Companion Diagnostics Project Leader

8 months ago

Newcastle upon Tyne, United Kingdom Leica Biosystems Full time

Leica Biosystems’ mission of “Advancing Cancer Diagnostics, Improving Lives” is at the heart of our corporate culture. We’re a global leader in cancer diagnostics with the most comprehensive portfolio from biopsy to diagnosis. Our easy-to-use and consistently reliable offerings help improve workflow efficiency and diagnostic confidence. Our associates know that every moment matters when it comes to cancer diagnostics. When you come to work, you’re helping develop solutions that enable accurate diagnoses to turn anxiety into answers. Join our diverse, global team of talented people, and be inspired to grow every day.

Leica Biosystems is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we’re working at the pace of change to improve patient lives with diagnostic tools that address the world’s biggest health challenges.

The Companion Diagnostics Project Leader is responsible for ensuring that Leica Biosystems is leading the way in companion diagnostic product development. You will be externally facing to pharmaceutical industry partners and internally facing to the LBS assay development team. This is a senior role, responsible for critical decision-making to ensure successful program completion.

At Leica Biosystems, our vision is to advance cancer diagnostics and improve lives. You will be a part of the Companion Diagnostics team and report to the Sr. Director, Pharma Partnerships responsible for successful co-development of CDx products_. _If you thrive in a fast-paced, high impact, and customer focused role and want to work to build a world-class diagnostics organization — read on.

**In this role, you will have the opportunity to**:

- Be accountable for end-to-end delivery of companion diagnostics from assay development kick-off to coordinated commercialization with our Pharma partners.
- Act as the integrator for CDx development projects; lead cross functional matrixed teams who are not direct reports but for which you will have direct accountability to lead and achieve program/project objectives:

- Manage CDx Development program with Pharma partner, internal cross functional team, and LBS Executives, with the goal of ensuring alignment of critical milestones throughout the therapy and CDx co-development lifecycle.
- Act as the primary interface with multiple internal and external stakeholders; ensure that various departments, processes, and systems work cohesively to deliver on defined project goals/customer milestones.
- Create self-initiated assignments, independently determine priorities, both tactical and strategic, and operate with a high degree of autonomy.
- Partner with the CDx Business Development team to exchange and clarify information with Pharma partners or others outside the organization as needed as well as represent the organization in providing solutions on projects.

**The essential requirements of the job include**:

- Demonstrated experience delivering complex projects by leading through influence and collaborating with across cross-functional teams towards achieving strategic objectives.
- Proven knowledge of the drug and diagnostic development processes (clinical trials, efficacy

endpoints, biomarker testing), including experience supporting global registrational clinical trials and commercialization.
- Ability to drive a customer focused culture by continuously gathering and analyzing customer feedback:

- Effective communication and collaboration skills to align team with a customer centric vision.
- Excellent problem-solving skills to address customer issues.
- Broad knowledge and understanding of the CDx competitive landscape (novel and established clinical and diagnostic assay technologies) and in global IVD regulatory considerations including US/EU/China
- Exceptional interpersonal and communication skills to build strong relationships and influence both internal and external stakeholders.
- Strategic thinker, agile, and sound decision maker; able to adapt to complex internal and external challenges and deliver results.

**It would be a plus if you also possess previous experience in**:

- Understanding of the and current regulations preferred.
- Proven CDx experience - owned the successful launch of CDx
- Broad network of KOLs in oncology space

At Leica Biosystems we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, hybrid working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a hybrid work arrangement in which you can work part-time at the Company location identified above and part-time remotely from your home. Additional information about this hybrid work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Leica Biosystems can provide.

When you join us, you’ll also be joining Danaher’s global organization,

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