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Medical Manager

Location:
San Diego, California, United States
Posted:
May 22, 2018

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Resume:

Michele Stegmaier

SUMMARY:

Experienced Medical Science Liaison and passionate researcher of treatment options for improved patient outcomes focused on personalized medicine and targeted therapy. Research experience in monoclonal antibodies, genetics and stem cells. Looking to leverage strategic development and global expertise with in-depth knowledge of Clinical Research, Immuno-Oncology and the Biotech industry. Clinical Trials, Medical Affairs and R&D expertise across multiple therapeutic areas. Domestic and International experience with client focused success. Medical Monitor for multiple studies and all A&E reporting. Experienced manager of medical documents and publications. Solid and diverse background within the medical industry. A highly committed and service-oriented professional who has conducted key Advisory Boards with global thought leaders. An energetic problem solver with proven managerial and leadership skills. Excellent at developing and maintaining relationships with C-Suite executives, physicians, and KOL’s.

PROFESSIONAL EXPERIENCE:

Consulting- San Diego, CA November 2016- Current

Fate Therapeutics- Director NK100 cells

Confidential- Various Clinical Research

Fisher & Paykel-Respiratory Research

Transgenomic-Genetic and Diagnostic Research

Immuno-Oncology, Bristol Myers-Squibb- Princeton, NJ January 2015- October 2016

Worldwide Medical Director

Lead clinical and strategic direction for global Immuno-Oncology Lung, GBM, Biomarker

Project Manager, Medical monitor, operations and protocol management.

Responsible for Developing and Executing the IO Expanded Access Programs (NPP, CUP, etc.…) Includes all A&E reporting

Provide IO medical/scientific guidance to clinical product and disease area teams

Medical Monitor for Opdivo Lung studies, including oversight of Safety.

Contributor to clinical development plans across various tumor types

Lead Biomarker strategy for PD-L1, and future biomarker pipeline

Write and prepare high-level documents for the Medical Review Group, Publications and regulatory communications.

Collaborate with internal and external resources to identify opportunities and to optimize translational and clinical strategies.

Development and Presentation at all major symposiums, conferences and advisory board meetings.

Drive medical strategy globally and oversee competitive intelligence.

AstraZeneca Immuno-Oncology- Gaithersburg, MD February 2014-December 2014

Medical Director

Accountable to MSD and iMED leadership team, for MEDI4736 program (monoclonal antibody)

Responsible for late stage clinical study design and clinical strategic input

Provide medical/scientific guidance to clinical product and disease area teams

Contributor to clinical development plans

Assessment of overall benefit/risk of products

Prepare medical components of high-level documents for IND, Clinical Study protocols, and regulatory communications

Collaborate with internal and external resources to identify opportunities and to optimize translational and clinical strategies.

Development of iMED clinical plan refinement

Clinical Research, National Institutes of Health- Bethesda, MD October 2010-January 2014

Medical Director

Manage new business development and associated annual budget for CTDB

Oversight and management for clinical trials Phase I, II, III and IV

Manage clinical trials for compliance and safety, in accordance with GCP and FDA

Responsible for oversight of more than 300 clinical protocols in all clinical areas.

Conduct research for Pheochromacytoma trial under the direction of Dr. Karel Pacak

Principal Researcher for multiple Neuro-Oncology and Immuno-Oncology clinical trials

Train physicians and ancillary hospital staff

Primary liaison between IRB investigative sites and sponsor, and PI’s for clinical protocols.

Oversight of CTDB for both intramural and extramural research

VHA (Vizient) Irving, TX October 2010 to January 2013

Medical Director,

Manager of 22 subject matter experts(SME) for physician preference services

Subject matter expertise includes Oncology, Neurosurgery, and Orthopedics.

National clinical trainer for both internal and external clients in oncology,

Project manager and clinical expert for all VHA/Goodroe Gainsharing Initiatives

Expert on treatment protocols for Oncology: Liquid Tumors, and Solid Tumors.

Promote education on current healthcare trends, such as bundled payments, national speaker

In-Servicing, Operating Room Education and Proctoring in the OR

Responsible for physician/hospital alignment for VHA engagements

C-Suite management and pricing negotiations

Establish protocol for Institutions and help identify supply chain cost savings

Educate physicians and other clinicians on evolving practices and controversial trends

Forge Relationships with Key Opinion Leaders

Salient Surgical Technologies- Portsmouth, NH July 2008 to October 2010

Medical Science Liaison

Top performing Medical Science Liaison

Successfully launched new surgical device to Orthopedic and Neurosurgeons

Teach live porcine and human cadaver surgical labs at Johns Hopkins University Hospital

Integrate into and support R&D on new product initiatives and pipeline

In-Servicing, Operating Room Education and Proctoring in the OR

Conduct Clinical Technology Assessments and Trials, collecting, analyzing, and presenting data.

Forge Relationships with Key Opinion Leaders and conduct clinical assessment trials.

TriPath Imaging- Burlington, NC August 2004 to June 2008

Medical Science Liaison

Specialties’ include OB/GYNs, Oncologists, GYN/ONCs, OR Sales, Surgeons, & Pathologists.

Perform surgical training on medical devices and diagnostic equipment.

Target new and existing Physician, Hospital and Lab accounts to achieve sales goals.

Key account sales include diagnostics for cancer detection and Genetic Testing to NIH

Successfully launch new products and increased territory market share by 123% in 2005.

Successfully work with Lab Partners (Quest, Lab Corp, Digene) to increase territory sales.

Promote products by educating targets on proper usage, indication and collection of specimen.

Consistently ranked above the national average in market share, growth, and key metrics.

Develop creative strategies to sell product value, successfully develop & manage territory.

Successfully trained staff of 9 new field sales representatives.

Watson Pharmaceuticals- Somerset, NJ August 2002 to August 2004

Medical Specialist

Medical educator of KOL’s and internal staff on newly launched and orphan pharmaceuticals.

Successfully launched new products and increased territory market share by 9.5% in 2003.

Promote products by educating targets on proper usage, indication and prescribing of medications.

Consistently ranked above the national average in market share, growth, and performance metrics.

Design and deliver strong presentations to potential customers.

Market recognition for “Best of Class” in Sales/Product Training.

Worked directly with Corporate Account Manager to successfully obtain formulary status

American Diabetes Association- Alexandria, VA December 1999 to August 2002

Associate Director

Managed ADA design and message to increase reach and recurring revenues.

Defined potential customers through medical education and targeting.

Directed the marketing, creation and development of ADA products for medical professionals.

Accounts contribute 30% of monthly revenue, achieving record sales revenue three years consecutively.

Managed the ADA website and increased generated sales revenue by more than 20%.

Certified Diabetes Educator

EDUCATION:

MBA, Medical, Frostburg State University, Frostburg, MD 1991

BS, Business Administration, Frostburg State University, Frostburg, MD 1989

MS Biology West Virginia University, Morgantown, WV 1987

CNA, Nursing, CT Business Institute, New Haven, CT 1996

Information Technology Professional Certification, UVA, Falls Church, VA 1997

Lean Six Sigma, Black Belt 2010

CITI cGMP Certified, 2017

ACLS, current

BLS, current



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