Medical Manager

Описание


Vyacheslav V. Lukyanchikov, M.D.
+7 (903) 269-19-29
lukyanv@gmail.com
Date / Place of Birth
June 22, 1968; Moscow, Russia.
Marital status
Married, two children
Education:
Higher, Medical
1985 -1993
Moscow Medical Stomatology Institute
Moscow, Russia - MD, General Therapy
Post-diploma:

1993 - 1994
Russian Clinical and Experimental Immunology Research Institute, Moscow, Russia - Clinical Immuno-Endocrinology - MD.
Postgraduate training in Clinical Endocrinology.
SUMMARY:
Twenty years of a Clinical Research and Medical Affairs experience (International, local CROs and Pharmaceutical companies) in various positions starting from CRA through Head of R&D, Medical Manager and Medical Director. Experienced in Clinical Documentation preparation and Site Management as well as OL and professional societies collaboration, organisation and conduct of scientific events and Advisory Boards. Very good working contacts with Russian opinion leaders, Clinics, and Regulatory Authorities.
Personally developed 20+ clinical and observational studies' protocols and accompanying documentation.

Therapeutic Area Experience (as a Clinical and Medical Affairs person):
Endocrinology, Oncology, Haematology, Neurology, Pulmonology, General Therapy, Gastroenterology, Cardiology, HIV and Infectious Diseases, Paediatrics, Rheumatology, Angiology and Phlebology, Urology, Gynaecology, Intensive care, Ophthalmology etc.)

Experienced in the development of SOPs, WP and WI documents.
Audit and co-audit clinical sites and CROs in regards to general GCP and study protocol requirements.
Co-auditor in GMP Audit (Selection of the third party manufacturing site).

MD with five years of clinical medicine experience. Specialty - General Therapy, Endocrinology, Ultrasound Imaging.

Employment Records:
Jun-2019- today
"Sintez" OAO - Russian Pharmaceutical Company
R&D Director
Scope of Responsibilities:
Pharmaceutical formulation and development of the company's products;
Pre-clinical research;
Clinical Phase I-III and Bioequivalence trials organisation and conduct;
Pharmacovigilance activities;
State registration of the company's products in RF and abroad
Medical Affairs
Governmental Relations
Mar-2016 - Jan-2019 (termination of the company activities)
RD1, LLC (Local Contract Research Organization)
R&D Director
RD1 LLC is a Russian Local Contract Research Organization providing services that extend from new drug formulation trough-out preclinical and clinical development to drug registration and its inclusion into reimbursement programs.

Scope of Activities & Therapeutic areas:
Preclinical Research (Psychiatry, Multiple sclerosis)
Clinical Trials (Neurology, Gastroenterology, Rheumatology, Angiology, Cardiology)
Observational Trials (Neurology, Gastroenterology, Paediatrics, Ophthalmology, General Surgery, Endocrinology, Gynaecology)
Bioequivalence.
Scope of Responsibilities:
Customer Relations Development and Maintenance
Governmental Relations
Clinical Trial Planning and Supervision, including maintenance of the Site contacts;
Clinical Research and Regulatory Affairs Staff management
Maintenance of Quality Standards of the company performance (no critical observations during sponsors' audits)
Control of the Goals' achievement

Nov-2013 - Jan-2016
Alfa Wassermann
Medical Affairs Manager
Scope of Responsibilities:
Establishing working relationships with country OLs:
Development of local publication policy,
Setting up specialized Advisory Boards,
Organization of company sponsored symposia within local and international Conferences
Local and international Clinical Research Activities

Mar-2013 - Oct-2013
Medisy LLC.
Managing Director
Scope of Responsibilities:
State registration of the Company's own Medical Diagnostic Equipment
Initial Promotion & Governmental Relations
Jun-2011 - Dec-2012
Bausch & Lomb
Medical Manager
Feb-2010 - May-2011
Maxwell Biotech Venture Fund
Managing Director with responsibilities for preclinical and clinical development
Scope of Responsibilities:
Development of strategic partnerships between the fund's portfolio companies and other inMedternational companies as well as external financing sources, negotiation of the terms and structure of the fund's investments, overseeing the management of all portfolio company investments, and due diligence on all potential investments.
Apr 2004 - Jan 2010
Abbott Laboratories
Acting Medical Director (2008-2010)
Duties and responsibilities:
Clinical Research
Supervision of Clinical research activities, Initiation & conduct of Phase II-IV clinical trials, and post-marketing observational projects. Budget and CRO management.
Medical Affairs:
Review & approval of promotional materials and local scientific publications; Preparation, review and approval of local clinical studies, Maintenance of well established relationships and interactions with national Opinion Leaders, Medical Information co-ordination & field force training. Representation of company interests in Regulatory Authorities.
Pharmacovigilance:
Clinical and spontaneous Safety surveillance / reporting / training.
Quality Assurance
GCP and GMP compliance check

Jan-2001 - Mar-2004
Pfizer International Inc.,
Manager for Clinical Research (2002-2004)
Type of employees:
Clinical Trial Managers, Clinical Research Associates.
Scope of Responsibilities
Clinical research (planning, conduct and supervision of phase II-IV studies and IMGs); Review and Approval of Local Clinical Study proposals; Investigators education; Management of CRA performance, Clinical Supplies Co-ordination; Regulatory approval, Safety surveillance/reporting; Training.

Clinical Research Associate (2001-2002)
Scope of Responsibilities:
Monitoring of clinical Trial, drug supplies co-ordination, Safety reporting in Clinical Trial
Jan-1997 - Dec-2000
Omnicare Clinical Research
Clinical Research Associate
Scope of Responsibilities:
Monitoring of clinical Trial, drug supplies co-ordination, Safety reporting in Clinical Trial
Jun-1992 - Jan-1997
Russian Clinical and Experimental Immunology Research Institute, Moscow, Russia.
Language knowledge:
English - fluent
Important notice:
I understand that the position I am applying for is less senior that I had in my previous experience. I agree with this and would like to assure that this is not going to have any negative impact to my potential performance but will give an additional chance to implement my experience in a new position.