Program Manager, IVD Assay Development

Epic Sciences, Inc. is developing novel diagnostics to personalize and advance the treatment and management of cancer. Epic’s mission is to enable the rapid and non-­‐invasive detection of genetic and molecular changes in cancer throughout a patient’s journey. The company was founded on a powerful platform to identify and characterize rare cells, including circulating tumor cells (CTCs). Our technology helps match patients to targeted therapies and monitor for drug resistance, so that the best treatment path can be chosen at every clinical decision point. Today, we partner with leading pharmaceutical companies and major cancer centers around the world. Epic’s goal is to commercialize our technology to increase the success rate of cancer drugs in clinical trials and improve patient outcomes by providing physicians real-­‐
time information to guide treatment choices. Program Manager, IVD Assay Development SUMMARY: The Program Manager directs all phases of a BioPharma program, leading the full program lifecycle of client engagement from initial Statement of Work (SOW) development to contract closure or transfer. The Program Manager position manages program costs, quality objectives, and schedules to ensure quoted standards and internal/external customer goals are met. The Program Manager is responsible for several concurrent programs, including cross-­‐organizational team members ESSENTIAL FUNCTIONS: • Applies advanced experience, leadership skills and performance to the oversight of multiple, related projects or complex programs, to achieve strategic business goals using full project management lifecycle for key programs, projects, and services • Maintains continuous alignment of program or project scope with strategic business goals and possesses advanced skills in finance, leadership, communication, influence, negotiation, cross-­‐cultural awareness, and conflict resolution. • Works cross-­‐functionally and consults frequently with all Lab departments, Information Technology, Application Development, Testing, Quality, Regulatory and Product Development, in addition to other functional groups based on program or project scope • Supports the strategic direction of the programs associated with corporate goals • Communicates program or project goals, status, requirements and deliverables to all team members, stakeholders, and sponsors • Leads cross-­‐functional teams, to develop and deliver solutions or capabilities which meet the defined delivery timeline, design inputs, and quality metrics to support the company goals • Establishes milestones and monitors adherence to master plan and schedule • Tracks and reports status of programs and projects within prescribed development paths. • Measures and reports cost and schedule performance against objectives Is responsible for the budget, schedule, resource management, and performance of assigned programs or projects • Applies project management processes to achieve the highest team performance and value added effort • Works effectively with all team members, stakeholders and sponsors • Coaches and develops team members as necessary to assure common understanding of the Project Management and Software Development process and project goals • Effectively communicates and maintains visual tools for program or project tracking and management • Effectively learns and employs Epic processes, tools and concepts to maximize efficiency and quality EPIC SCIENCES, INC • 9381 Judicial Drive, Suite 200 • San Diego, CA 92121
ADDITIONAL DUTIES: May perform additional duties as assigned or directed by management from time to time EDUCATION/EXPERIENCE REQUIRED: • Bachelor’s degree in Life Science, Engineering, Medical device business management or related field or equivalent work experience is required • Minimum of 5-­‐7 years of relevant work experience in scientific or engineering product development and/or project management; experience in a regulated IVD environment is required Preferred: •
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Project management Professional (PMP) certification or similar certification or formal training is recommended Experience in a CLIA or CAP accredited clinical lab environment is preferred Experience with AGILE or other iterative Software Development Lifecycle models and full lifecycle project management are required Understanding of ISO and FDA regulations with regards to design, process, and document control, process validation, and GLP Demonstrated experience in working with software development and IT is required Strong written and oral communication skills are required; ability to interact productively with teams outside of the U.S. and across multiple time zones. Language and cultural awareness learning may be required based on customer needs REQUIRED SKILLS: • Demonstrated leadership in product development projects and full lifecycle project management is required • Expert user of Microsoft Project is required • Strong motivational leadership skills and the ability to influence others without direct authority is required • Strong written and oral communication skills is required • Highly self-­‐motivated • Strong time management and planning skills • Exceptional interpersonal and communication skills, works well with others • Close attention to details, ability to troubleshoot and maintain accurate records REQUIRED COMPETENCIES: • Performance Orientation – Is driven by personal performance; achieves all objectives detailed in scorecards and comfortable with quantifiable assessments. • Impact Orientation – Performs to stated objectives and driven to make an impact on company goals and patients’ lives. • Competitive – Dedicated to a competitive spirit that supports the Epic Sciences’ goal to be the premier CTC technology in the industry. • Sense of Urgency – Has the speed and agility dedicated to the company’s goals and performance. • Ability to Handle Pressure and Ambiguity – Comfortable with the pressure to be the best and the ability maintain composure and focus in situations of ambiguity and uncertainty. • Confidence -­‐ Confident in one’s skills and abilities; pursues everything with energy; demonstrates the drive and a need to finish especially in the face of resistance or setbacks. EPIC SCIENCES, INC • 9381 Judicial Drive, Suite 200 • San Diego, CA 92121
PHYSICAL DEMANDS: • The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. • While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to sit. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel and reach with hands and arms. • The employee must occasionally lift and/or move up to 10 pounds. • Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. • Standing for long periods of time. • Transition from standing and sitting often. WORK ENVIRONMENT • The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. • General office environment. Daily exposure to PCs and networks. • May occasionally move heavy equipment and/or boxes. • The noise level in the work environment is usually moderate. Disclaimer:
The above statements are intended to describe the general nature and level of work performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.
Epic Sciences is an Equal Opportunity Employer and committed to the principle of diversity EPIC SCIENCES, INC • 9381 Judicial Drive, Suite 200 • San Diego, CA 92121