Medical Management

Location:

Saratoga, CA, 95070

Posted:

August 29, 2011

Contact this candidate

Resume:

EDWARD GOLDBERG, M.D.

Stryker Corporation

Fremont, California USA

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

_______________________________________________________________________

Medical Director

Boston Scientific/Stryker Corporation

Neurovascular

Fremont, CA

2009-present

Senior staff and management board position.

Major roles

. Director of Medical Affairs with 3 direct reports

. Clinical Trial Medical Monitor

. Post-Market Safety Surveillance

. Risk Management

. Lead clinical communication with the FDA

. Participate in new business development

Director of Medical Affairs:

. Post-Market Safety Surveillance (Review of MDRs and complaint trends)

. Risk Management Assessment (Development of Clinical Experience

Summaries, FMEAs, etc)

. Medical monitoring of clinical trials

. Development of trial protocols and case report forms

. Assessment of investigator sponsored research

. Evaluation of marketing material

. Collaboration with KOLs with respect to presentations and

publications

Clinical Trials:

. Medical monitor of clinical trials which focus on treatment options

for ischemic and hemorrhagic stroke

. Safety reporting to international regulatory authorities regarding

adverse events occurring in sponsored clinical trials

. Assessment of Investigator Sponsored Research (ISR) submitted to

internal Research and Education grant committee

. Lead clinical discussions with the FDA regarding protocol design for

PMA submissions.

Post-Market Safety Surveillance

. Analyze and interpret aggregate data and individual adverse event

reports

. Escalate complaints unanticipated in nature or severity

. Medical review of MDRs and complaint trends

. Health Hazard Assessment of potential Field Actions

. Review of customer notification letters

. Complaint Management Board Review

Risk Management:

. Development of Clinical Experience Summaries compliant with MEDDEV

2.7.1

. The clinical summaries serve to:

o Evaluate the safety and performance of devices based on intended

use

o Identify harms for input into the risk analysis process (FMEAs,

DFU) to fulfill ISO 14971 requirements

o Allow for regulatory approval of products in the EU

. Cross functional collaboration in the design and development of FMEAs

and DFUs

Regulatory Approvals:

. Supported US approvals for the Neuroform EZ stent system, Target

Coil, and In Zone device

. Supported Taiwanese FDA approval of the Gateway Balloon and Wingspan

Stent Systems

Device design and development:

. Senior staff member of the Project Investment Board (PIB) and

Business Planning Team (BPT), which oversee product development

decisions and milestones

. Independent reviewer of R&D bench testing protocols and development

strategies

Therapeutic areas

. Hemorrhagic stroke and intracranial aneurysms

. Acute ischemic stroke

. Intracranial atherosclerotic disease

. General intracranial endovascular treatment (AVM's, thromboses, etc.)

PHYSICIAN WORK EXPERIENCE

Applicable Skills:

. Board certified neurologist.

. Technical knowledge across broad spectrum of therapeutic areas

. Decision making expertise/strategies

. Influence management and physician collaboration

. Leadership abilities and team building

. Ethical principles and leadership

Private Practice

Neurologist, Clinical Director

Columbus, Ohio

2007-2009

Beth Israel Deaconess Medical Center

Neurologist

Boston, MA

2006-2007

Boston Medical Center

Neurologist

Boston, MA

2003-2006

PUBLICATIONS

SPS Syndrome

Goldberg, E.

5-Minute Clinical Consult chapter

Neurology

CLINICAL RESEARCH

Intracranial Atherosclerotic Disease

Stenting of intracranial atherosclerotic stenosis

S.A.M.M.P.R.I.S. (Stenting & Aggressive Medical Management for Preventing

Recurrent Stroke in Intracranial Stenosis)