Associate Principal / Principal Consultant

ProductLife Group is a global consulting and outsourcing partner to the life sciences industry. We support pharmaceutical and biotechnology companies across the full product lifecycle, from early development through post-marketing activities.

We are seeking an Associate Principal/Principal Consultant for clinical development and clinical operations.

• Serves as a senior clinical development and clinical operations advisor for biotechnology and pharmaceutical clients, providing program-level leadership across early and late stages of development.
• Develops and defends integrated clinical development strategies that balance safety, feasibility, innovation, regulatory expectations, and client risk tolerance.
• Leads cross-functional clinical teams spanning Clinical Development, Clinical Operations, Regulatory, Quality, Medical Safety, and Translational functions.
• Provides clinical leadership on behalf of clients, including interim or advisory clinical leadership roles and mentoring of client teams to drive performance and organizational efficiency.
• Designs, evaluates, and optimizes clinical trial strategies, including alternative and innovative study designs to improve cost, timeline, and feasibility.
• Oversees and contributes to development of key clinical documents, including clinical development plans, protocol synopses, protocols, informed consent forms, clinical study reports, and clinical sections of regulatory submissions.
• Leads Scientific Advisory Committee planning and execution, including defining strategic objectives, target profiles, key questions, and interpreting outcomes to inform development decisions.
• Conducts and supervises competitive landscape analyses, literature reviews, and diligence activities to identify gaps, risks, and opportunities across development programs.
• Provides strategic oversight of clinical operations activities, including CRO and vendor selection, vendor oversight, risk-based monitoring strategies, and operational execution plans.
• Leads gap analyses and process optimization initiatives to strengthen client clinical organizations, governance structures, and ways of working.
• Acts as project lead for complex, multi-disciplinary clinical programs by establishing project plans, budgets, timelines, and resource models.
• Monitors, analyzes, and reports program and project status; proactively identifies and mitigates clinical, operational, and execution risks.
• Develops and delivers clear, audience-appropriate messaging for senior client stakeholders, including executive leadership and boards.
• Supports business development activities through early input into scope definition, proposal development, and statements of work.
  Educates current and prospective clients on clinical development and operations services to support long-term partnerships.
• Participates in internal initiatives including invoicing, bookings, development of new service offerings, publications, workshops, conferences, and process optimization activities.
• Mentors and develops internal team members across the organization, providing clinical subject-matter leadership through direct, project-based, or matrixed relationships.

• Bachelor’s degree in a scientific or health‑related discipline.
• Minimum of 15+ years of progressive experience in Clinical Development and/or Clinical Operations within a biotechnology or pharmaceutical environment.
• Proven experience leading clinical development strategy and clinical programs across multiple stages of development.
• Demonstrated ability to provide senior clinical leadership in cross‑functional and matrixed organizations.
• Experience overseeing multiple clinical trials and programs concurrently in a sponsor and/or consulting setting.

• Clinical development strategy design and execution across early and late-stage programs.
• Clinical operations leadership, including trial execution oversight, CRO/vendor selection, vendor management, and risk-based operational strategies.
• Protocol and clinical document development, including oversight and authoring of core clinical sections of regulatory submissions.
• Strong understanding of global regulatory guidance, GxPs, and industry standards applicable to clinical development and operations.
• Scientific and clinical interpretation of competitive data, literature, and emerging industry trends.
• Program-level risk identification, assessment, and mitigation across clinical development and execution.
• Project leadership, budgeting, resourcing, and timeline management for complex, multi-disciplinary programs.
• Stakeholder communication and executive-level presentation skills.