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Project Management Manager

Location:
Skillman, NJ, 08558
Salary:
negotiable
Posted:
August 07, 2012

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Resume:

SALLY K. WIXSON, V.M.D., M.S., D.A.C.L.A.M., R.A.C.

** *** ***** | Skillman, NJ 08558 | 908-***-**** | w6ex8h@r.postjobfree.com

LABORATORY ANIMAL MEDICINE, INNOVATION & RESEARCH COMPLIANCE FOCUS

Innovative Site Operations | Research Collaboration and Project Management | Risk Mitigation

American College of Laboratory Animal Medicine Diplomate and Regulatory Affairs Certified Professional with a strong record of success ensuring management of animal facility sites, research productivity, innovative programs and ongoing compliance. Formally trained in Project Management. Successfully managed veterinary services, in vivo research support teams, and administration of compliance programs at private research and leading pharmaceutical companies, including J&J, Schering-Plough, and Merck. Complementary skills in grant application and management,

due diligence, toxicology, and clinical trials oversight directly transferable to a healthcare setting.

Strengths include:

Engendering Trust & Scientific Collaboration | Compliance Management & Execution |A.C.L.A.M. Diplomate |

Regulatory Affairs Certified (R.A.C.) | IACUC Productivity| USDA, FDA & AAALAC Interaction |

Staff Training & Development |Collective Bargaining Unit Negotiations | Outsourcing | Budgetary Management & Cost Accounting | Complex Animal Models |Project Management| Biopharmaceutical Innovation |Facility Design and Renovation | Standard Operating Procedures (SOPs)|

LABORATORY ANIMAL MEDICINE & REGULATORY EXPERTISE

• Leadership, Accountability & Staff Training: Serves as a hands-on leader who inspires by example. Maintains accountability for animal welfare, veterinary care, state-of-the-art research study support, and innovative design of curricula for employee training and staff development.

• Compliance Program Implementation & Oversight: Implements research compliance programs and promotes a culture of accountability. Manages compliance activities, including regulatory strategy, compiling reports, SOPs, inspection readiness, USDA, AAALAC & FDA interaction and post approval monitoring. Perpetuates a consistent record of full compliance at all facilities over professional tenure.

• Clinical Medical & Surgical Care: Maintains state-of-the-art veterinary medical, surgical, preventive medicine and health monitoring programs.

• Project Team Accomplishments: Integral member of project teams to develop complex animals models, lead PK staff and meet key timelines and deliverables for preclinical studies. Completed experience and formal training to fulfill requirements to sit for Project Management Professional exam.

PROFESSIONAL EXPERIENCE

MERCK RESEARCH LABORATORIES, Kenilworth, NJ 2009-2011

Senior Director, Laboratory Animal Resources

Developed business critical animal models to determine efficacy and safety of compounds intended for human clinical trials for cardiovascular, infectious diseases, immunology, respiratory and CNS indications, including Parkinson’s and Alzheimer’s programs. Led professional efforts of 55 staff. Managed a budget of $21M with 20% annual cost savings.

• Maintained and monitored regulatory compliance in accordance with USDA, DEA, NJ Fish & Wildlife, FDA, Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC), and Office of Laboratory Animal Welfare (OLAW).

o Hosted numerous site visits and inspections by governing bodies. Authored annual reports for 3 research sites, maintained federal and state licenses, and full accreditation.

• Oversaw staff training; developed online training modules, SOPs, and compliance guidelines.

• Successfully interacted with domestic and international contract research organizations (CROs) to review US standards and laws in connection to protocols design and animal welfare compliance.

• Led the collective bargaining unit, exempt, and hourly staff. Selected for a corporate award for successfully negotiating collective bargaining unit contract in 2011, resulting in a 22% savings.

Sally K. Wixson, V.M.D., M.S., D.A.C.L.A.M. – Page 2

908-***-**** | w6ex8h@r.postjobfree.com

SCHERING-PLOUGH RESEARCH INSTITUTE, Kenilworth, NJ 2006-2009

Senior Director, Laboratory Animal Resources (2008-2009); Director, Veterinary Services (2006-2008)

Applied pharmaceutical department leadership and administrative skills to provide state-of-the-art research collaboration and veterinary preventive, medical and surgical care. Maintained an excellent record of regulatory compliance.

• Aligned priorities to customers’ needs, including leveraging voice of the customer (VOC) and Six Sigma practices to deliver program excellence.

• Designed and completed study protocols requiring complex animal models. Developed large and small animal surgical models. Managed and motivated internal study support teams.

• Trained professional, exempt, hourly and union staff, and led departmental development initiatives, resulting in improved performance, morale, productivity, and decreased absenteeism.

JOHNSON & JOHNSON PHARMACEUTICAL RESEARCH & DEVELOPMENT, Raritan, NJ 1999-2006

Senior Site Manager, Global Preclinical Development, Laboratory Animal Medicine (2001-2006)

Provided direct and ongoing leadership as part of managing and maintaining 3 separate research facilities.

Served as a key member of a team that developed site Service Level Agreement (SLA) with customers.

Manager, Laboratory Animal Services, Skin Research Center (1999-2001)

Previous Experience:

BASF BIORESEARCH CORPORATION, Worcester, MA (1995-1999)

Director of Animal Resources, Knoll Pharmaceuticals (1997-1999)

Department Head, Animal Research Facility (1995-1997)

GEISINGER CLINIC, WEIS CENTER FOR RESEARCH, Danville, PA (1988-1995)

Director of Comparative Medicine & Surgery / Staff Scientist (1991-1995)

Attending Veterinarian / Associate Scientist (1988-1991)

• Obtained funding for 4 N.I.H. funded research grants as Primary Investigator and one N.I.H. funded Facility Improvement Grant.

SMITH KLINE & FRENCH LABORATORIES, Philadelphia, PA (1985-1987)

Senior Staff Veterinarian, Research and Development Division

EDUCATIONAL ACHIEVEMENT

RUTGERS UNIVERSITY, New Brunswick, NJ

Mini MBA in Biopharmaceutical Innovation

MERCER COUNTY COMMUNITY COLLEGE, West Windsor, NJ

Certificate - Project Management Professional Exam Preparation

THE AMERICAN COLLEGE OF LABORATORY ANIMAL MEDICINE

Diplomate

THE PENNSYLVANIA STATE UNIVERSITY, Milton Hershey Medical Center, Hershey, PA

MS in Laboratory Animal Medicine (Honors)

THE UNIVERSITY OF PENNSYLVANIA SCHOOL OF VETERINARY MEDICINE, Philadelphia, PA

VMD (Cum Laude)

THE PENNSYLVANIA STATE UNIVERSITY, University Park, PA

BS in Animal Science – Pre-Vet (High Distinction)

THE REGULATORY PROFESSIONALS SOCIETY, Bethesda, MD

Regulatory Affairs Dual Certificate – Drugs and Medical Devices

Regulatory Affairs Certified Professional



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