PatientsLikeMe is at an exciting stage in our growth and development and we are seeking a driven, process oriented leader to work with our Senior Leadership to take us to the next stage in our life cycle and beyond. This is an excellent opportunity for a motivated individual, to influence change and development in an organization poised for significant growth. Reporting to the COO, the major purpose of the role and duties include:
Purpose of the Job
- Build a collaborative, flexible program management infrastructure that combines traditional program management responsibilities with an evolving design control process.
- Facilitate annual corporate execution planning amongst senior leadership team.
- Accelerate cycles of learning from programs and rapidly integrate lessons learned.
- Program Manage concurrent strategic development/implementation projects in Global Regulated environments; managing scope, schedule, issues/risks, trade-offs, communications and expectations.
- Deliver execution excellence in product development:
- Drive collaborative discussions and decisions with all key stakeholders
- Focus at a detailed level on multiple strategic projects simultaneously
- Making optimal use of the Product Development Phase Gate process
Major Duties and Responsibilities
- Establish and report corporate scorecard (R&D, S&M, G&A, COGS)
- Build a lean program management function that meets business needs
- Establish and maintain strategic development/implementation projects in regulated and unregulated commercial environments; managing scope, schedule, issues/risks, trade-offs, communications and expectations
- Work with business partners to define and prioritize program requirements and scope.
- Lead, manage and be accountable for the flawless execution of key programs. Manage project plan and schedule. Assist team in budget management, ensure plan is integrated and aligned to overall organizational and business strategy.
- Develop accurate and actionable project plans with milestones and contingency plans as needed based on budget, timing, and business need.
- Partner with key business pillars (including Marketing, Product Development, Regulatory and operations) to develop develop and manage business contingency plans and manage business opportunities and identified risks.
- Collaborate and coordinate across all the Functional areas within and related to Programs: Regulatory, Bioresearch, Engineering, Product Management, QA/QC, Clinical, Medical Affairs, Marketing, Legal, Operations, Service and Support and others.
- Establish and Manage strong partnerships with internal teams across the company.
- Communicate Program status to key stakeholders and to exec management including board members as needed and required
Education and/or Job Experience:
- Bachelor’s degree (B.S./B.A.) minimum, preferably in a scientific/technical discipline (e.g. biology, chemistry, engineering)
- Minimum of 10 years of industry experience in product/program management and product development and demonstrated success in developing, launching and supporting software applications, life science / diagnostic products and Laboratory Developed Tests (LDT’S).
- Previous experience in research consumer products further developed into diagnostic and medical device preferred.
- Stage-gate product development process experience from global companies preferred.
- Strong project management and cross-group skills, including the ability to get what you need from others while working around their own legitimate priorities.
- Demonstrated ability to work in a complex, rapidly changing, high growth organization.
- Strong prioritization and organizational skills.
- Demonstrated strong problem solving skills.
- Moderate travel
Special Skills, Abilities, and Requirements:
- Adaptability, flexibility and the ability to do the right thing under pressure and tight deadlines in a complex, matrixed environment.
- Demonstrated ability in developing a program management function within a multi-disciplinary technical environment.
- Operational leadership and an understanding of partner and customer requirements.
- Strong leadership skills particularly the ability to influence stakeholders.
- Advanced written, oral, and interpersonal communication skills.
- Able to work closely with highly technical teams and quickly understand mutli-disciplinary concepts
- High attention to detail and accuracy required.
- Working knowledge of FDA Quality System Regulations,( 21 CFR Part 820) ISO 13485 (Quality Management for Medical Devices and Clinical Laboratory Improvement Amendments (CLIA) of 1988.
- PMP certification a plus
- Mandarin language skills desirable
- This position is based out of our office in Cambridge, MA