cv

Clinical Research Specialist

Nobel İlaç

Nobel, as a pharmaceutical company, operates with five manufacturing facilities, three in Turkiye and one in Kazakhstan and Uzbekistan, while carrying out promotion and sales activities with its organizations in 20 countries, and through distributors in 30 countries. In my role, I contribute to preclinical and clinical activities, ensuring strict compliance with R&D timelines and product launches. Additionally, I manage responses to regulatory queries and deficiencies for regulatory submissions in over 50 countries. Key achievements include:
- Negotiated contracts with over 10 CROs across Europe, the USA, and India while establishing partnerships with various service vendors.
- Prepared clinical and non-clinical modules (CTD) for more than 30 medicinal products including biosimilars. Conducted preliminary research for more than 25 projects (generics & biosimilars).
- Integrated IMP procurement and regulatory affairs requests into an online platform. Also, Developed RPA software with a vendor to track study timelines, and EC/MoH applications.
- Monitoring visits to two clinical trials and fifteen BE studies in Turkiye. Also, site qualification audits to four sites in Turkiye and six in India.
- Accountable person for organizing pharmacovigilance activities within clinical trials.
- Successfully processed over 30 inquiries and deficiencies from regulatory authorities. Also, assisted in preparing CAPA for a BfArM site audit for a BE project.
- Organized and facilitated four investigator meetings.

• Clinical Trials
• Regulatory Compliance
• Pharmacovigilance
• CRO Management
• HCP Engagement
• Contracts

Business Development Executive

Biocalis

Biocalis is a healthcare company specializing in in-vitro diagnostics, medical devices and pharmaceuticals and leverages a wide distribution network spanning over 25 countries. In my role, I collaborated with an international team and managed accounts in EMEA and Central Asia, coordinating the efforts of our offices in Albania, Azerbaijan, Uzbekistan, and Russia while reporting directly to the managing director. I utilized HubSpot CRM and Excel to analyze performance metrics and track account activities. Key contributions include:
- Conducted market research for a partner (in-vitro diagnostics) to identify potential biomarkers of interest to CDMOs CROs, and other research organizations, followed by lead generation through Springer's AdisInsight subscription.
- Initiated outbound lead generation for PCR Kits during the COVID-19 pandemic, successfully adding new accounts in Croatia, Romania, the UAE, and Pakistan. These accounts also began distributing our other in-vitro diagnostics.
- Identified a critical gap in the Albanian market and proposed adding cefuroxime to our Albanian portfolio to address the demand for secondary bacterial infection prevention in COVID-19 patients. Coordinated its registration process and significantly increased our revenue during the pandemic.
- Found and integrated an AI-powered 3D/4D aesthetic simulation software into our plastic surgery portfolio and supported over 20 plastic surgeons with product training and sales strategies.
- Created and delivered many materials (educational & promotional) to HCPs and patients in Turkiye, enhancing the reach of our Allurion intragastrical balloon to over 3000 patients.

• Regulatory Strategy
• Out-Licensing
• Negotiation
• Market Research
• Lead Generation
• Account Management

Retail Pharmacist

Avaroğlu Pharmacy

I was responsible for coordinating safe and effective medication therapy for patients. Also, I had to adapt the everyday routine of the personnel to conditions caused by the COVID-19 pandemic.

• Patient Counseling
• Polypharmacy Management
• Pharmacy Operations
• COVID-19

Youth Assembly and Assistant Pharmacists Commission Member

Istanbul Chamber of Pharmacists

Our projects focused on the sustainable development goals of the UN and their adaptation to pharmacists in general. I have also volunteered for a week in one of the field pharmacies (Antakya, Turkiye) after the 6 February 2023 earthquakes.

• NGO
• Pharmacy Disaster Management

Youth Delegate

Istanbul Chamber of Pharmacists, Youth Assembly

Youth Delegate IEO Youth Assembly is an autonomous structure where pharmacy students and pharmacists take place and produce together. I had been selected as a delegate in an election that took place in my faculty. I represented my faculty for 2 years and served in many projects. We have organized the first (2018) and the second (2019) pharmacist youth meetings.

• Event Coordination

PhD

Akdeniz University

Gene and Cell Therapy

MSc

Akdeniz University

Medical Biotechnology

• Bioinformatics
• Machine Learning

BSc

Istanbul Medipol University

Pharmacy

Honor Reward

Istanbul Chamber of Pharmacists

I have been awarded for my volunteer work in a field pharmacy after the 6 February 2023 earthquakes.

Local Competition Winner

Seeds for the Future (ICT Talent) - Huawei

As part of Huawei's global Corporate Social Responsibility flagship program; I have been selected for the program in 2022 after several interviews. I have led a team of 10, and we have developed and presented an AI-driven solution to prevent violence toward healthcare workers. We have won the Turkish part in the global competition and participated in the talent summit held in Athens.

In Silico Investigation of Anticancer Properties of Antimicrobial Peptides

CoHE (Dissertation)

A machine learning model—specifically a random forest using amino acid and dipeptide features—was developed to predict anticancer activity in 10,000 antimicrobial peptides (AMPs). The model showed 79.5% accuracy on its validation set, and 1648 peptides demonstrated favorable anticancer properties. Additional analyses included clustering, physicochemical property predictions, and 3D homology modelling. These findings suggest potential dual effects of AMPs in cancer therapy.

Pharmacokinetic Profile and a Bioequivalence Study of Apixaban in Healthy Volunteers

Nobel Medicus

A single-dose, open-label, randomized, two-period cross-over study in 32 healthy male volunteers assessed bioequivalence between a test Apixaban tablet (Nobel İlaç) and the reference product (Eliquis 5 mg). Key pharmacokinetic parameters (Cmax, AUC) were within the CI 80-125%, indicating bioequivalence. No significant adverse events were observed, and the results confirm individual interchangeability of the test and reference products, supporting the test product's use as a valid anticoagulant therapy option.

Enzymatic Targets for Drug Discovery Against Alzheimer's Disease

Bentham Science (Book Chapter)

Alzheimer's Disease (AD) is a neurodegenerative disease. The disease itself is progressive and full recovery from it isn't achievable yet. There are several hypotheses asserted (Cholinergic hypothesis, Amyloid hypothesis etc.) to explain the mechanisms behind the disease. Also, many targets have been identified for possible therapeutics and from these targets, numerous drug candidates have been evaluated in clinical trials. Unfortunately, most of these trials failed due to the enigmatic nature of this disease. Currently, there are 7103 targets associated with Alzheimer's disease listed in the Open Targets platform where 1240 of them are enzyme-related. In this chapter, enzymatic targets of the AD have been reviewed, and those claimed to have disease modifying effects were selected and presented according to their clinical significance.

Models of Spike, Envelope and Membrane Proteins of SARS-CoV-2 Variants for Possible Therapeutics

Journal of Medical Topics and Updates

A study examined five SARS-CoV-2 variants of concern (VoC) by analyzing mutations in the spike, envelope, and membrane proteins. Most mutations were found in the spike protein; the envelope and membrane proteins had only one mutation each in some variants. These findings suggest that targeting the less mutated structural proteins could be useful for future vaccine and drug development.

Antibiotic Susceptibility of Klebsiella pneumoniae Strains Isolated from Clinical Samples

JOTCSA

A retrospective study analyzed 502 Klebsiella pneumoniae strains, revealing rising carbapenem resistance. K. pneumoniae, though part of normal human flora, causes nosocomial infections. Findings suggest escalating resistance, especially in critical care settings, prompting recommendation for stricter antibiotic management policies.

A machine learning model method developed for determining anticancer activity of peptides

Patent Pending.

• Bioinformatics
• Machine Learning

Automation & Digitalization

Developed an online platform integrating IMP procurement and regulatory affairs requests. Built RPA software to track study timelines and manage EC/MoH applications for clinical trials and BE studies.

• RPA
• Clinical Trials
• Regulatory Compliance