Chief Clinical Dev. & Ops Officer

Position Summary

We are seeking a high-performing enterprise clinical leader to lead and advance Global Clinical Affairs across all Danaher Diagnostics (DHR Dx) operating companies. Reporting to the Diagnostics Platform CIO, the VP is a member of an executive science and technology leadership team, accountable for the clinical evidence strategies that support the development, approval, launch, and lifecycle management of novel diagnostic products, including those using machine learning and AI.

The incumbent will translate disease strategy, in partnership with OpCo R&D and Global Regulatory Affairs, into rigorous, regulatory-ready clinical evidence. The leader will operate through the existing OpCo-integrated Clinical Research model, working closely with the OpCo R&D, Regulatory Affairs, Quality, and QRC leaders who own program execution, quality oversight, and associated budgets.

The VP will also advance clinical governance so that material clinical decisions, risks, and changes are visible to the appropriate OpCo and platform leadership.

The enterprise leader will operate in a matrix with other CIO functions and relevant OpCo L1 leaders. The broader Clinical Affairs organization will remain anchored in its existing OpCo and shared-services responsibilities. Over time, will assess and strengthen the seniority, clinical judgment, scientific depth, and external credibility required in critical leadership and clinical-science roles to support Danaher Diagnostics’ disease-leadership ambition.

Essential Job Responsibilities

Disease Leadership and Clinical Evidence Strategy

Translate disease strategy: translate disease-area strategies and unmet clinical needs into fit-for-purpose clinical evidence plans across pre-market development, product approval, launch, adoption, and post-market lifecycle management.

Set and own a clear, prioritized enterprise clinical evidence agenda in the critical disease areas, connecting evidence generation to patient pathways, clinical utility, guideline positioning, and adoption barriers.

Provide senior clinical judgment on: study design, endpoints, comparators, claims support, evidence sufficiency, and protocol quality across a broad range of IVD products and technologies, including ML and AI.

Integrate disease-area Chief Scientific Officers as technical disease experts, alongside relevant OpCo R&D, Regulatory Affairs, Quality, and Medical leaders, into development strategy, regulatory evidence design, endpoint selection, and critical clinical decisions. Ensure that disease expertise informs evidence plans without displacing the accountability of the responsible OpCo teams and functions.

Shape and defend in partnership with regulatory the clinical evidence position with regulators, notified bodies, and health-technology assessment bodies where clinical input is required.

Champion coherent clinical claims and intended-use strategies that withstand regulatory, payer, and peer-review scrutiny across geographies.

Monitor emerging clinical, scientific, and regulatory evidence trends in the critical disease areas and translate them into anticipatory evidence and portfolio choices.

Prioritize evidence-generation approaches that differentiate the portfolio, including clinical utility, health-economic, and outcomes studies where they build durable advantage.

Clinical Science Team Building and External Leadership

Assess the maturity, seniority, and scientific credibility of the clinical science teams; today's teams may be more operational or junior than the mandate requires.

Strengthen and elevate these teams so their members become recognized leaders in their disease space, capable of independent scientific judgment rather than task execution.

Enable and sponsor external engagement with core clinical leaders, KOLs, academic centers, and consortia in the critical disease areas, where relevant for development positioning Danaher Diagnostics as a credible scientific partner.

Drive a targeted upgrade of scientific talent where current depth does not match the disease-leadership ambition, recruiting recognized experts as needed.

Create development pathways, mentoring, and stretch assignments that grow the next generation of clinical and scientific leaders.

Establish succession plans that create a resilient pipeline of senior clinical and scientific leadership across disease areas.

Matrix Partnership Across CIO Functions

At the enterprise-leader level, build effective connectivity across CIO functions and relevant OpCo L1 stakeholders, while preserving the primary day-to-day focus and existing reporting relationships of the OpCo-integrated Clinical Research teams.

Partner with Medical Affairs to advance a clear Clinical Affairs–Medical Affairs handshake, using complementary expertise and medical insights to strengthen clinical design, evidence strategy, and disease leadership, with clear interfaces and accountability for execution.

Partner with Data & AI to embed data strategy, real-world evidence, advanced analytics, and validated AI/ML methods into clinical evidence generation and study design.

Partner with Value & Access (V&A) to ensure evidence plans anticipate reimbursement, health-economics, and market-access requirements from the outset.

Partner with the disease franchises to align clinical priorities with franchise strategy, portfolio sequencing, and disease-leadership objectives.

Partner with the disease-area CSOs so that technical disease expertise is embedded in regulatory design, endpoint selection, and clinical leadership decisions.

Translate evolving enterprise priorities into clear implications for Clinical Affairs, while assessing changes through the existing OpCo operating model and established functional accountabilities.

Integration with Operating Company R&D, Regulatory Affairs, Quality, and QRC Leadership

Preserve the deep integration of Clinical Research within the OpCos, including its partnerships with R&D, Regulatory Affairs, Quality, and QRC leadership, and its connection to OpCo program and clinical-trial budgets. Ensure clinical evidence strategy is planned and executed within this established operating model rather than through a parallel platform structure.

Build a trusted partnership with R&D leaders so clinical evidence needs, timelines, and trade-offs are reflected in program plans and investment decisions.

Secure early clinical input into product definition, design inputs, and program planning so evidence requirements are anticipated rather than retrofitted.

Ensure clinical resource and budget needs are visible and prioritized within OpCo program planning cycles.

Serve as the clinical voice in phase-gate and program-review decisions across the operating companies.

·       Strengthen the partnership with Regulatory Affairs so that clinical evidence requirements, regulatory strategy, intended use, claims, and submission needs are aligned early and remain aligned as programs evolve.

·       Partner with Quality leaders to strengthen QMS compliance for Clinical Affairs, inspection readiness, clinical-process consistency, and the timely identification and remediation of systemic quality risks.

Define clear, cross-functional accountability for clinical protocol development and approval. Clinical Science should lead or co-lead the scientific and clinical design of protocols where appropriate, working with R&D, Regulatory Affairs, Quality, Biostatistics, Medical Affairs, and disease-area CSOs to ensure that protocols are scientifically rigorous, operationally feasible, regulatory-ready, and aligned with the intended use and evidence strategy.

Governance, Decision Elevation, and CIO Visibility

Map the existing clinical governance models across OpCos and lead the ongoing harmonization of standards, decision criteria, information flows, and escalation expectations where this improves quality, consistency, or enterprise visibility, while preserving appropriate OpCo governance and accountability.

Ensure that material clinical decisions, changes, evidence gaps, quality risks, and disease-leadership inflection points are considered by the appropriate OpCo L1 leaders as well as franchise CSOs when applicable and elevated to the CIO when their impact warrants.

Create a consistent portfolio view of clinical risks, evidence gaps, dependencies, and decisions so issues surface early enough to act.

In partnership with OpCo leaders and CIO peers, establish clear thresholds for decisions that remain within existing OpCo governance and those that require additional capability visibility or CIO review because of material clinical, regulatory, quality, reputational, or portfolio implications.

Provide transparent reporting on clinical program status, quality, and risk to the CIO and enterprise leadership.

OpCo L1 Partnerships

• Establish strong OpCo L1 partnerships with Regulatory Affairs and Quality leaders and with Chief Medical Officers, so evidence, regulatory, quality, and medical decisions are integrated early.
• Set clinical standards and expectations that strengthen the OpCo leadership system rather than bypassing accountable OpCo leaders.
• Partner with each OpCo leadership team to align clinical priorities, capability, capacity, and resourcing within established OpCo planning and budget processes.
• Ensure that OpCo-integrated Clinical Research has an effective and sufficiently senior voice within OpCo leadership and governance through strong dotted-line partnerships with Regulatory Affairs, Quality, and Medical leadership. Clarify the accountability of these leaders for representing material clinical priorities, risks, resource needs, and decisions, and ensure appropriate escalation to OpCo L1 and CIO leadership when required.

Differentiated Operating Models

• Recognize and lead the distinct operating models within Clinical Affairs: OpCo-integrated Clinical Research teams funded through OpCo budgets, and enablement or shared-services capabilities funded and governed through platform arrangements and MOUs.
• Clarify the accountabilities, service expectations, funding mechanisms, and performance measures appropriate to each model rather than applying a single structure across the full organization.
• Ensure shared capabilities create scale, consistency, and specialist depth while remaining responsive to OpCo program requirements and accountable business owners.

Sourcing Strategy and CRO / Partner Oversight

• Establish a repeatable sourcing framework to determine which clinical capabilities and activities should be retained internally, delivered through shared services, or outsourced to CROs and other partners, based on strategic importance, internal capability, capacity, quality, cost, speed, and required control.
• Lead CRO and external partnership oversight where work is outsourced, including selection, contracting inputs, quality, performance, and relationship governance.
• Ensure that accountability for outsourced work remains clearly assigned internally and is not transferred to the CRO or external partner.
• Build appropriate internal sponsor capability for CRO selection, study oversight, issue escalation, quality management, and partner performance review.
• Define the internal capabilities that must be retained for strategic control and the work that can be flexibly scaled through partners.
• Set performance standards, metrics, and escalation routes for CRO partners to protect quality, timelines, and compliance.

Talent, Seniority, and Organization Building

• Assess whether critical clinical leadership roles have the seniority, scope, scientific depth, and decision authority required for their accountabilities, and address identified gaps through development, role clarification, succession, selective recruitment, or organization design.
• Differentiate leadership roles that require deep disease and clinical-science credibility from roles primarily accountable for operational delivery, and ensure both are appropriately designed, staffed, and connected.
• Develop clinical-science teams from strong technical and operational contributors into increasingly independent clinical leaders, with the scientific judgment and external credibility appropriate to their disease areas and roles.
• Cultivate a positive, high-performing environment that reflects company values and develops associates.
• Shape an organization design and operating model that scales with the portfolio and the disease-leadership ambition.

Functional Accountability and Executional Excellence

• Provide enterprise functional leadership for Clinical Study Development and Management, Biostatistics, Medical Writing, Clinical Compliance, and Data Management across DHR Dx, with accountability exercised through the applicable OpCo-integrated, direct-report, and shared-services operating models.
• Leverage the Danaher Business System to deliver predictable, high-quality clinical programs through milestones, quality metrics, resource prioritization, risk management, and transparent escalation.
• Ensure clinical systems are established and maintained in accordance with applicable clinical standards and worldwide requirements.
• Drive a culture of quality, inspection-readiness, and continuous improvement across the clinical organization.

Digital and AI Enablement

• Identify, evaluate, and scale enabling technologies (RIMS, CTMS, AI, LLM, automation, advanced analytics) to strengthen evidence generation and organizational efficiency, while ensuring governance, data integrity, validation, privacy, security, and regulatory compliance.
• Champion responsible, validated use of AI/ML in clinical workflows, with appropriate human oversight and documentation.

Minimum Requirements

Education and Experience

• An MD, PhD, or relevant MSc is required. Candidates with an MSc must bring substantial, directly relevant leadership experience in IVD Clinical Affairs or Clinical Operations and a demonstrated record of scientific, regulatory, and operational impact.
• Typically 18+ years of progressive experience in Clinical Affairs, Clinical Development, or Clinical Operations, including substantial experience in IVD or medical-device development, global evidence generation, and clinical compliance.
• 8+ years as a successful senior people leader managing diverse, geographically dispersed teams.
• Professional designations are not required, but training or certificates in clinical research, clinical compliance, quality, or continuous improvement are a plus (e.g., CCRA, CCRC, Six Sigma, Lean).

Knowledge and Skills

• Subject-matter expertise in Global Clinical Affairs within diagnostics, medical device, or pharma, including clinical study design, execution, evidence generation, and clinical compliance; in-depth IVD knowledge strongly preferred.
• Demonstrated ability to translate disease strategy into evidence plans and to judge clinical quality, evidence sufficiency, and claims logic independently.
• Recognized clinical/scientific credibility with the ability to build teams that engage credibly with external clinical leaders in critical disease areas.
• Track record of leading global, matrixed organizations through accountable local leaders and of partnering across medical, data/AI, access, and franchise functions.
• Experience building and upgrading senior clinical and scientific talent, and integrating disease scientific experts into regulatory and trial design.
• Experience making internal-versus-CRO sourcing decisions and governing CRO and external partnerships.
• In-depth knowledge of global clinical research standards, guidelines, and compliance requirements governing diagnostic and device development.
• Fluency with digital and AI tools relevant to clinical evidence generation, with the judgment to apply them responsibly and compliantly.

Critical Competencies and Attributes

• Strategic thinker able to address complex, ambiguous situations and connect evidence choices to disease leadership and portfolio outcomes.
• Decisive leader with the courage to surface difficult issues early and resolve them through governance rather than central intervention.
• Able to manage matrices, influence peers and senior leaders, and build partnership atmospheres across R&D, RA/QA, Medical, Data & AI, V&A, and the franchises.
• A talent builder who can raise the seniority and external credibility of scientific teams and develop future clinical leaders.
• Strong external presence and scientific credibility to represent the company with clinical experts, regulators, and partners.
• Digital and AI fluency, with the judgment to distinguish meaningful use cases from trends and to champion ethical, secure, and compliant adoption.
• Unquestionable integrity and character; willing and able to travel as required.

Note: The statements in this description represent typical elements and general work performed. They are not intended to be an exhaustive list of all responsibilities, duties, and skills for this role.

Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

For more information, visit www.danaher.com .

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