Medical Manager

Title:TALIA BIRAN

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

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Name: talia biran

Address: 21` windfall lane

City: marlboro

State: NJ

Zip/Postal Code: 07746

Country:

E-mail: *****.*****@*****.***

Primary Phone: 732-***-****

Background

Most Recent Job Title: Clinical Science Liaison

Most Recent Employer: Merck & Co Inc.

Career Level: Manager, Director Level

Availability or Timeframe: Immediately

Authorized to work in the US: Yes

Security Clearance:

Do you have transportation: Yes

Over 18: Yes

Education: Masters

Languages Spoken: English, German, Hebrew

Job Preferences

Desired Salary: Open

Willing to Relocate:

Desired Job Titles: Sr. Medical Science Liaison

Director of Medical Affairs-Clincal Trials

Director of Scientific communications

Desired Job Types

:

Work Status: Full Time

Desired Shifts:

Desired Travel: 25%

Category: Health Care Management, Marketing, Operations, Project Management,

Sales/Business Development, Teaching/Training

Company Size:

Company Type:

Industry: Banking / Finance, Biotechnology, Pharmaceuticals

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Copyright c 1997- Lee Hecht Harrison, Inc.

TALIA BIRAN

21 Windfall Lane

Marlboro, NJ 07746

Home: 732-***-****

*****.*****@*****.*** Cell: 732-***-****

SUMMARY

Dynamic, innovative and scientific-driven gobal medical affairs/clinical development

pharmaceutical leader who incorporates in-depth understanding of drug development,

therapeutic scientific knowledge, market needs and stakeholder insights to maximize value

across all stages of the brand life cycle. 18 years of diverse experience in global and US

Medical Affairs in large Pharma, specifically in oncology, infectious disease, (HIV, HCV)

and endocrinology. Skilled cross-cultural and cross-functional communicator who leverages

deep scientific and commercial knowledge and brings the clinical perspective to the drug

development process as well as marketing. Specially recognized for ability to foster and

manage world wide collaborations with Key Opinion Leaders in solids tumors and

hematological malignancies. Results driven, creative, and analytical, excelling at

teamwork and customer focus.

AREAS OF EXPERTISE

Scientific and clinical knowledge of Oncology, Infectious disease and Endocrinology.

Knowledge of clinical drug development (Phase I/-IV), GCP/ICH, PhRma, OIG & FDA

guidelines.

Strategic design, implementation and management of global, multi-center Phase I-IV

clinical trials.

Ability to provide leadership and strategic insights into optimizing the

commercialization of brand s equity and medicinal value with focus on Oncology, Infectious

disease and Endo.

Fostering/Developing Relationships with Medical Global Key Opinion Leaders.

Proven abilities to discuss complex clinical data with Key Thought Leaders and Internal

Stakeholders

In depth understanding of NCI and oncology cooperative group structures, decision making

process.

Pipeline Products Scientific Communications, Medical Science Liaison training,

Publication Planning

PROFESSIONAL EXPERIENCE

MERCK & CO INC

., Upper Gwynned, PA 20062010

New Products/Global Customers Insights

Overall medical strategy for Follow-on-Biologics (FOBs) in EU & US-Strategist

Actively participated in various commercial tumor strategy teams(GI, Breast Cancer) and

projects gaining experience with key commercial issues such as forecasting, pricing,

market sizing by tumor type, primary and secondary market research, and life cycle

management as pertains to Merck's oncology new compounds in development.

Lead recommendations for a clinical development strategy for Merck Bioventures (MBV)

follow-on-Biologic, MK-Herceptin compound; Recommendation based on an analysis of

secondary data sources, a review relevant launch analogies, and the completion of primary

market research with global breast cancer KOLs and practicing physicians.

Lead recommendations for developing and compiling the final forecast for Merck

Bioventures (MBV)follow-on-Biologic, MK-Herceptin compound by communicating the POS for

various anti-HER2 competitor compounds such TDM-1, pertuzumab, lapatinib in adjuvant

setting.

External Medical and Scientific Affairs/Global Medical Affairs, NYC, PA, NJ

Oncology Clinical Science Liaison

Established credible scientific-based relationships with key opinion leaders in solid

tumors and hematological malignancies at academic centers and developed strong working

relationships in support of company objectives for hematology oncology business.

Primary conduit for scientific and medical exchange with national investigators and

thought leaders at cooperative group: chairs, task force members, intergroup, ECOG, NCI-

CTEP steering committees.

Provided input to the design of Phase I-IV clinical trials and product life cycle

development.

Managed over 50 Investigator-Initiated Study Programs (Emend and Zolinza), Oncology

Collaborative Study Programs (IGF-1R, mTOR, aurora kinase, AKT, c-met, PARP, Wee-1,

notch), and CTEP collaborations (Zolinza) to include 140 investigators in territory.

TALIA BIRAN

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Home: 732-***-****

*****.*****@*****.*** Cell: 732-***-****

Oncology Clinical Science Liaison, (Continued)

Trained a team of 6 clinical science liaisons on disease state ( i.e.-CRC,BC) and

products in development to optimize the execution of timely, high-quality clinical trials

( from pre-clinical and Phase I-III trials) across several oncology indications. (Solid

and Hem Malignancies).

Served as Clinical Liaison representative on cross-functional team activities with

External Medical and Scientific Affairs, Breast Strategy Team, Publication Teams, MRL pre-

clinical, clinical, and experimental medicine programs, External Scientific Affairs and

Licensing, and Clinical Research Operations.

Lead strategic institutional alliance with Memorial-Sloan Kettering to advance scientific

collaboration in areas of shared interest resulting in leadership site visits and master

clinical trial agreement for Phase I-II clinical trials.

Received AWARD for outstanding performance June 2007 & 2008.

NOVARTIS ONCOLOGY, Florham Park, NJ 20042006Global Medical Affairs

Director

Scientific Communication and Information- Sandostatin LAR

Directed the development and implementation of aligned scientific communication and

publication strategies, tactics and programs in oncology global medical affairs supporting

pipeline and marketed products with~$2 billion in sales.

Ensured awareness of key published data / articles covering breast cancer and colorectal

cancer disease areas, key products, compounds in development and competitive landscape.

Identified, gathered, interpreted, and communicated medical and scientific information

and conference proceedings to global medical advisors and product managers leading to

increased market penetration and expanding the use of the product WW.

Lead the creation of Scientific Information and Communications strategies, tactics and

programs in Oncology Global Medical Affairs supporting marketing of brands with~$2 billion

in sales.

Provided scientific expertise and guidance to the brand teams in the creation of

educational material for pipeline products and in-licensing.

Interfaced closely with marketing for customer initiatives (e.g., PR materials and

programs, sales training manuals, international meetings, CME medical education, internal

communications, satellite symposia, advisory board meetings) and maintained regular

contact with CPOs (countries) to monitor global initiatives.(i.e. country specific

clinical trials, symposiums, Ad boards).

Lead and executed a global Ad board meeting for new indication for Second generation

Somatostatin Analogue differentiating it from Sandostatin LAR.

Provided strategic support to KOL development programs in multiple therapeutic

indications, CME programs, publication planning, and medical education activates during

medical congresses.

Independently developed product and disease state training material and presented to

internal medical liaisons globally for multiple products. Training programs included

disease state (breast, colorectal, ovarian & lung cancer) as well as product information

from preclinical to clinical.

Derived publication planning for the brand and development of medical education material

in accordance with OIG and PharMA guidelines.

Managed the logistics of the scientific booth at large congresses (ASCO, ESMO, ENDO, San

Antonio) in support of KOLs and other Novartis customers.

Clinical Research Manager FEMARA( served as Clinical Trial Leader for Two Global

Trials)

Developed and implemented the strategic plans and oncology clinical affairs activities in

breast cancer (medical affairs and R&D).

Responsible for the preparation and

implementation of Global Company Sponsored Clinical Trials and registries (safety, data

consistency, trial timelines, budget, resources, eligibility, enrollment, vendor selection

and vendor management )

TALIA BIRAN

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Clinical Research Manager

FEMARA, (Continued)

Responsible for the clinical, submission, and approval activities for letrozole in the

adjuvant treatment of breast cancer resulting in Successful worldwide NDA submission

(adjuvant treatment of breast cancer) and worldwide approval.

Lead the development of go/no go decision for the Breast Cancer Prevention program.

Acted as liaison to develop strong working relationships with

COOPS:

EORTC, NASBP, IBCSG

NCCTG to support global oncology drug development.

Co- authored Breast Cancer Guidelines manual for internal medical education.

Developed a Novartis hormonal therapy registry for patients with early breast cancer WW.

Lead multiple IQP (i.e. - Six Sigma) initiatives, highly disciplined processes focused on

developing and delivering near-perfect products, to enhance the processes for Phase IV non-

registration trials.

SCHERING-PLOUGH CORPORATION, Kenilworth, NJ 20022004Oncology Biotech Integrated Therapeutic Group, Inc

.

Regional Manager

- Project Managers- Virology (PJMVs)

Led team of 8 field based HIV/HCV Liaisons in 13 Eastern States.

Acted personally as a liaison to scientific leaders and develop strong working

relationships with experts in therapeutic areas to implement marketing strategies and

ensured delivery of targeted messages via participation in Schering s sponsored and

investigator initiated research (IST) programs.

Develop and implemented team goals and objectives around investigator interactions,

scientific communication strategy, investigator-initiated and virology collaborative study

programs, such as ACTG, annual scientific meetings, COOP meetings, and database tracking.

Successfully developed education strategy and key messaging for region aligned with

strategic imperatives, while maintaining clinical, scientific and technical expertise in

therapeutic area.

Managed team performance, yearly budgets, hiring, and program expansions

Developed and managed team through formal and informal mentoring and coaching

Coordinate team s training and personal development.

HOFFMAN-LaROCHE, Nutley, NJ 1998 2002

Roche Laboratories Medical Affairs

Clinical Study Associate

Hepatitis C Program: Key brand Phase II to Registration

Functioned as clinical trial leader for a 5,000 patients Phase III comparative safety and

efficacy study of Pegylated Interferon in patients infected with Hepatitis C. ( HCV)

Implemented execution of clinical trial: Protocol writing, amendments contract

negotiations, regulatory submissions, site selection, monitoring and closeout activities.

Spearheaded and coordinated the recruitment of 500 investigators into this very large

study by liaising with outside physicians, Roche field Medical Clinical Liaisons and 2

large CROs.

Co-authored and presented interim data publication in AASLD congress 2001

HIV Program

. Managed the Phase IIIb/IV Global/Domestic Marketing Clinical Trials involving Fortovase

for HIV exploring 1. The potential of Protease inhibitors to elicit Immune Reconstitution

in HIV-Infected individuals. 2. The efficacy and safety of Nucleoside analogues in HIV-

Infected Individuals.

o Project lead and coordinate with CRO in overall study planning, management, evaluation

and documentation.( i.e.- clinical study protocols, case report forms, Informed consents,

publications and final study report (CSR) )

o Recruited & managed CROs, Sites and staff of 6 CRAs throughout the study.

. Directed and served as primary conduit for the HIV Roche Laboratories Investigator

Initiated Research program. (IIT)

TALIA BIRAN

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Home: 732-***-****

*****.*****@*****.*** Cell: 732-***-****

THE CANCER INSTITUTE OF NEW JERSEY, UNIVERSITY OF MEDICINE AND

DENTISTRY OF NEW JERSEY

(UMDNJ), Piscataway, NJ 19941997Research Associate

Studied the development of drug resistance in human and murine retroviruses.

Developed a strategy in which modified murine retroviruses can be made to be specifically

toxic to HTLV-1 infected cells.

EDUCATION

Ph.D

Health Sciences, Seton Hall University, East Orange NJ- Candidate, In progress

M.Sc, Microbiology, Tel-Aviv University, Department of Life Sciences,Tel-Aviv, Israel

Thesis: Gene Amplification and Gene Activation by Chemotherapeutic Drugs and Carcinogens,

as a predictive Response to Chemotherapy under direction of Professor Sara Lavi

Master, Science Education, Teaching

Diploma in Science,

Tel-Aviv University,

Tel-Aviv, Israel

B.Sc, Biology,

Tel-Aviv University, Department of Life Sciences, Tel-Aviv, Israel

PUBLICATIONS AND CITATIONS

Reference

Azra Raza, M.D, Director, MDS Program, St. Vincent's Comprehensive Cancer Center:

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