Project Management Clinical

Curriculum Vitae

Valery V. Novikov, M.D., Ph.D.

**, *** *******

***** ********-***-*****

France

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

Mobile: +33 6 38 47 30 62

http://ru.linkedin.com/in/novikovvalery

Medical director and director of clinical operations and project management with 20+ years of experience.

Proven experience in setting up the clinical/project/regulatory management in companies haven’t had it before. Successful further leading for many years. Raise of teams from 10 to 100+ employees.

Project management across the globe.

Leadership and motivation of multifunctional and multicultural team.

Clinical experience encompasses both large and small molecules: monoclonal antibodies, enzymes, proteins for oncology, hematology, rare diseases, respiratory, neurology and others.

With an extensive leadership and management skills in planning & executing clinical development plans and studies within Oncology, Rare diseases and other Therapeutic Areas, I possess a demonstrated track record of translating senior level research / scientific business requirements into operational strategies globally.

Setting up and continuous KPI delivering for project management, clinical operations and regulatory.

Writing and review of clinical part of submission packages for IND/NDA/BLA (US) and for submission in EU. Guiding the scientific advisory boards, meetings with KOLs.

Critical and analytical thinking, close attention to details, proactive planning, excellent management and leadership skills.

Excellent GCP/ICH background, experience in EMA and FDA regulatory requirements.

7 years in practical medicine (hematology and oncology).

References may be found in the end of this document.

Work History

Clinical Study Director

Sanofi/Alios, Paris, France July 2017 – present

Early phase project leading.

Global clinical project manager

AB science, Paris, France Feb 2017 – June 2017

Management of global project (oncology, neurology).

Full accountability for projects’ deliverables: timelines, budget, quality, CRO management.

Medical director and General Director Deputy in clinical research (VP R&D)

Generium (Group of companies), Moscow, Russia March 2015 – Dec 2016

Medical direction to clinical studies of monoclonal antibodies and proteins in Oncology (Rare Diseases, Hematology, Respiratory) and contributing towards execution of company’s clinical development programs spanning drug development plan and protocols writing until final report and state authority’s registration in several countries.

Leading medical department teams across 18 projects at present along with continuously educating team in project specific topics.

Analysis and interpretation of clinical trial data and reporting of clinical trial results. Clinical support to the management team in its communications with the Board of Directors, investors, and potential business partners. Along with engaging in scientific interactions, fostering the fruitful relationships with opinion leaders.

Review the current trials consisting DM data, protocol deviations, and basic KPIs such as sites activation, patients’ recruitment and timelines. In order to ensure the overall performance is in line with expectations.

Writing, review and scientific input in packages for IND/NDA/BLA submissions in US and regulatory submissions in EU. Full responsibility for clinical study reports, summary of clinical efficacy, clinical safety and clinical overview. Participation in scientific advisory boards within pre-submission in EU and in US.

Medical monitoring: setup, guidance and supervision.

Some of the highlights of this role include:

Effectively led and grew the team from 7 to 50+ persons in <1 year serving in various clinical trials conduct including data management, medical writing, statistical, full clinical operations team, QA, etc.

Project management and supervise on project management. Regular holistic review of current trials inclusive review of DM data, protocol deviations, basic KPIs (sites activation, patients’ recruitment and timelines). Ensuring appropriate quality management, handling of audit findings, CAPA management.

Accountability for clinical part of eCTD for submission: writing and review of clinical part of dossiers.

Risk management plan.

Gained success in securing recruitment and timelines through effective selection of sites for clinical trials that under risk due to time constrains.

Identification of optimal regulatory strategy outline.

Budgeting: setup and adherence

Close collaboration with preclinical research to ensure the preclinical profile fits to regulatory requirements (EMA, FDA, local) and needs of specific study.

QA supervising, audit attendance

PV supervising

CAPA supervising in all projects and department processes

Control and leading the outsourced work in other countries (e.g. India, Romania) for clinical research and vendors (warehousing, courier etc.).

Supervising of vendors: central lab, central warehouse and central image review.

Implementation of sophisticated software to ensure high quality and higher productivity work (eTMF, eDC, CTMS).

Achievements

Set of procedural documents is created and successfully audited.

Sponsor’s (partnering company) audit with no findings has passed.

Established collaborative relations to patients’ organization (rare diseases).

Budgeting of clinical trials is established, having it controllable and manageable. There is available budget for department and individual trials.

Establish continuous education of team in project specific topics, in therapeutic areas and in common findings and mistake happened during routine work.

18 projects (antibodies, proteins, coagulation factors) are in work in different stages (oncology, rare diseases, infection disease; phases I – IV). Local CROs in engaged for international trial in other countries.

Systematization of procedures for clinical trials programs and protocols writing, inclusive end-points set, population set and size of target population over involvement internal expertise, external experts and KOLs.

Thorough review or audit of outsourced CRO and vendors have been made for their competence, adherence to GCP, other standards and budget adequacy. Work with some of them was finished; total budget was reduced.

Submission of cases for science advice and orphan status to EMA.

Director of operations

Helios Clinical Research ltd December 2013 – February 2015

Oversaw the protocol development and ensured timely development of other core clinical trial documentation.

Consulting in regulatory requirements and clinical trials designing, registration submissions in Russia, Ukraine, EU and US.

Writing and review of: clinical study overview and summary, review of clinical study reports.

Preparation of documentation for IND, NDA and BLA for clients (clinical trials summary and overview). Taking part in pre-IND meeting (US) and scientific advisory meeting in EU.

Risk management plan development (clinical part) (RMP).

Medical monitoring.

Achievements

LE and full set of SOPs were created for new company.

Consulting of several external clients.

Successful creation of IND, NDA and BLA packages. Effective collaboration with sponsor’s team in getting them ready for authority meetings. Participation in pre-IND meeting.

Senior Director of Clinical Operations

PRA International, Russia October 2003 - March 2013

Led a clinical operations team and multifunctional teams across Russia, Ukraine, Belarus, Kazakhstan and Georgia with focus on regulatory and safety submission, Study start up, critical milestones setup, observation of timely deliverables, critical issues handling in several countries of region, Clinical Monitoring, and much more.

I established performance, quality, customer service, and business efficiency and innovation metrics for the clinical sites; addressed systematic deficiencies and improved quality in selected investigational sites.

Other responsibilities in this role included: reviewing documents required for clinical trials, hiring and training of clinical operations staff and administrative staff, budgeting, P&L management & expenses control, vendor management and quality assurance.

I represented the region in central proposal input and bid defense and acted as legal representative in Russia, Ukraine and in Georgia and supported and facilitated QA, sponsor.

Some of the highlights of this role include:

Led continuous growth of business and headcount over the years: grew team size till 100+ employees across several countries of the assigned region.

Reviewed documents required for clinical trials: protocols, PIC, hand-outs, regulatory submission docs.

Collaborated with health authorities in Russia and Ukraine.

Supported and facilitated QA, sponsor, HAs and independent entities during audits

Resources management: timely identification of resources need, allocation of resources into projects; Adequate staff utilization control and assurance

Training, coaching and managing of managers

Budget and P&L: setup and management, expenses control

Vendor selection, assessment and hiring

Achievements

Setting up and effective management the regulatory, managing and clinical operations team for 10 years.

Continuous grow of business and headcount over the years: team had grown till 100+ employees in several countries of region.

Keeping the targeted KPIs.

No critical findings in audits.

Head of Moscow representation, Lead of project management and clinical operations

VALID-TRIO GmbH, Russia June 2000 - October 2003

Project management and leading the clinical operations in Russia, Ukraine and Byelorussia including: supervision of submission and approval processes to health authorities, importation and exportation of study drug, materials and biological samples; direction of feasibility studies; selection, evaluation and qualification of new trial centers; planning of site visits by CRAs, monitoring.

Preparation and review of project documents (study protocol, PIC, hand-outs, regulatory submissions).

P&L of operations and of company, expenses control.

Negotiation of agreement with hospitals and investigators.

Supervision on SOP, GCP/ICH and local regulations fulfillment; training of new CRAs;

Financial planning for business unit and company;

Business development: contact to clients, study and study budget planning, pass-through costs estimation; negotiation of agreements with client.

Achievements

Company was established from scratch; in 1,5 years company did have operations in Russia, Ukraine and in Belarus being able to provide all kind of regulatory submissions and monitoring of sites. Several new clients were attracted

Team able to perform project management, QA, regulatory affairs, logistic and site monitoring was hired, trained and grown up.

In 3 years (2003) company did have robust regulatory and operational staff. That become a good asset to be acquired by global CRO (top ten) as a base for regional operations

Deputy of head of representation, senior CRA

CONET GmbH, Russia, Germany January 1999 - May 2000

Clinical Research Associate (part time)

Boehringer Mannheim, Russia 1994-1998

Doctor

Blokhin Cancer Research Center, Moscow, Russia 1993 – 1998

Education

Ph. D. 1994 – 1998

Blokhin Cancer Research Center, Moscow, Russia

Title of thesis: “1st and 2nd phase of clinical research of human recombinant interleukin-1 beta (Betaleukin) in cancer patients”

Residency 1991 – 1993

Science research institution of Hematology and Transfusiology, Moscow

Postgraduate course of Hematology and Transfusiology

Hematological diseases (Hodgkin and non-Hodgkin lymphomas, leucosis, mielodepressive syndromes etc)

M.D. 1985 – 1991

Sechenov Moscow Medical Academy, Medical Faculty

Languages

English Fluent

Russian Native

French Pre-intermediate

References

Ludger Lunger Mobile: +49-176-**-**-**-** e-mail: *************@***.**

Direct supervisor (VP) in PRA Head Clinical Research at GlaxoSmithKline GmbH&Co (currently)

Friedrich Kursten Mobile: +43-664-*****-** e-mail: *********.*******@**********.***

Vice President, Octapharma

Anna Filimonova, MD, PhD Mobile: +7 985-***-**** ****.**********@*******.***

Associate Director Clinical Operations GMBA PAREXEL International (RUS) LLC

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