Director, Clinical Strategy and Trial Excellence

RQM+ is The MedTech CRO, accelerating innovation to patient impact. Our tailored solutions deliver regulatory and quality expertise, FDA-recognized laboratory services, clinical trials, and reimbursement strategies across device types and therapeutic areas to bring life-changing technologies to patients — faster, safer, better.

We don’t make MedTech. We make MedTech happen.

Our experienced teams are cohesive, collaborative, and proactive, constantly seeking to improve and evolve while remaining laser-focused on customer success. RQM+ elevates the MedTech experience through best-in-class service and clear, concise communication. We serve as an extension of our customers establishing and maintaining excellent client and site relationships and providing direct access to our technology platforms for real-time data and study transparency.

Job Summary:

The Director, Clinical Strategy and Trial Excellence will be the public face of RQM+ clinical trials. Working hand in hand with Clinical Trial Ops, the director will shape clinical strategy we present to customers, build RQM+’s reputation for excellence in the trials space, and make sure what we propose is what Ops can deliver, so studies start well and stay on track after hand-off. The Director will also play a key role in expanding and growing RQM+’s clinical trials business. This is a highly visible, commercial, customer-facing opportunity for an experienced MedTech clinical trial operations leader looking to leverage their expertise in a strategic business development capacity.

In this role, you will serve as the clinical trials subject matter expert alongside our Business Development team, bringing credibility, expertise, and operational insight to prospective customer engagements. While BD identifies and qualifies opportunities, you will help translate customer needs into tailored clinical trial solutions—showcasing RQM+’s capabilities, demonstrating how we would successfully execute a study, and helping convert opportunities into new business. You will share accountability for achieving the company’s clinical trials signings goals.

You will be part of RQM+’s Centers of Excellence, within Commercial Operations, reporting directly to the SVP, Head of RQM+ Centers of Excellence. This role is focused on driving growth and winning new business, with any billable study delivery to be defined with the SVP, Head of RQM+ Centers of Excellence, as the role and team grow. Your primary focus will be leveraging your clinical expertise to build customer confidence, shape solutions, and help secure new clinical trial engagements.

Your primary measure is RQM+'s total clinical trials signings against the annual goal. Your variable compensation is tied to it.

Supporting measures are set with the SVP, Head of RQM+ Centers of Excellence. They will include the share of trial pursuits you engage before the proposal goes out, win rate on engaged versus unengaged pursuits, startup milestone adherence on awarded studies, a hand-off quality score from Clinical Trial Ops, sponsor feedback at early milestones, and repeat or expanded business from awarded studies. Targets and baselines are set with the SVP, Head of RQM+ Centers of Excellence, within 90 days of your start.

Primary Responsibilities:

Win business

• Help BD win clinical trials work against our annual signings goal, as part of the team accountable for it.
• Join pursuits once BD has found and qualified the opportunity and help shape the plan to win it.
• Talk customers through our clinical trials experience, what we do and how we do it.
• Lead the operational conversation in discovery calls, capability presentations and bid defense meetings.
• Earn the trust of sponsor clinical, regulatory and executive teams as RQM+'s voice on study execution.

Shape clinical strategy

• Present how we will run the study: site strategy, feasibility and enrollment, monitoring model, timelines and risk mitigation.
• Lead the Startup Risk Review and Startup Risk Map on qualified trial pursuits before the proposal goes out, following the engagement process agreed with BD, so sponsors see how the study will start on time.
• Turn sponsor needs, protocols and RFPs into a clear scope and the operational assumptions behind our budgets, working with Proposals & Contracts and Trials delivery on proposals that win and can be delivered as sold.

Partner with Clinical Ops through and after hand-off

• Hand awarded studies to Clinical Trial Ops with a standard hand-off package that documents scope, assumptions and customer commitments, and obtain Trial Ops acceptance.
• Stay available to Clinical Trial Ops through study kickoff, for a window agreed with the Head of Clinical Trials.
• Run a hand-off health check with Clinical Trial Ops at agreed milestones, acting as the sponsor’s strategic contact and escalation partner while Ops owns delivery, and raise issues early so they do not threaten timelines or sponsor confidence.

Build RQM+’s reputation for trial excellence

• Tap into your industry network to raise RQM+'s profile with sponsors, investigators and sites.
• Serve as the named external voice of RQM+ clinical trials: attend industry conferences and, where it fits, speak at them, and lead lunch-and-learns, webinars and LinkedIn Live sessions.
• Help build partnerships with pre-clinical labs, decentralized trial providers, KOLs, prominent PIs, key sites, and other service providers that extend what RQM+ can offer, with assistance in review of agreements with RQM+ legal.
• Create thought leadership, such as articles, white papers, video and a startup benchmark, with Marketing.
• Partner with the other Centers of Excellence on pursuits that lead to a clinical study.
• Equip BD with trials talking points, competitive positioning and customer stories.
• Bring market and win/loss insight back to Commercial and Trials leadership.
• Keep your activity on opportunities current in Salesforce.

Position Guardrails

• Make no commitment on timelines, fees or fees at risk without sign-off from Legal, Finance and Trials leadership.
• Own no customer accounts. BD remains the account owner.
• Perform billable delivery work where applicable, in discussion with the SVP, Head of RQM+ Centers of Excellence.

Success in the First Year

• By 90 days: the pursuit engagement process with BD, and the hand-off package and health check with Clinical Trial Ops, are agreed, and baselines for the supporting measures are set.
• By 6 months: the Startup Risk Review and Startup Risk Map are in use on new trial pursuits, and the first hand-off health checks are complete with Trial Ops.
• By 12 months: engaged and unengaged pursuits are compared in Salesforce, and awarded studies are measured on startup milestone adherence and sponsor feedback at early milestones.

Education/Work Experience/Requirements:

• 12+ years in clinical trial operations, such as project management, clinical operations or study leadership.
• Hands-on experience running medical device trials, including IDE studies and EU MDR clinical investigations.
• Working knowledge of trial budgets, feasibility, site start-up and enrollment planning.
• Comfort in front of customers and confidence presenting, from sponsor executive meetings to conference sessions and webinars, and explaining operational trade-offs in business terms.
• A real interest in a commercial role, and comfort being measured on sales results.
• Bachelor's degree in life sciences, nursing, engineering or a related field.
• Working knowledge of ISO 14155 and GCP.
• Experience with trial startup, including site activation, IRB and ethics committee and regulatory submissions, and site budget and contract negotiation.

Preferred

• Operations experience at a MedTech CRO or medical device sponsor.
• Trial experience in cardiovascular, neurovascular or neuromodulation devices.
• Prior involvement in proposals, bid defenses or client development.
• An established network across device sponsors, investigators and sites.

Behaviors: Action-Oriented, Approachability, Building Effective Teams, Business Acumen, Composure, Courage (Managerial), Customer Focus, Decision Quality, Drive for Results, Informing, Integrity & Trust, Interpersonal Savvy, Planning, Presentation Skills

Supervisory Responsibilities: None for now, with the option to add direct reports as the role succeeds and the team grows.

Work Environment & Physical Requirements:

This is a remote position. The employee is expected to maintain a dedicated, distraction-free home workspace with reliable high-speed internet access. Core working hours are determined by role responsibilities, client expectations, and business needs. Travel of up to 30% to 40% of working time is anticipated, for sponsor meetings and industry conferences.

These requirements reflect what's typically needed to perform the core functions of this role. If you require an accommodation to perform any aspect of this position, please let us know and we're happy to discuss options.

Being an industry leader in Medtech is just the beginning for RQM+. We consider our employees our biggest asset and we invest heavily in ongoing learning and development. Providing a rewarding place to work is rooted deep in our core values. From an industry leading compensation package to a deeply engrained focus on work life balance, RQM+ has a unique offering for regulatory and quality professionals. At RQM+, you are not just another employee, you are a member of RQM+ family. Make your impact today!

We invite you to apply if you have an interest in learning more about our organization and beginning your journey with us.

Job Opportunity Verification:

At RQM+, we prioritize the security of our job applicants. To ensure a safe application process:

• All legitimate RQM+ job opportunities are listed on our official careers page: rqmplus.com/careers
• Every candidate going through the interview process will participate in a voice and/or video interview.
• Exercise caution with unsolicited job offers or requests for sensitive information.