Gilbert Meher are currently working with an innovative biotechnology company who are using machine learning to make breakthroughs in disease diagnosis and management. Recent research success and fundraising has enabled them to transition to the commercial diagnostics space, and as a result they are seeking a Director of Program Management.
My client are seeking a driven individual with a proven track-record leading Program Management in a biotechnology environment. The successful candidate will plan and execute a business-critical program, spearheading the development and launch of a pioneering cancer screening platform.
- Driving the cross-functional product development program of an In Vitro Diagnostic cancer screening test.
- Overseeing of all phases of the product development process from Concept to Launch, with excellent understanding of Design Control principles.
- Managing resources to deliver program status, decision trade-offs, or priorities to senior executive leadership.
- Leading dependent projects needed to deliver against integrated plans within budget and timeline constraints, building corresponding project team.
- Promoting proactive communication in collaboration with functional directors, assuring company integration to achieve milestones.
- Development and implementation of KPIs including effectiveness of technical strategies, regulatory pathways, clinical development progress, project execution and product development risks.
- Leading a sustainable program function and cross-functional training to coach and partner with functions on the use of Project Management methodologies.
- Organising regular team meetings to drive progress, track and mitigate risks, resolve/escalate issues, and review action items.
- >10 years’ biotechnology experience – Diagnostics/IVD preferred but Medical Devices also acceptable:
- The ideal candidate has both IVD and Laboratory Testing experience, with the IVD development preferred.
- Assay development experience required, with an understanding of systems development desirable.
- Experience of product development and launch in an FDA regulated environment – ideally PMA submission but 510k etc. also acceptable.
- A proven understanding of early stage development – from feasibility testing through to protocol development and clinical trials.
- A proven track-record of driving project success, with demonstrated deliverables in relation to product development and launch.
- A strong cross-functional leader with a hands-on approach, with excellent decision making and prioritising ability.
- The ability to integrate existing teams to drive towards new product development and launch, with a good understanding of the challenges involved with navigating a new business area.
- PhD educated in Biological Sciences.
- Certification in Program Management (eg. PMP) and experience using resource management tools.
- Desired technical understanding of Cancer, Systems or Computational Biology and regulated software product development.
The position is to be based in San Francisco, California and will support relocation. If you are interested please apply directly.
Whilst we may not be able to respond personally to each applicant, we appreciate the time you have taken to consider and apply for a new role with us. If you have not heard from us within 4 weeks, then on this occasion your application has not been successful.