Менеджер по взаимодействию с профессиональным сообществом/ Медицинский советник( Валента Фармацевтика )

Описание

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Jan Komlev
Petersburg, RU • +7 921 9 569276
jankomlev@gmail.com • LinkedIn
Personal Details:
Date of birth : 02/10/1978 ▪ Place of
birth : Petersburg, RU ▪ N ationality :
Russian ▪ C ivil status : Married
Accomplished leader with solid experience directing clinical and administrative operations of pharma and CRO .
Proven success providing medical assistance to managed care, health economics , and outcomes research working groups .
Expert at collaborating with Clinical operations and ClinDev team s to develop and share medical resources as well as plan
congresses. Known for leading development of me dical procedures and technology . Skilled at delivering services as technical
expert for therapeutic and product training for MSLs teams to up date scientific knowledge. Track record of building and
managing professional relationships with stakeholders and cross -functional department s to achieve key business objectives .
Excel at assessing performance of company and products.
Areas of Expertise
• Clinical Operations Management
• Strategic Planning & Execution
• Team Leadership & Direction
• Cross -functional Collaboration
• Events Management
• Contract Negotiations
• Medical Research & Analysis
• Reporting & Documentation
• Process Improvements
Career Experience
Arena Pharmaceuticals /Pfizer (via Amplity Health) , Central European Time Zone Feb 20 22 – Aug 2022
Physician Scientist Clinical Development Belgium /Germany /Netherlands/Spain/Switzerland

In my role I was responsible to support the scientific two -sided communication with the investigators in the phase II of the
clinical trial of the ongoing study S1P receptors’ modulator for Eosinophilic Esophagitis . Build and maintain scientific alliances,
specifically with regional and global KOLs. Engage cross -functional partnership with Cl inical operations, Medical Monitors, and
vendors (CRO) teams. Impart specific project -related knowledge in response to peculiar unsolicited medical questions in
regard to the eligibility criteria addressed by Medical Monitors and Investigators' teams. Faci litate scientific exchange between
the academic community and Arena Pharmaceuticals , review Protocol deviations log and medical monitoring plan and write
adverse events of special interest narratives. Work jointly with the clinical team to smoothly attain the patients' enrolment in
the estimated deadlines.


Arena Pharmaceuticals (via Amplity Health) , Petersburg, RU Sep 2019 – Dec 2021
International Medical Science Liaison Russia/Estonia /Bulgaria
Deliver investigational product and organizational pipeline. Determine and collaborate with International Key Opinion Leaders
for desi gnated therapeutic areas, i ncl ud ing IBD: Ulcerat ive Colitis and C rohn’s disease. Build and maintain scientific alliances.
Contri bute in IBD International/ National congresses, investigational meetings, conferences, scientific events , and webinars.
Continuously updаtеmedical and scientific understanding, such as IBD. Cooperate in overall functions of company, medical
education, and advisory boards . Provide information in response to specific question of healthcare professional s.
• Assist ed in phase II and III clinical trials of S1P receptors’ modulator through identification of appropriate sites and
interaction with investigators in ongoing studies by cross -functional partnership with Clinical Development, Clinical
operations, and vendors (CRO) teams.
• Conducted and oversaw scientific and investigational meetings and educational events.
• Facilitated in patients enrolment in clinical trials within estimated deadline.
• Developed and implemented site engagement medical plan s and strategies .
• Led referral network by contributing to enrolment for meeting tight timelines.
• Organized on boards training sessions for new MSL’s team members .

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MedTransService , Petersburg, RU Dec 2014 – Sep 2019
Freelance CRM/Clinical Trials Liaison
Steered multiple activities, like HCP/KOL comm unication, recruitment support, issue termination , and scientific study support.
Provided feasibility services and support to minimize risk s. Negotiated c ontract and budget for assigned studies.
• Led regulatory/Ethics interactions for seamless operations.
• Performed QA and assistance functions for sponsors, covering CRO and vendor management.
Virpharm , Petersburg, R U Apr 2009 – Dec 2014
Freelance CRA
Managed protocol and project as well as supported in preparing monitoring plans by acting as lead monitor . Assessed needs,
resources , and timelines through cooperation with internal work groups . Served as contact for clinical trial supplies and other
suppl iers, like vendors. Directed all aspects of study site monitoring , covering routine monitoring and close -out of clinical sites,
maintenance of study files, conduct of pre -study , initiation visits, and communication with vendors . Supervised completion of
various process es, including Serious Advers e Event (SAE) reporting, productio n of reports, narratives , and follow up of SAEs.
• Attained target ed objectives by reviewing progress of projects and initiating appropriate actions .
• Supported in training, mentoring, and development of new staff members .
• Independently performed CRF review as well as query generation and resolution regarding established data review
guidelines on client data management systems.
Additional Experience
Clinical Research Associate , Quintiles St. Petersburg, Russia
Pulmonologist /Research Fellow , St. Petersburg City Hospital #26, Department of Pulmonology, MD
Education
Medical Doctor
Pavlov State Medical University of St. Petersburg, Petersburg , RU
Postgraduate (Internship in Internal medicine & allergology, Department of Internal Medicine & Clinical Pharmacology)
St. Petersburg Medical Academy of postgraduate Education , Pete rsburg, RU
Therapeutic Experience
Oncology: Breast Cancer | Endocr inology: Diabetes, Dyslipidaemia | Gastroenterology: IBD (Ulcerative colitis & Cro hn’s
disease) and Eosinophilic Esophagitis | Pulmonology: Bronchial Asthma, COPD | Dermatology: Psoriasis , Atopic dermatitis |
Rheumatology | Cardiology
Language s
Russian (Native) | English (Fluent) | Italian (Basic)
Training
Basic CRA Training (Including Training in GCP & Company Sops), Quintiles
Project Specific Training, EDC Training, Central Vendors’ Data Handling Training, IV (W) RS Trainings, Medical Training in
Project -Specific Fields
MSL Training: Building Successful Relationship & Trust Through Emotional Intelligence, Evolving Strategy Through Actionable
Medical Insights, Impactful Multichannel Stakeholders Engagement, Presenting & Facilitating with Impact, Sc ientific
Engagement Model, The Role o f MSL : Bringing Science to Life, Competitive Product Presentation. Projects Specific, GCP’s &
Country’s Codes Training