Manager Project

OM P. SACHDEV, Ph.D.

* ******* ***** 1-908-***-****

Bridgewater, NJ 08807 ********@*****.***

SUMMARY

Pharmaceutical R&D Operations Leader/Clinical Scientist with comprehensive US and global program

management experience. Strategic thinker, innovative, and resourceful with demonstrated ability to solve

problems. Communicated effectively with both scientific and business information at all levels. Significant

experience in:

• •

Clinical Research/Pharmacology Early/Late-Phase Trials Management

• •

Pre-Clinical Research Post Marketing Safety Surveillance

• •

Product Development/Evaluations Regulatory Affairs/ Quality Assurance

• •

Program/CRO/Vendor Management Mentoring

PROFESSIONAL EXPERIENCE

Invivis Pharma/PharmaLead Therapeutics Bridgewater, NJ AUG 2011 – DEC 2012

Consulting Clinical Research Scientist/Medical Monitor, Solid Tumor Clinical Development at

Celgene Corp. at Basking Ridge, NJ

Support Medical Monitoring Review programs of Legacy Breast Cancer ABI 007 phase 2 studies, and

Phase 3 studies for Pancreatic, malignant Melanoma for the preparation of Clinical Study Reports.

• Collaborate with Project physician for the review of ongoing project summary data including: safety,

primary efficacy variables, and safety laboratory data.

• Review literature and prepare summary documents for inclusion in IB, protocols regulatory

submission documents, etc.

• Lead Clinical Research project teams that include members of Clinical Operations, Data

Management, Statistics, Drug Safety, Regulatory and Project Management.

ENZON PHARMACEUTICALS, INC., Bridgewater, NJ 2006 – 2011

Program Manager/Clinical Scientist, Oncology Clinical Development

Managed financial plans for clinical program/portfolio to track the operational budgets, resources and

timelines for projects against agreed upon goals. Presented program updates/results to Development

Leadership Team and Executive Committee. As Operational Lead, negotiated, approved and managed

contracts with research institutions, external vendors (CROs, CMOs, third party monitoring (cardiac,

Central Laboratories biomarker analysis facilities) services.

• Advanced two clinical programs from Phase 1 to Phase 2 studies and developed clinical plans for

Phase 3 metastatic colorectal (mCRC) and breast (mBC) trials.

• Led Cross Functional Team that developed plans for communication/motivation of global clinical

trial team members.

• Developed study objectives, and maintained project timelines for Early Development cytotoxic and

targeted therapies program in Oncology.

• Directed the development of trial related documents, and prepared key documents e.g. Investigator

Brochures, FDA Briefing Documents, internal or external presentations at national meetings.

• Established and partnered with cross-functional groups for implementation of best practices to bring

efficiencies/consistency across different programs.

• Prepared Clinical Operations reports including Operation, Risk/Contingency and Communication

plans to drive the drug development through third party partners.

• Supervised/Chaired clinical data review meetings consisting of Medical Monitor, PV and data

management groups.

• Led a group that analyzed the clinical safety including lab/biomarker PK/PD, pharmacogenomics

data, as well as primary efficacy variables during execution and upon completion of the trial.

OM P. SACHDEV, Ph.D., M.B.A. Page 2

AMGEN INC., Thousand Oaks, CA 2005 – 2006

Associate Director, Medical Sciences/Clinical Pharmacology - Oncology Early Development

Managed and supervised 10 Clinical Research Managers/Specialists that implemented/executed Clinical

Programs in Oncology therapeutic area.

• Directed and executed Clinical Development programs for oncology targeted therapies.

• Identified resources (FTE, budget, third party vendors) to organize investigator meetings per

regulatory requirements and to initiate/execute the clinical trials, lock-in database for CSR

preparation.

• Provided intellectual insight for the successful product development into experimental design and

data analysis.

NOVARTIS ONCOLOGY, INC., Florham Park, NJ 2003 – 2004

Director, Clinical Research Operations

Led Clinical trial allocations process globally and managed 6 Project Liaison Managers and Clinical

Operations Managers to serve 200 internal associates of Development organization.

• Developed and implemented strategic clinical trial start-up plan. Achieved >25% efficiency in study

start, and implementation of consistent practices across all Country Pharma Organizations.

• Spearheaded efficient Clinical Development Plan approval process with input from global medical

advisors. Gained buy-in from senior leadership to implement improved CDP process.

• Implemented IND Assistant tool to improve efficiency of Annual IND Safety Report filings to FDA.

Eliminated backlog of pending reports.

KYOWA PHARMA, INC., Princeton, NJ 2001 – 2003

Associate Director, Oncology, Urology and CNS Project Management

Directed a staff of 5 Project Managers/Global Trial Managers, and monitored CRO activities. Provided

guidance on oncology protocol related procedures in clinical trial management.

• Managed three Proof of Concept (PoC) clinical programs in oncology and urology that progressed

to phase 2 studies.

• Supervised and successfully concluded (clean database) six global clinical trials (breast, ovarian,

NSCLC, colon and prostate cancer).

• Developed and trained in-house Clinical Research Managers on standard operating procedures

(SOPs) to ensure the quality of CRO work on the company’s behalf.

• Coordinated regulatory IND submissions and IND Annual Safety Reports to meet FDA obligations.

• Developed timelines for Oncology and Urology projects and tracked progress on a continual basis.

Identified and managed both cross-project and cross-functional issues (e.g. toxicology,

pharmacology and CMC) at project and program level, including timeline and budget.

• Created, tracked and implemented global development/clinical development plans. Collaborated

with cross-functional team members/portfolio manager and implemented the strategy of senior

leadership.

JANSSEN RESEARCH FOUNDATION, Titusville, NJ 1995 – 2001

Associate Director, Clinical Pharmacology, Sr. Site Manager/Trial Center Manager

Worked in Team Matrix environment that managed clinical programs. Developed financial/clinical plans to

meet short- and long-term objectives of clinical programs. Managed and tracked the operational budget,

resources and timelines Clinical Pharmacology research.

• Led the initiation/execution and completion of Phase I, & IIIB Clinical Pharmacology studies

including protocol development, site/investigator selection, and administration/implementation of

clinical program including writing of Clinical Study Reports (CSRs).

• Managed global multi-center Phase II, III and IV clinical trials in Gastroenterology (GERD, Post-Op

Ileus, Chronic Constipation, IBS/Crohn’s Disease, Functional Fecal Retention) and Oncology (Solid

tumors and AML). Completed projects on-time, within budget and consistently delivered quality

data.

• Coordinated the development of global recruitment strategies. Implemented contingency

recruitment plans for trials on the critical path

• Conducted multi-center Phase IV (GERD), clinical programs, summarized the clinical report for

regulatory submission on-time, within budget for regulatory submission.

OM P. SACHDEV, Ph.D., M.B.A. Page 3

CHEMEX PHARMACEUTICALS, INC., Ft. Lee, NJ 1992 – 1995

Director, Research & Development

Directed oncology drug development program and managed the phase II, III clinical trial and I programs.

• Prepared clinical submission documents for Health Authorities (HA) and coordinated NDA

filings to achieve approval of Amlexanox®.

• Managed Oncology, Virology and Dermatology projects to develop/manage relationships

with CROs, CMOs and Investigators to foster positive interactions to achieving desired business

outcomes.

• Organized, facilitated and monitored all discovery, development, clinical and regulatory

activities required for the successful product development in anti-infective (viral) and oncology

therapeutic areas.

AMERICAN CYANAMID/ LEDERLE LABS, Pearl River, NY 1984 – 1992

Senior Clinical Research Associates/Scientist – Oncology Group (1988-1992)

Designed/developed Phase I, II and III protocol summaries, final protocols, and case report forms.

• Managed Investigator initiated studies for monoclonal antibodies, cytotoxic and

Photodynamic Therapy (PDT) in oncology.

• Monitored reporting of adverse events, continued surveillance of the safety/efficacy of

oncology products and updated annual IND report submissions.

Project Leader – Analytical Biochemist (1984-1988)

Directed the preparation of protocols/methodology and reports for testing of vaccines and

biopharmaceuticals.

• Developed analytical methods and prepared validation reports to support IND and NDA

filings.

• Represented Quality Management organization at the meetings with FDA.

EDUCATION

M.B.A., International Management, Fairleigh-Dickinson University, NJ

Ph.D., Biochemistry; Minor: Immunology, Howard University, Washington DC

M.Sc., Biochemistry; Minor: Pharmacology, Allahabad University, India

B.Sc., Chemistry with Honors in Organic Chemistry, Allahabad University, India

Project Management Certification, Kaizen Technology, NJ

PATENT

US Patent 08/081,663 - "Treatment of Multidrug Resistant Diseases". June, 1993

PROFESSIONAL ACTIVITIES

The American Society of Clinical Oncology - Member

A.A.P.S. - Secretary/Treasurer, Regulatory Affairs Section

Lederle Science Lecture Committee – Chairman

American College of Clinical Pharmacology - Member

American Institute of Chemists - Fellow-Member, Patent and Copyright Committee

American Men and Women of Science

Who's Who in Science and Engineering in America

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