Achaogen is seeking an experienced and highly motivated Director, Device Project Team Leader (PTL) to be accountable for project leadership and management of diagnostic device programs from early development through commercial. The position will lead cross-functional teams tasked with diagnostic development, launch, and commercialization in support of Achaogen’s drug portfolio. The position has cross functional leadership scope that includes partner management, R&D, quality, regulatory, clinical, and commercial. The PTL will be accountable for exceptional strategy development and execution for diagnostic device related activities, and will identify and advocate for the people and processes needed for device development and commercialization.
Achaogen is growing rapidly to support an expanding pipeline of potential drug therapeutics, for which successful diagnostic development and commercialization is critical (in vitro diagnostics, antimicrobial susceptibility testing, rapid identification tests). The successful candidate will be able to contribute as a leader cross-functionally, as a representative on drug core and lifecycle teams, and within Technical Operations, and have the ability to successfully manage multiple teams as needed. The PTL will be experienced leader in diagnostic device development and commercialization across multiple functions, and will have built a reputation as a highly sought after cross-functional team leader and program manager. Overall, the expectation for this role is of impactful matrix leadership, communication, and delivery of the device portfolio, as a critical element of Achaogen’s drug portfolio.
Responsible for delivery of diagnostic device programs
Lead and manage diagnostic development core teams and lifecycle teams for programs from early stage development to commercial. Sets strategic direction for projects.
Represent all device-related aspects of the program to the Development Core Team and/or Lifecycle Team and other executive leadership forums as appropriate. Serve as the primary liaison between Development Core Team/Lifecycle Team, leadership, and project team members. Collaborate with functional leaders in research, development, clinical, quality, regulatory, and commercial, as well as with external partners through JPT and JSC structures. Identify opportunities and remove obstacles.
Oversee execution of integrated project plans including milestones, timelines, resources and budgets.
Accountable for availability of clinical supplies, timely and complete submission of regulatory filings and development of devices necessary for drug program success within a “matrix” structure.
Responsible for leading selection of external device partners, and technical oversight of external diagnostic programs. Responsible for effective collaboration with external development and manufacturing partners.
Proactively develop and manage project timeline, risks, budget and resources. Drive project related decisions to ensure teams are successful in achieving their goals and team milestones.
Author and review of relevant sections of clinical protocols and regulatory filings, interact with global regulatory agencies.
Thrive in the presence of ambiguity; leverage existing and develop new skills and knowledge to meet program needs as they arise.
Minimum 10 years of experience in diagnostic development technical development and leadership (Class II/III preferred)
Experience performing due diligence of vendors, technologies, and assays for ability to commercialize
Experience authoring diagnostic portions of clinical protocols, drug study reports, regulatory submissions
Strong verbal and written communication skills
Ability to think strategically to find solutions and mitigation strategies to complex problems and then execute them
Basic understanding of IP, contracting terms and provisions
Significant project and/or functional leadership experience
Demonstrated knowledge of project management fundamentals
Experience in device development through commercial
BS, MS or PhD, Molecular biology, biochemistry, chemistry, engineering or related degree; MBA a plus.
Preferred Additional Skills:
Extensive working knowledge of current state-of-the art diagnostic technologies
Extensive knowledge and understanding of ISO13485, GMP and design controls
Significant experience writing, reviewing and overseeing execution of verification and validation protocols
Prior experience with IDE, 510(k), PMA submissions and approvals; experience participating in regulatory meetings (diagnostic and drug)
Experience performing due diligence and auditing of vendors and technologies
Experience establishing productive, collaborative relationships with external partners
Collaborative approach to successfully lead and participate in cross-functional teams, with strong influencing skills and proven ability to negotiate and build consensus.
Strong business acumen and strategic agility driven by solid analytical thinking.
Proven project management skills - able to anticipate problems at project level and put mitigation plans into place
Extensive experience in clinical development process and validation in an industry setting
Excellent verbal/written communication and presentation skills
Able to thrive in the presence of ambiguity, and to both leverage existing and develop new skills and knowledge to meet program needs as they arise
Demonstrated success in fast paced entrepreneurial environment
Committed to the values of integrity, accountability, transparency, scientific rigor and drive
Current US work authorization required
Able to travel domestically and internationally