MEDICAL AFFAIRS PROGRAM MANAGER, VIRAL LOADS
Sparks, NV 89434
Location: Sparks, Nevada
Company: Top Medical Device Company
Compensation: $120K to $155K Base + Bonus + Amazing Benefits
Contact: Ken Kupersmith- [email protected]
Seeking an experienced Medical Affairs Program Manager (MAPM-VL) for the achievement of business objectives in the molecular viral loads (HIV/HBV/HCV). Responsibilities include representing Medical Affairs (MA) on Core Teams/Product Development Teams to participate in critical product development decisions.
The MAPM-VL demonstrates expert understanding of advanced technical/scientific principles applicable to disciplines such as R&D, Quality, Business, or Project Management, and is recognized as an MA technical subject matter expert.
The MAPM-VL role will:
1.Maintain relationships with key opinion leaders in the field of molecular blood viral diagnostics
2.Develop publication strategies for clinical evidence studies
3.Accountable for Medical Affairs decisions, tactics and execution within platform/program areas of focus
4.Represent BD to external stakeholder groups and organizations
5.Contribute to regulatory strategies and interactions with US and ex-US regulatory authorities and/or Standards Committees
6.Build operational functional excellence in product development and clinical research.
7.Possess subject matter expertise in all aspects of clinical trial management, especially project management, good clinical practices (GCP) and human subject protections
8.In-depth knowledge of commercial viral load diagnostic products, product development process, ISO standards and design control
9.Supports MA responsibilities associated with Health Hazard Evaluations by providing relevant medical/clinical input
10.Responsible for indirect leadership of associates, including coaching and feedback including providing MA oversight and expertise to study teams, extended functional teams or work groups
11.Inspire effective business/function dynamics, and imparts a sense of commitment to business/function goals
12.Applies extensive technical expertise in the molecular viral loads diagnostic area (HIV, HBV and HCV) or product/platform, with in-depth knowledge of design control and product development, statistics and data management. Can Interpret and describe complex data.
13.Develops and implements clinical plans for projects consisting of multiple studies in support of product design validation and claims.
14.Creates complex, coherent, professional documentation and correspondence. Prepares formal written reports/documents for distribution within department.
15.Develops components of a functional budget.
16.Independently develops and presents training material
Education and Experience Qualifications:
1.Requires/Preferred a Doctorate Degree; Ph.D. in biological or pharmaceutical sciences, PharmD, MD, NP, PA or MPH.
2.Minimum of 5 years of industry or clinical experience in Medical Affairs, Clinical Development, or Research including:
oClinical trials management and scientific expertise
oManaging multiple complex or multi-stage projects
oHepatology, HIV, infectious diseases or clinical virology diagnostics
oClinical patient care highly desirable