Director Clinical Development & Medical Affairs

Summary

The Director, Clinical Development & Medical Affairs leads a global team and serves as the senior clinical partner to R&D, Marketing, Regulatory, Human Factors, Market Access and New Ventures. The role is responsible for strategic leadership and scientific depth setting the direction and engaging personally on the clinical questions that matter most. Responsible for developing Clinical Development and Medical Affairs into an upstream strategic capability, that shapes products, claims, evidence strategies and portfolio choices from the first decisions onward.

Hollister Incorporated operates in a hybrid work environment. Associates are expected to come into the office in Libertyville, IL a minimum of 4 days per week.

Responsibilities

Clinical and evidence strategy

• Build integrated evidence roadmaps for priority products, platforms and therapy areas: the clinical questions, outcomes, endpoints and studies, in what order and why.
• Distinguish clearly between the evidence needed for regulatory clearance and the evidence needed to create clinical conviction, and plan for the second.
• Pull evidence planning into discovery and product definition, while the design is still be shaped.
• Name the gaps in our current evidence base and rank them by what closing them would unlock.

Product and portfolio influence

• Bring outside reality in: clinical practice, care pathways, unmet need, outcomes, emerging science.
• Test concepts, target populations, claims and value propositions against the clinical rationale, and show what would make a thin one defensible.
• Move teams from feature differentiation toward differentiation a clinician would recognize as meaningful.
• Evaluate new technologies and adjacent spaces through a clinical and evidence lens.

Clinical development and study execution

• Own design and delivery of pre-market and post-market studies: protocols, endpoints, statistical approach, investigators, sites.
• Oversee clinical operations, CROs, vendors, budgets, timelines and data quality.
• Hold studies to GCP, ISO 14155, FDA and EU MDR requirements, and support notified body engagement.
• Build lean and scalable clinical development discipline, without unnecessary bureaucracy.

Claims and substantiation

• Partner with Marketing, R&D, Regulatory and Legal to develop claims that are clinically meaningful and scientifically defensible.
• Design the evidence around the claims and outcomes that matter most to patients, clinicians and the business — early enough that the ambitious claim is still reachable.
• Turn evidence into clinical narratives that engineers, marketers, clinicians and regulators each understand.

Build real-world and post-market evidence capability

• Define a fit-for-purpose RWE strategy across registries, observational studies, patient-reported outcomes, existing datasets and post-market studies.
• Make post-market clinical follow-up (PMCF) as a genuine source of product and market insight.
• Partner with Market Access and health economics where clinical and economic evidence meet.

External clinical network and scientific communication

• Build relationships with leading clinicians, WOC and specialist nurses, researchers, rehabilitation centers and professional societies, and represent Hollister in scientific forums.
• Shape the KOL and advisory board strategy with the relevant functions.
• Develop clinician and nurse panels our teams can reach in days, not quarters, to pressure-test needs, concepts, claims and evidence plans.
• Set the publication and congress strategy and get meaningful evidence into the literature.
• Stay current with practice, guidelines, literature and competitor evidence, and translate what it means for our portfolio.

Leadership of Clinical Development Organization

• Lead a global team and add the strategic, scientific and analytical capability required to support both today's portfolio and future growth.
• Establish clear expectations, standards, roles, and ways of working.
• Build a culture of scientific rigor, curiosity, constructive challenge, and external orientation.

Essential Functions of the Role

Education & Work Requirements

Education & Work Preferences

An advanced clinical or scientific degree is strongly preferred, including MD, PhD, PharmD, DNP or another advanced nursing or clinical degree, or an MS or MPH paired with deep clinical development experience.

A physician degree is not required. More important is strong clinical credibility, scientific judgment, evidence-development expertise, and the ability to engage as a peer with clinicians, researchers, and senior business leaders.

Experience in building or substantially strengthened an evidence strategy, not only executed studies, and can walk us through a roadmap you wrote and what it changed.

Designed and overseen pre-market and post-market device studies through to completion.

Working command of GCP, ISO 14155, FDA and EU MDR clinical requirements.

Real-world evidence in practice: registries, observational research, patient-reported outcomes or secondary data.

Translated evidence into product claims, peer-reviewed publications, or a change in clinical practice.

Built and actively used external clinical networks: KOLs, investigators, professional societies.

People leadership experience 3+ years

Preferred: Experience with products used in chronic care or other patient-managed conditions is advantageous but not required.

Competencies