet with required standards of GCPs / SOPs as set forth by GSK Biologicals Vaccines Headquarters.
• Review and give input to the protocols from GSK Biologicals to meet local regulatory requirements, prepare and finalize phase I-III and epidemiological study protocols, ensure timely conduct of clinical studies according to protocols, GCPs and SOPs, verify the validity of the data and prepare them for further statistical analysis and clinical report.
• Ensure the timing of reporting of serious adverse experiences to GSK Bio, in strict accordance with GSK Bio’s Standard Operating Procedures.
• Assist in audits of clinical operations.
• Provide medical and scientific input and information, as well as pre-approval of marketing material for new products
• Take part in scientific activities, attend clinical working groups and take part in international project teams.

Achievements (GSK Biologicals):

• Set up of the Romanian Vaccine Advisory Board, a workgroup of multiple specialties KOLs to improve the vaccination policies and practices in Romania. In 2007, this body became the Consultative Commission of Ministry of Health.
• Developed & wrote a study Protocol (GSK Bio approved) and implemented a surveillance epidemiological study to collect national data on Haemophilus influenzae type b meningitis in children 0-5 years of age, obtain and store bacterial isolates of Neisseria meningitidis and Streptococcus pneumoniae for further laboratory identification tests.
• Developed a network of investigators for GSK vaccines clinical trials. Implemented 2 international, multi centres, randomized, blinded clinical trials in Romania. Study 208141, under IND, investigates safety of a candidate HSV2 vaccine in adolescent girls – revised target reached, study ends next year. Study 100388 assessed immunogenicity, long term protection and safety of 1 dose varicella vaccine compared to 2 doses MMRV, in children 12-24 months of age – ongoing, entering the 2nd year of the 10 years follow-up.
• Lectures for vaccinology, value of vaccines and modern combination vaccines, at National Congresses or Scientific sessions of Romanian Societies of Paediatrics, Family Medicine and GPs.
• Trained the Medical Representatives toward a scientific approach of discussions with HCPs on vaccines topics. The high level of knowledge, supporting their strict ethical promotional activities, ensured doctors’ recognition of GSK as “the” partner of choice for medical information &scientific dialogue.
• Established an excellent communication with external (PH specialists, epidemiologists) and internal (Reps, BM vaccines, etc) customers, based on solid professional knowledge, a sound view of vaccinology aspects in the local / regional context and a good networking with Public Health specialists & decision makers.

Main responsibilities and achievements:

• Developed a public health department - designing it, choosing necessary equipment, laboratory tools and reagents, finding specialized trained personnel, supervising 19 team workers.
• Managed systematic public heath objectives.
• Coordinated vaccination campaign against viral hepatitis B (all medical personnel from the military medical units) – in 1995 – 1996.
• Implemented yearly influenza prophylaxis program in a large population.
• Promoted health through education of population risk groups, increasing awareness of health issues.
• Fieldwork – in outbreaks of cholera, foodborne infections.
• Laboratory work – serological studies of HBV, HCV and HIV prevalence in a large population.

• Medical consultant for private projects of two clinical laboratories, a polyclinic and a hospital

• Taught and trained students in infectious disease studies, classes of 20 scholars, aged 16 to 22

Main responsibilities and achievements:

• Practical epidemiology – responsible to control vaccinations included in National Immunization Plan, in paediatric dispensaries; teamwork vaccination against influenza of a large mass of people, at “Aversa” factory, increasing awareness of that population on medical aspects.
• Clinical experience – responsible of a 10-bed ward for 8 months; numerous on-duty days at Colentina Infectious Diseases Hospital.

• Assisted reputed specialists in infectious diseases field – Prof. Dr. Mircea Angelescu, Prof. Dr. Ileana Rebedea, gaining solid clinical skills