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Sr. Product Manager/Director - Diagnostic Assays

Company: HTG Molecular Diagnostics, Inc
Location: Tucson
Posted on: September 13, 2020

Job Description:

Headquartered in Tucson, Arizona, we are aprovider of instruments and reagents for molecular profilingapplications. Our mission is to empower precision medicine at thelocal level. Our next-generation sequencing (NGS)-adapted chemistryand instrument platforms automate sample processing and can quickly, robustly,and simultaneously profile hundreds or thousands of molecular targets fromsamples a fraction of the size required by competitive technologies, enablingcustomers to do more molecular profiling with less sample.



This position requires a passion for precision medicineand improving patient access to new personalized gene expression technologies.As a Senior Product Manager/ Director for diagnostic assays - you will beresponsible for leading the development, launch and commercialization of new invitro diagnostic (IVD) products through the R&D and regulatory reviewprocesses. You will lead a collaborative planning process to define and executethe IVD assay strategy to support the Company’s commercial business goals. Thisrole will have responsibility for providing marketing input, identifying keyportfolio/feature gaps, and prioritizing feature requirements in support ofclinical molecular testing. As the product owner, you will interact withother departments including R&D, Project Management, Regulatory Affairs,Quality, Manufacturing, Software, Global Marketing, Customer Support andFinance to ensure that products successfully enter into the market and thatbudgets, timelines and performance objectives are met.


Champion the Voice of Customer (VOC) and lead the development ofuser needs pertaining to the development of in vitrodiagnostic (IVD) products.

Provide technicalleadership in the development and coordinate with cross-functional project teamto define key development deliverables, milestones, and dependencies of currentand future IVD products.

Participate indevelopmental and regulatory strategies to commercialize novel IVD products,companion diagnostics, drug/device combination products.

Develop one, three, and five-year product roadmaps.

Ability to create and validate business cases for new marketopportunities and proposals. This includes creation of strategic plans, productdefinitions, market segmentation, collection of voice of customer, productrequirements, market analysis and input into the annual Marketing Budget.

Build strong relationships and collaborations with R&D, PharmaBusiness Development, Project Management, Commercial, Regulatory, Software,Finance and other key functions and teams.

Drive successful relationships with key customers to ensure weunderstand emerging trends and successful adoption of new products.

Ability to travel up to25% of the time, both domestically and/or internationally, as required.


10+ years of experiencein product management or customer-facing function in life science, medicaldevice or diagnostics industries.

Degree in life sciences(BS/MS/PhD) required; MBA preferred but not required.

Strong technicalknowledge of next-generation sequencing workflows (sample to data) required.

Understanding of ContractResearch Organizations (CROs) and clinical laboratory operations; knowledge of CAP/CLIArequirements a plus.

Experiencein the following research areas: immunology, oncology, autoimmune

Strong leadershipcapabilities and the ability to lead multiple projects through a complexdevelopment program are required.

Experience in marketingand driving development of global products

Experience working onglobally regulated products and/or the development of regulated products ispreferred.

Experience workingwithin the molecular IVD market and strong knowledge of current CDx productsand competition is preferred.

Demonstrated experienceworking with financial models and building NPV-based cost justifications.

Experience workingdirectly with key opinion leaders and conducting voice-of-customer research.

Experience working underdesign control.


Drive and determination.

Strict attention todetail.

Possesses high integrityand exceptional work ethic.

Fosters mutual trust, respectand is an excellent team player.

Meets challengesconsistently and confidently with energy and drive.

Motivated by results,urgency and personal commitment.

Able to work effectivelyas “self-starter”, with proven ability to influence without formal authorityand achieve results.

Excellent written andverbal communication skills and interpersonal relationship skills includingnegotiating and relationship management skills with ability to driveachievement of objectives.

Ability to interact withsenior management, and others concerning matters of significance to theCompany.

Proven problem-solvingskills, and comfort in working in a dynamic environment with rapidly evolvingbusiness needs.

Excellentorganizational, analytical and critical thinking skills including highdiscretion/judgment in decision making.

Strategic thinker thatunderstands drug development, device development, design control and commercialstrategy.

Nestled at the foothills of the majestic Catalina Mountains, andringed by 4 other mountain ranges, a young and family friendly modernmetropolis, Tucson offers 276 days of sunshine, unparalleledgolf, museums, historic sites and hiking trails where one can experiencethe wide variety of animal and plant life of the Sonoran Desert, one of themost biodiverse spots on the planet.

HTG offers competitive salaries and anattractive benefits package including 100% employer paid medical and dentalbenefits, long term disability and life insurance, an employee stock purchaseplan, and the unique ability to work with cutting edge technological advances.

HTGis an Equal Opportunity Employer

HTG Molecular Diagnostics, Inc. is an EEO employer - M/F/Vets/Disabled

Upload Your Resume Accepted formats: .pdf, .doc, .docx

Keywords: HTG Molecular Diagnostics, Inc, Tucson , Sr. Product Manager/Director - Diagnostic Assays, Other , Tucson, Arizona

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