What are the responsibilities and job description for the Director of Product Development (Head of R&D) position at Watershed Therapeutics?
Director, Product Development (Head of R&D)
Location: Seattle, WA (On-Site) Job Type: Full-time Level: Relocation: Not available. Local candidates only.
About the Role: Watershed Therapeutics is building a platform for long-residence, intravesical drug delivery that changes how urologists treat chronic bladder disease. The company’s core product is a shape-changing, buoyant polymer implant that is inserted via a standard catheter, remains in the bladder, and releases drug continuously for weeks to months. We are seeking a Director of Product Development to serve as the Head of R&D. You will own the scientific roadmap, driving the integration of formulation, device, and analytical development to advance the development of products through the clinic.
This is a "Player-Coach" role. While you will drive strategy and manage external partners, we are a lean startup. You must be willing to provide hands-on technical leadership, troubleshooting complex formulation challenges in the lab alongside your team when necessary.
Key Responsibilities
R&D Leadership: Build and lead the internal R&D organization, including the recruitment and mentorship of senior scientists and technical staff.
Product Architecture: Serve as the lead architect for our solid dosage forms and complex delivery systems, ensuring scalability from bench to clinic.
Functional Oversight (Analytical & Device): Provide direct technical oversight for Analytical Development and Device Engineering. You will ensure these functions are synchronized with formulation efforts to support a seamless drug-device combination strategy.
CDMO Strategy & Management: Own the external manufacturing strategy. You will identify, contract, and manage CDMOs, negotiating Master Service Agreements (MSAs) and Quality Agreements to ensure GMP readiness.
Hands-On Execution: Maintain a strong physical presence in the lab. You will review raw data, troubleshoot experimental anomalies, and personally oversee critical prototype fabrication.
Regulatory & Quality: Partner with regulatory service providers to define the CMC strategy for 505(b)(2) submissions and ensure all development work meets Design Control and GMP standards.
Budget & Milestones: Manage the R&D budget and ensure technical execution aligns with investor milestones and clinical timelines.
Qualifications
Education: PhD in Pharmaceutical Sciences is required.
Experience: 10 years of industry experience in pharmaceutical product development.
Technical Expertise:
Deep expertise in Solid Dosage Forms (granulation, tableting, extrusion) is mandatory.
Proven track record of developing drug-device combination products through late phase development.
Strong working knowledge of analytical method validation and device design controls.
External Management: Demonstrated success in selecting and managing CDMOs for early-phase clinical manufacturing (Phase 1/2).
Leadership Style: A "doer" who leads from the front. You must be comfortable working in a fast-paced, resource-constrained startup environment without a large administrative support structure.
Location: Must be currently based in the Greater Seattle area.