Product Manager – IVD Assays (ADX-104-20)
THE COMPANY: ArcherDX, Inc. - www.ArcherDX.com
ArcherDX is a leading genomic analysis company democratizing precision oncology through a suite of products and services that are highly accurate, personal, actionable and easy to use in local settings. Our Archer® platform, with our proprietary Anchored Multiplex PCR (AMP™) chemistry at the core, has enabled us to develop industry-leading products and services to optimize therapy and enable cancer monitoring across sample types. We develop and commercialize research use only (RUO) products, are developing in vitro diagnostic (IVD) products, and offer services that meet the unique needs of our customers and their clinical applications. Our research product portfolio consists of VariantPlex®, FusionPlex®, LiquidPlex™ and Immunoverse™. IVD products currently in development for solid tumor biomarker identification and Personalized Cancer Monitoring (PCM) have both received Breakthrough Device Designation from the FDA. ArcherDX is headquartered in Boulder, Colorado. Learn more at www.archerdx.com and follow @ArcherDXInc on Twitter, Facebook and LinkedIn.
Are you passionate about precision oncology and improving patient access to personalized molecular detection tools that can be used in local settings? As an IVD Product Manager you will be responsible for bringing new IVD products through the R&D and regulatory review processes and supporting their launch and commercialization. You will orchestrate and 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 managing successful IVD launches providing marketing input, identifying key portfolio/feature gaps, and prioritizing feature requirements in support of clinical molecular testing for solid tumors and heme malignancies. As the product owner, you will interact with other departments including R&D, Project Management, Regulatory Affairs, Quality, Market Access, Manufacturing, Software, Global and Regional Marketing, Customer Support and Finance to ensure that products successfully enter into the market and that budgets, timelines and performance objectives are met.
Job performance will involve a variety of activities including:
- Champion the Voice of Customer (VOC) and assist with the development of user needs pertaining to the development of the IVD.
- Develop one, three, and five-year product roadmaps.
- Lead the cross-functional product core team through the design and development plans of current and future IVDs.
- Work closely with sub-teams to successfully develop and launch complex IVD products comprised of assays and software while meeting timeline and budget targets.
- Drive new product introductions to completion by leading teams through the validation and regulatory submission phases of product development.
- Leverage technical expertise in molecular diagnostics and regulatory strategy insights to bring new technologies and product concepts through uncharted regulatory paths.
- 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 BD, CMO, MSLs, Project Managers, Commercial, Regulatory, Software, Finance and other key functions and teams.
- Partner with Global Marketing and Business Development to incorporate regional considerations in portfolio decisions and go to market priorities.
- Ensure successful implementation of our go to market plans to accomplish customer adoption, use goals and financial objectives.
- Own the customer-driven process to define user workflow in different use settings and communicate this workflow to sub-teams for implementation.
- Drive successful relationships with key customers to ensure we understand emerging trends and successful adoption of new products.
- Provide technical marketing support to sales/support teams, training and tool development.
- Actively monitors industry to understand the competitive environment and anticipates precision oncology market trends and demands. Use knowledge to evaluate, update and manage change (as appropriate) for in flight products.
- Lead cross-functional groups and drive accountability even if not in the same department.
- 5-10% travel both domestically and/or internationally, as required.
- 3+ years of experience in product management or customer-facing function in medical device or diagnostics industries.
- 7+ years combined IVD industry experience in marketing/product management and clinical lab experience.
- 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.
- Previous experience working with pharma companies a plus.
- Experience in marketing and driving development of global products in a plus.
- 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 with advanced knowledge of IVD product development and regulatory requirements.
- 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 in a highly complex matrix environment, with a proven ability to influence without formal authority and achieve results through people.
- 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.
EDUCATION & KNOWLEDGE:
- Advanced degree(s) in life sciences (ie MS/PhD/PharmD) required; MBA preferred but not required.
- Strong technical knowledge of next-generation sequencing workflows (sample to data) required.
- Understanding of clinical laboratory operations and CAP/CLIA requirements.
- Deep understanding of the product development process, project management, IVD regulations, IVD market a plus.
Read Full Job Description