Company: Wave Strategy
Location: Cleveland, OH (Hybrid)
Engagement: Part-Time / Contract

About Wave Strategy

Wave Strategy partners with AMCs and TTOs, industry, investors, economic development organizations, accelerators, and international clients to deliver strategic guidance at the intersection of science, innovation, and commercialization. We specialize in emerging therapeutics - including cell and gene therapies - to help clients anticipate scientific inflection points, accelerate innovation, identify commercial opportunities and build resilient strategic plans.

Role Overview

Wave Strategy is seeking a seasoned Cell & Gene Therapy Consultant (Part Time) to serve as a Subject Matter Expert (SME) across client engagements. This role supports scientific, clinical, CMC, regulatory, and commercial strategy workstreams by providing expert insights that deepen project quality and strengthen recommendations to clients.

This is an ideal opportunity for experienced biopharma professionals with business development backgrounds who want to contribute high‑impact expertise on a flexible schedule.

Key Responsibilities

Scientific & Technical Expertise

• Provide expert guidance on commercial viability of emerging cell & gene therapy technologies (in various stages of development), platforms, mechanisms of action, and define competitive landscapes.

• Review and interpret scientific literature, pipeline data, and clinical trial results to support strategic assessments.

• Advise on feasibility, risks, and differentiation for AAV, lentiviral, mRNA, CRISPR/editing tools, autologous/allogeneic cell therapy, and other modalities.

Strategic Project Support

• Partner with Wave Strategy consultants to develop scientific and commercial insights, scenario plans, and client recommendations.

• Support opportunity assessments, market analyses, market definition, target product profiles, due diligence evaluations, financial term sheets, and portfolio strategy.

• Advise as appropriate on deal terms and agreement structure for development and commercial agreements

• Participate in working sessions and contribute to high-level synthesis and development of strategic positioning.

Regulatory, Clinical, & CMC Guidance

• Provide perspective on evolving regulatory frameworks (FDA, EMA) for advanced therapies.

• Advise on clinical development strategies, patient selection considerations, safety challenges, and post‑approval requirements.

• Offer insights into manufacturing scalability, CMC risks, analytical challenges, and comparability expectations for CGT products.

• Identify various vendors for development and manufacturing

Client Engagement

• Participate in client discussions, scientific advisory meetings, and workshops as a subject matter expert.

• Communicate complex scientific topics clearly to diverse audiences, including strategy consultants, investors, development/commercial partners and business leaders.

• Support proposal development and thought leadership as needed.

• Introduce client, as appropriate, to key people in the CGT network

Qualifications

• Advanced degree in life sciences (PhD, MD, or PharmD preferred).

• 7–10+ years experience in cell & gene therapy research, clinical development, CMC, regulatory affairs, or medical affairs.

• Demonstrated expertise in at least one major CGT domain (e.g., AAV engineering, CAR‑T, gene editing, process development).

• Prior consulting or advisory experience is a plus.

• Strong ability to translate technical insights into strategic implications and commercial opportunities.

• Excellent communication skills and comfort working in a collaborative, fast-paced environment.

Time Commitment

• Flexible part‑time engagement (5–20 hours/week depending on project load).

• Workload varies by project and can be distributed to align with the expert’s bandwidth.

Why Join Wave Strategy?

• Work alongside top-tier scientific and business strategists shaping the future of advanced therapies.

• Highly flexible consulting model - ideal for academics, industry leaders, and independent scientists.

• Opportunities to influence high-impact decisions across biotech, pharma, and investment sectors.

Company: Wave Strategy
Location: Cleveland, OH (Hybrid)
Engagement: Part-Time / Contract

About Wave Strategy

Wave Strategy partners with AMCs and TTOs, industry, investors, economic development organizations, accelerators, and international clients to deliver strategic guidance at the intersection of science, innovation, and commercialization. We specialize in medical device advisory to help clients anticipate milestones, accelerate innovation, identify commercial opportunities and build resilient strategic plans.

Role Overview

Wave Strategy is seeking an experienced Medical Device Consultant / Subject Matter Expert (Part Time) to support strategic engagements across the healthcare innovation ecosystem. This role brings deep technical, regulatory, clinical, business development and commercialization insights to help evaluate technologies, shape development pathways, and inform high-impact client recommendations.

This role is ideal for industry veterans, regulatory specialists, engineers, clinical and business development leaders who want to contribute expertise on a flexible schedule.

Key Responsibilities

Technical & Product Expertise

• Provide expert insight across a range of medical device categories, including diagnostic/imaging devices, medication delivery/therapeutic devices, surgical tools, digital health tools, SaMD, wearables, and implantable technologies

• Review and assess product designs, engineering considerations, usability, risk profiles, and differentiation vs. competitive solutions.

• Evaluate technology readiness, development hurdles, and feasibility across early- and late-stage devices.

• Identify potential vendors and development partners

Strategic Project Support

• Partner with Wave Strategy consultants to deliver analyses, strategic assessments, and detailed client recommendations.

• Contribute insights to market scans, opportunity assessments, voice-of-customer research, and product value proposition development.

• Assist in due diligence efforts for investors, AMCs/TTOs, or industry partners evaluating new device innovations.

• Advise, as appropriate, on deal terms and agreement structure for development and commercial agreements

Regulatory, Clinical, & Quality Guidance

• Provide perspective on U.S. and international regulatory pathways (e.g., 510(k), PMA, De Novo, SaMD frameworks).

• Advise on clinical study design, human factors engineering, post-market surveillance, and evidence generation needs.

• Offer insights on QMS expectations, risk management, manufacturing considerations, and compliance requirements (e.g., ISO 13485).

Client Engagement & Communication

• Participate in client meetings, expert interviews, and workshops as the medical device SME.

• Translate complex engineering or regulatory concepts into clear implications for business and innovation strategy.

• Support development of proposals, thought leadership, and strategic narratives for client deliverables.

• Introduce client, as appropriate, to key people in the CGT network

Qualifications

• Bachelor’s degree in biomedical engineering, mechanical engineering, life sciences, or related field (advanced degree preferred: MS, PhD, MD, or equivalent).

• 7–10+ years of experience in medical device development, R&D, regulatory affairs, quality, clinical affairs, business development or related areas.

• Demonstrated expertise in at least one domain: device engineering, human factors, digital health/SaMD, quality systems, regulatory strategy, or clinical development.

• Prior consulting, advisory, or cross-functional leadership experience is a plus.

• Strong analytical skills and ability to communicate effectively with technical and non-technical stakeholders.

Time Commitment

• Flexible part‑time arrangement (typically 5–20 hours/week depending on project needs).

• Hours can flex based on project stage and consultant availability.

Why Join Wave Strategy?

• Collaborate with a multidisciplinary team shaping innovation across the medical device landscape.

• Highly flexible engagement model - ideal for independent consultants, clinicians, engineers, or industry leaders.

• Opportunities to influence early-stage development, market strategy, and investment decisions.