Adela is seeking a highly motivated and creative individual to join the Product & Program Management team. This is an exciting opportunity to be part of a growing, dynamic, and collaborative company delivering cutting-edge technology directly to clinicians. The primary function of this position will be to execute technical program strategies through collaborating with internal cross-functional teams that require a high-level of detail, organization, and planning. 

The ideal candidate will be able to lead product development and interface with highly detailed and specialized internal functions including platform development, laboratory operations, medical device regulatory and compliance software development, bioinformatics, and data science among others. This individual will be a self-starter who is looking to manage the lifecycle of complex projects in software and biometrics that support the development of a medical device. This role will report to the Senior Director of Product & Program Management.

 Responsibilities

      Manage multiple cross-functional groups in a matrixed environment and partner with them to deliver on execution of business and product strategy, specializing in the management of medical device software, regulatory, and assay teams.

      Creation, tracking, and escalation of multiple timelines using different project management methodologies.

      Understanding the need to go beyond managing project teams at a high-level and dive into the granular details of each project and represent multiple subject matter experts as needed.

      Collaborate and develop goals, milestones, processes, project plans, detailed timelines, and associated project documents with cross-functional project teams.

      Have a working knowledge of SDLC and its technical requirements as it relates to the regulatory process for launching a medical device.

      Lead and facilitate regular team meetings, and record and send out meeting notes and actions.

      Analyze ongoing risk assessments for project teams and flag potential risks to develop clear mitigation plans and corrective measures as necessary.

      Provide regular updates to the broader Product & Program Management team from project team meetings, highlighting key dependencies and risks to timelines.

      Represent the Product & Program Management group as a key stakeholder in cross-functional workstreams and initiatives.

      Identify and implement best practices and process improvements, and ensure adherence to ICH, GCP and local regulations among cross-functional teams.


 Education & Experience

      BS, MS preferred in scientific field or equivalent.

      Minimum of 5-7 years of experience in technical project/program management, product development, and/or software development/informatics in a pharmaceutical, biotechnology, health-tech, or diagnostics organization.

      Familiarity with project management and software development tools such as Jira, Smartsheet, and GitHub as well as other configuration management tools.

      Project Management Professional (PMP) certification preferred.

      Well-developed organizational and interpersonal skills with attention to detail.

      Skilled at innovation, collaboration, and execution of business strategy.

      Ability to identify and resolve complex issues.

      Excellent written and verbal communication skills.