Headquartered in Tucson, Arizona, we are a provider of instruments and reagents for molecular profiling applications. Our mission is to empower precision medicine at the local level. Our next-generation sequencing (NGS)-adapted chemistry and instrument platforms automate sample processing and can quickly, robustly, and simultaneously profile hundreds or thousands of molecular targets from samples a fraction of the size required by competitive technologies, enabling customers to do more molecular profiling with less sample.
Additional information about us is available at www.htgmolecular.com.
THIS IS A FIELD BASED POSITION. EMPLOYEE DOES NOT NEED TO RESIDE IN TUCSON.
This position requires a passion for precision medicine and improving patient access to new personalized gene expression technologies. As a Senior Product Manager/ Director for diagnostic assays - you will be responsible for leading the development, launch and commercialization of new in vitro diagnostic (IVD) products through the R&D and regulatory review processes. You will lead a collaborative planning process to define and execute the IVD assay strategy to support the Company’s commercial business goals. This role will have responsibility for providing marketing input, identifying key portfolio/feature gaps, and prioritizing feature requirements in support of clinical molecular testing. As the product owner, you will interact with other departments including R&D, Project Management, Regulatory Affairs, Quality, Manufacturing, Software, Global Marketing, Customer Support and Finance to ensure that products successfully enter into the market and that budgets, timelines and performance objectives are met.
- Champion the Voice of Customer (VOC) and lead the development of user needs pertaining to the development of in vitro diagnostic (IVD) products.
- Provide technical leadership in the development and coordinate with cross-functional project team to define key development deliverables, milestones, and dependencies of current and future IVD products.
- Participate in developmental 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 market opportunities and proposals. This includes creation of strategic plans, product definitions, market segmentation, collection of voice of customer, product requirements, market analysis and input into the annual Marketing Budget.
- Build strong relationships and collaborations with R&D, Pharma Business Development, Project Management, Commercial, Regulatory, Software, Finance and other key functions and teams.
- Drive successful relationships with key customers to ensure we understand emerging trends and successful adoption of new products.
- Ability to travel up to 25% of the time, both domestically and/or internationally, as required.
EDUCATION & EXPERIENCE:
- 10+ years of experience in product management or customer-facing function in life science, medical device or diagnostics industries.
- Degree in life sciences (BS/MS/PhD) required; MBA preferred but not required.
- Strong technical knowledge of next-generation sequencing workflows (sample to data) required.
- Understanding of Contract Research Organizations (CROs) and clinical laboratory operations; knowledge of CAP/CLIA requirements a plus.
- Experience in the following research areas: immunology, oncology, autoimmune
- Strong leadership capabilities and the ability to lead multiple projects through a complex development program are required.
- Proven experience working in cross-functional product development teams.
- Experience in marketing and driving development of global products
- Experience working on globally regulated products and/or the development of regulated products is preferred.
- Experience working within the molecular IVD market and strong knowledge of current CDx products and competition is preferred.
- Demonstrated experience working with financial models and building NPV-based cost justifications.
- Experience working directly with key opinion leaders and conducting voice-of-customer research.
- Experience working under design control.
- Drive and determination.
- Strict attention to detail.
- Possesses high integrity and exceptional work ethic.
- Fosters mutual trust, respect and is an excellent team player.
- Meets challenges consistently and confidently with energy and drive.
- Motivated by results, urgency and personal commitment.
- Able to work effectively as “self-starter”, with proven ability to influence without formal authority and achieve results.
- Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives.
- Ability to interact with senior management, and others concerning matters of significance to the Company.
- Proven problem-solving skills, and comfort in working in a dynamic environment with rapidly evolving business needs.
- Excellent organizational, analytical and critical thinking skills including high discretion/judgment in decision making.
- Strategic thinker that understands drug development, device development, design control and commercial strategy.
Nestled at the foothills of the majestic Catalina Mountains, and ringed by 4 other mountain ranges, a young and family friendly modern metropolis, Tucson offers 276 days of sunshine, unparalleled golf, museums, historic sites and hiking trails where one can experience the wide variety of animal and plant life of the Sonoran Desert, one of the most biodiverse spots on the planet.
HTG offers competitive salaries and an attractive benefits package including 100% employer paid medical and dental benefits, long term disability and life insurance, an employee stock purchase plan, and the unique ability to work with cutting edge technological advances.
Please apply here.
HTG is an Equal Opportunity Employer