Senior Strategic Program Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Lead cross-functional initiatives that introduce new clinical products to the market while improving existing offerings, with an emphasis on Design Control and New Product Introduction.

• Collaborate with R&D, business, operations, and engineering teams to establish objectives, milestones, and strategic plans.

• Oversee product development from initial concept to commercialization and through the post-launch phase.

• Create and uphold project plans, protocols, reports, and various program documentation.

• Monitor progress and relay outcomes through data-driven reports and updates to senior leadership.

• Administer Design Control gate reviews, design freezes, technical evaluations, change control, and regulatory submissions.

• Organize team meetings, facilitate decision-making, and identify and mitigate potential risks.

• Navigate trade-offs and risk decisions encompassing technical, business, and regulatory aspects.

• Promote teamwork and problem-solving to address challenges and resolve conflicts.

• Coordinate collaborative development efforts with external partners.

• Manage up to four programs concurrently.

⛳️ Requirements

• A Bachelor's degree in Biology, Molecular Biology, Biochemistry, Bioinformatics, Computer Science, or a related technical field (or equivalent experience) is required.

• Project management certification or training (e.g., PMP or equivalent) is necessary.

• A minimum of 4 years of program management experience in biotech, life sciences, or another regulated technical industry is required.

• A background in research, assay development, systems engineering, lab operations, or software development is highly desirable.

• Familiarity with laboratory informatics systems and LIMS, sample accessioning, sequencing pipelines, and results reporting is preferred.

• At least 5 years of project budget management experience is preferred.

• Knowledge of software development lifecycle principles, data architecture patterns such as SOA, and agile tools like Jira and GitLab is a plus.

• Experience in creating and maintaining complex Gantt charts, project plans, and risk/RAID logs is required.

• Expert-level proficiency in project management and scheduling tools such as SmartSheet or equivalent is essential.

• Understanding of product development under FDA Design Controls and relevant regulations is desirable, including 21 CFR, ISO 13485, ISO 15189, EU IVDR, and Section 524B for Cybersecurity.

• Exceptional communication and interpersonal skills are crucial.

• Strong organizational skills, resilience, adaptability, time management, and multitasking capabilities are necessary.

• Ability to work independently and effectively contribute to cross-functional teams is required.

🏝️ Benefits

• Comprehensive medical, dental, vision, life, and disability plans for eligible employees and their dependents.

• Complimentary testing for employees and their immediate families.

• Fertility care benefits.

• Leave for pregnancy and baby bonding.

• 401(k) benefits.

• Commuter benefits.

• Employee referral program.