Cell & Gene Therapy SME
About the job
- Demonstrated knowledge of the overall drug development process relevant to Cell and Gene Therapy operations.
- Demonstrated knowledge of Good Manufacturing Practices and ISO relevant to Cell and Gene Therapy.
- Advanced proficiency with PowerPoint, Word, Excel, Visio, Project, OneDrive, and SharePoint.
- Proficiency with project management practices, tools, and methodology.
- Ability to analyze and resolve difficult business situations and communicate complex issues simply.
- Ability to organize and manage multiple projects.
- Ability to make effective and persuasive presentations.
- Ability to develop relationships with customers and key stakeholders and manage conflicts.
- Ability to work effectively with local and virtual team members and other professionals.
- Ability to plan, organize, control, and direct projects to maintain client confidence.
- Sound decision-making and judgment.
- Ability to think ahead, take initiative, maintain confidentiality, prepare action plans, meet deadlines, and work in a team environment.
- High attention to detail.
- Ability to organize and perform work independently.
- Excellent written and oral English communication skills.
- Willingness to travel.
- Bachelor of Science or Bachelor of Arts degree in the Life Sciences, or ten years of relevant work experience in lieu of education.
- Ten or more years of multidisciplinary experience in the Cell and Gene Therapy pharmaceutical and biotech industries.
- At least ten years of direct project management experience in Cell and Gene Therapy.
- Experience using project management software to manage complex project timelines and resources.
- Experience supporting sales activities for project services.
- Supervisory experience including employee hiring and retention, oversight, performance review, employee development, and discipline.
- Demonstrate subject-matter expertise in Cell and Gene Therapies through delivery of projects involving product development, analytical method development and transfer, facility startup and qualification, project management, and process improvements.
- Oversee or drive project planning, delivery, communication, and operational or tactical activities.
- Work independently with limited oversight from senior leadership.
- Facilitate project-team meetings, cross-functional communication, and decision-making while ensuring alignment with internal and external stakeholders.
- Oversee and manage project financials.
- Prepare project-team budgets covering resources and costs in collaboration with Finance and other cross-functional departments.
- Evaluate budget compliance and project billings on an ongoing basis.
- Develop project deliverables, including project plans, charters, communication plans, and presentations, and conduct reviews and approvals with client leadership.
- Drive project communications, including status reports and dashboards, to impacted stakeholders.
- Conduct ongoing face-to-face and virtual meetings and workshops.
- Own the quality of work and deliverables under the role’s responsibility.
- Manage project scope and monitor project activity progress.
- Identify risks and issues proactively, collaborate with colleagues and client leads to resolve them, and adjust project plans as needed.
- Own the schedule and quality of assigned projects, when applicable.
- Support the project sales process by developing and reviewing content and participating in sales meetings.
- Support staffing of client projects by identifying and recommending resources, reviewing resumes, and interviewing resources as requested.
- Support development of annual Marketing and Sales plans and materials for Cell and Gene Therapy, including thought leadership content and webinars.
- Track Cell and Gene Therapy industry trends and determine how to leverage them for clients and develop potential service offerings.
- Participate in and present at industry associations and information exchanges related to development of guidance and practice.
- Ensure personnel complete performance-management processes, including goal setting and performance evaluations, in a timely manner.
- Carry out supervisory responsibilities in accordance with organizational policies and applicable guidelines.
- Participate in internal or client-required staff training.
- Enforce Human Resources policies and procedures with support from Human Resources staff.
- Perform other assigned duties.
- An advanced degree in a scientific discipline.
About the company
ProPharma Group provides regulatory sciences consulting and related services for drugs, biologics, medical devices, and diagnostics on a global scale. Its offerings cover the full lifecycle, from early development and clinical trials to regulatory approval and post-market activities. The company’s services include regulatory sciences, clinical research, quality and compliance, pharmacovigilance, medical information, and R&D technology, delivered by a team of over 2,500 professionals with more than 20 years of operation. ProPharma Group differentiates itself by providing expert, end-to-end regulatory and life sciences solutions across multiple product types and stages, helping pharmaceutical, biotechnology, and medical device companies navigate complex regulatory and compliance challenges. The goal is to help clients bring safe and compliant products to market efficiently while maintaining ongoing lifecycle support.
Company Size
1,001-5,000
Company Stage
N/A
Total Funding
N/A
Headquarters
Raleigh, North Carolina
Founded
2001
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Simplify's Take
What believers are saying
- Adrian Pencak became chief commercial officer on May 27 2026, sharpening global sales execution.
- Hyderabad opened December 11 2025, adding capacity for more teams and delivery scale.
- ProPharma will exhibit at World Patient Safety Congress Europe 2026 on September 23.
What critics are saying
- ProPharma sued former SVP Anthony Crone on June 3 2026 over trade secrets.
- Revelio Labs shows headcount fell to 2,301 in March 2026, down from 2,369.
- Odyssey ownership pressures margins if AI commoditizes regulatory services, shrinking ProPharma's advisory moat.
What makes ProPharma Group unique
- ProPharma spans regulatory, clinical, quality, pharmacovigilance, and medical-information services end-to-end.
- July 8 2026 AI-assisted ANDA drafting embeds proprietary automation inside expert-led delivery.
- January 27 2026 SBTi-approved net-zero targets strengthen its enterprise operating model.
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6 month growth
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24%Welcome Laurie Rouse and Todd Sevier to the Compli team. August 5, 2026 Compli is excited to welcome two new hires into its leadership team, even furthering its team's strength and operational success. Laurie Rouse joins its team as Operations Manager and Todd Sevier as Principal - (Commissioning, Qualification and Validation services (CQV). "I am excited to welcome Todd and Laurie to the Compli team," said Compli President Greg Spanel. "Each brings a unique and valuable set of skills that will help drive Compli's vision for the future. Their addition strengthens our ability to better serve both our employees and our clients, while supporting our continued growth and success." Laurie Rouse - Operations Manager. Laurie has extensive experience in operations management, process improvement and administrative leadership, recently serving as Senior Manager of Global Audit Coordination at ProPharma Group. In this role, she oversaw the day-to-day operations of the global audit department and partnered with cross-functional teams to develop and implement departmental processes and policies. "This is an exciting opportunity to join Compli at a time of continued growth. I look forward to contributing to operational improvements, supporting our talented team and helping the organization achieve its strategic objectives." said Rouse. In her new role, Laurie will help drive operational excellence, supporting strategic initiatives and positioning Compli for continued growth. Compli is excited to welcome Laurie to the team and look forward to the contributions she will make in the years ahead. Todd Sevier - Principal - CQV. Todd joined Compli most recently with ProPharma Group, where he served as Director of Compliance and Quality Assurance, bringing extensive experience in quality systems, regulatory compliance, validation, and project leadership within highly regulated industries. In his new role, Todd will lead Compli's CQV service group, providing strategic direction, technical expertise and mentorship to team members while supporting clients through CQV initiatives. His leadership will help strengthen Compli's commitment to delivering flexible, high-quality CQV solutions that support projects of all sizes and complexities. "I'm excited to join a team that is recognized for its technical expertise and client-focused approach," said Todd. "I look forward to working alongside the talented professionals at Compli, supporting our clients' success and helping grow the next generation of CQV leaders."
ProPharma, a global provider of regulatory, clinical, and compliance services for life sciences, has launched a proprietary AI-assisted capability to enhance Abbreviated New Drug Application submission development. The technology, part of ProPharma's Technology Enablement Strategy, aggregates and analyses information from multiple data sources to generate structured first drafts, reducing manual authoring effort. The AI tool enables ProPharma's regulatory experts to focus on scientific evaluation, strategic guidance, and quality review. According to Matthew Weinberg, president of regulatory sciences, the capability aims to reduce authoring timelines whilst maintaining scientific rigour. Chief executive Dawn Sherman emphasised that the technology enhances rather than replaces expertise. ProPharma is integrating purpose-built technologies across its service areas, including regulatory affairs, clinical research, and pharmacovigilance. The company is a portfolio company of Odyssey Investment Partners.
ProPharma advances Technology Enablement Strategy with ai-assisted capability for ANDA submission development. ProPharma's new proprietary tool accelerates regulatory submissions while ensuring top-tier quality and compliance for global pharmaceutical clients. July 8, 2026 Press Contacts Shannon Severino 412-608-2393 RALEIGH, N.C. - ProPharma, the leading global provider of regulatory, clinical, and compliance services for the life sciences industry and a portfolio company of Odyssey Investment Partners, today announced another milestone in its Technology Enablement Strategy with the deployment of a proprietary AI-assisted capability that enhances how the company develops Abbreviated New Drug Application (ANDA) submissions for clients. The AI-assisted capability was purpose-built to support ProPharma's regulatory teams and their clients in the development of ANDA submissions. By intelligently aggregating and analyzing information from multiple data sources and document formats, the technology generates structured first drafts that significantly reduce manual authoring effort. This enables ProPharma's regulatory experts to dedicate more time to scientific evaluation, strategic regulatory guidance, quality review, and client collaboration. "The future of regulatory submissions is not about replacing experts with technology," said Matthew Weinberg, President, Regulatory Sciences at ProPharma. "It's about empowering experts with better tools. By combining human expertise with AI-enabled efficiencies, we are helping clients reduce authoring timelines, improve operational effectiveness, and maintain the scientific rigor and regulatory excellence that have always been central to ProPharma's approach in a more cost-effective way." Developed specifically to enhance ProPharma's internal regulatory delivery process, the capability is designed to improve consistency, completeness, and traceability throughout submission development while supporting the rigorous quality and compliance standards expected by global health authorities. It also enables more efficient management of regulatory questions and deficiency responses throughout the submission lifecycle. For clients, these enhancements translate into meaningful benefits, including: * Accelerated ANDA preparation and submission timelines * Reduced manual document authoring effort * Improved consistency and completeness across submission content * Enhanced traceability throughout submission development * More efficient management of regulatory questions and deficiency responses * Better utilization of regulatory resources while maintaining high-quality submissions "Technology should enhance expertise, not replace it," said Dawn Sherman, Chief Executive Officer of ProPharma. "Our Technology Enablement Strategy reflects our commitment to continuously improving how we serve clients by equipping our experts with innovative capabilities that increase efficiency, strengthen quality, and accelerate delivery. This AI-assisted capability is one example of how we're investing in the future of expert-led life sciences services." Technology Enablement is ProPharma's enterprise-wide strategy for integrating proprietary technology, intelligent automation, and artificial intelligence into the way its experts deliver services across the organization. ProPharma is embedding purpose-built technologies into its expert-led delivery model across regulatory affairs, clinical research, pharmacovigilance, quality and compliance, medical information, and consulting services. The initiative is designed to improve efficiency, consistency, scalability, and client outcomes while preserving the scientific expertise, regulatory judgment, and human oversight that remain at the core of every engagement. For more than 25 years, ProPharma has improved patients' health and wellness by providing expert guidance that empowers biotech, pharmaceutical, and medical device organizations to confidently advance scientific breakthroughs and bring new therapies to market. With deep expertise in regulatory sciences, CRO services, quality and compliance, pharmacovigilance, medical information, FSP solutions, and digital transformation, ProPharma delivers integrated, end-to-end solutions that help organizations navigate complexity, mitigate risk, and accelerate the development and commercialization of life-changing therapies. For more information about ProPharma, please visit propharmagroup.com. Odyssey Investment Partners Odyssey Investment Partners is a leading private equity investment firm with more than a 25-year history of partnering with skilled managers to transform middle-market companies into more efficient and diversified businesses with strong growth profiles. Odyssey makes majority-controlled investments in industries with a long-term positive outlook and favorable secular trends. For further information about Odyssey, please visit odysseyinvestment.com.
ProPharma appoints Adrian Pencak as Chief Commercial Officer. May 27, 2026, 09:42 AM by Life Sciences Industry Veteran Appointed to Lead Global Commercial Organization RALEIGH, N.C. - May 27, 2026 - ProPharma, a leading provider of regulatory, clinical, and compliance services for the life sciences industry, today announced the appointment of Adrian Pencak as Chief Commercial Officer. He will be responsible for leading ProPharma's global commercial organization, across its full suite of regulatory, clinical, and compliance services. Pencak brings more than 25 years of executive commercial leadership experience across pharma services, clinical development, technology-enabled solutions, and global Contract Research Organizations. Throughout hiscareer, he has built and led high-performing commercial teams, driven significant global revenue growth, and developed scalable go-to-market strategies for many of the life sciences industry's leading organizations. Prior to joining ProPharma, he held senior commercial leadership positions at organizations including IQVIA, Advarra, PharmaLex, and ICON plc, where he focused on expanding strategic accounts, strengthening global partnerships, and advancing commercial growth across international markets. His experience spans both full-service outsourcing and Functional Service Provider (FSP) models, with a strong track record of supporting leading pharmaceutical, biotechnology, and life sciences organizations through complex development and commercialization initiatives. "Adrian brings deep commercial leadership experience across the life sciences services landscape and understands the importance of delivering integrated solutions that help clients navigate increasingly complex development and commercialization challenges," said Dawn Sherman, Chief Executive Officer of ProPharma. "His experience scaling global commercial organizations and building strong client partnerships will be an important asset as we continue expanding our global capabilities and supporting clients across the full product development lifecycle." "ProPharma has built an outstanding reputation for helping clients navigate complex regulatory, clinical, and compliance challenges across the product lifecycle to help bring therapies to patients faster," said Adrian Pencak. "I'm excited to join the organization at this stage of growth and look forward to partnering with teams across the business to strengthen strategic client relationships, scale commercial capabilities, and continue delivering high-value solutions that help accelerate innovation across the life sciences industry." Pencak is also active in the broader life sciences community as a speaker and contributor at industry events, including Bio-IT World and the European Clinical Data Forum. His work has included thought leadership on the use of technology and artificial intelligence in clinical and regulatory environments, as well as the modernization of pharma services operating models. About ProPharma For more than 25 years, ProPharma has improved patients' health and wellness by providing expert guidance that empowers biotech, pharmaceutical, and medical device organizations to confidently advance scientific breakthroughs and bring new therapies to market. With deep expertise in regulatory sciences, CRO services, quality and compliance, pharmacovigilance, medical information, FSP solutions, and digital transformation, ProPharma delivers integrated, end-to-end solutions that help organizations navigate complexity, mitigate risk, and accelerate the development and commercialization of life-changing therapies. For more information about ProPharma, please visit propharmagroup.com. About Odyssey Investment Partners Odyssey Investment Partners is a leading private equity investment firm with more than a 25-year history of partnering with skilled managers to transform middle-market companies into more efficient and diversified businesses with strong growth profiles. Odyssey makes majority-controlled investments in industries with a long-term positive outlook and favorable secular trends. For further information about Odyssey, please visit odysseyinvestment.com.
ProPharma, a provider of regulatory, clinical and compliance services for the life sciences industry, has appointed Adrian Pencak as Chief Commercial Officer. He will lead the company's global commercial organisation across its full service portfolio. Pencak brings over 25 years of executive commercial leadership experience in pharma services, clinical development and contract research organisations. He has previously held senior commercial positions at IQVIA, Advarra, PharmaLex and ICON plc, focusing on strategic accounts and global partnerships. In his new role, Pencak will strengthen client relationships, scale commercial capabilities and deliver solutions to accelerate innovation across the life sciences industry. He is also active in the broader life sciences community, speaking at industry events on technology and artificial intelligence in clinical environments.