Cleveland Diagnostics (CDx) is a fast-growing, venture-backed, commercial-stage biotechnology company developing next-generation diagnostic platforms and products, such as our proprietary IsoClear platform and our first product, IsoPSA for prostate cancer. We operate in a high-intensity, agile environment where clinical impact meets cutting-edge technology. Our mission is to bring actionable clarity to the diagnosis and treatment of complex diseases, such as cancer, and we envision a future where disease derived insight guides every major care decision.
Job Title
Director, Product Management – Diagnostics
Reports To
The Director, Product Management – Diagnostics will report to the Chief Commercial Office
Job Overview
The Director, Product Management will define and execute the global
product strategy for our diagnostic portfolio, leading end-to-end product strategy (i.e., from early-stage conceptualization through clinical validation, regulatory approval, and commercial launch) and across commercial segments. Importantly, this individual will drive the marketing of our new IVD kit as a product and evaluate and execute its delivery through new and existing lab channels.
This role will bridge the gap between R&D, the clinical lab, regulatory, compliance, and commercial operations. This position will work closely with and support the existing Sales and Marketing teams -- particularly in collaboration with the SVP of Sales and the VP of Marketing -- and be a valuable member of the company’s senior leadership team (SLT).
Key Responsibilities & Duties
Strategy & Lifecycle Management
- Define the long-term product roadmap based on market needs for both new and existing products across all potential IsoClear product applications.
- Translate complex scientific capabilities into clear product requirements.
- Own the product lifecycle from concept to commercialization.
- As part of this role, this individual will identify and socialize needed product performance improvements and areas for additional clinical study, as well as propose areas for market expansion.
- This individual will coordinate with Marketing to analyze market segments and craft effective product launch strategies.
- Assist the VP of Marketing in the establishment of pricing strategies and product positioning in the market and the Market Access team in its pursuit of reimbursement.
- Assist Sales, Marketing, and Commercial Operations with technical product training.
Cross-Functional Leadership
- Partner with R&D to evaluate technology feasibility and map to market needs and requirements.
- Collaborate with Clinical, Regulatory, Medical Affairs, Legal, and Compliance teams regarding necessary clinical trials, and supportive cost effectiveness and clinical utility studies.
- Support Regulatory affairs on FDA and CE-IVD submissions.
Market Intelligence & Business Development
- Support the VP of Marketing in the conduct of deep market research re customer needs and reimbursement landscapes.
- Continually analyze competitor landscape and emerging diagnostic technologies.
- Alongside of the Marketing and Sales teams, engage with KOLs and other practicing clinicians, and identify strategic partnership opportunities with healthcare providers.
Required Qualifications
- Experience: 10+ years in product management within healthcare, with a strong preference for diagnostics experience in the oncology field.
- Education: Bachelor’s degree or advanced degree in Bioengineering, Biology, or a related field.
- Domain Expertise: Prior success launching and managing lifecycles for LDT and IVD products.
- Startup Agility: Proven ability to thrive in ambiguous environments.
Preferred Qualifications
- Advanced degree such as MBA
- International marketing experience a plus, as well as experience marketing to institutions.
Physical Requirements/ Working Conditions/Equipment Used:
- Ability to: sit, stand and/or walk throughout course of day; operate a computer and multitask across many software communication and data entry programs while operating and communicating through telephone device for several hours a day.
Other Requirements
- This is a remote position