CA
Senior CMC Product Development Strategy Consultant
Comptech Associates Inc.
🌏 Worldwide
Remote
Senior
1 month ago
- Change Management
- Risk Management
1 month ago
Not enough detail in this posting to match
Location: Primarily Remote (U.S.) with occasional onsite workshops as needed
Duration: 6 Months
No. of Positions: 1
Industry: Biotechnology / Pharmaceutical
Client: Global Clinical-Stage Biopharmaceutical Company
JOB DESCRIPTION
- Our client is seeking a highly experienced CMC Product Development Strategy Consultant to lead the design and development of an enterprise Product Development Roadmap (PDR), a comprehensive governance playbook that standardizes product development activities from pre-clinical development through Phase III and Marketing Application readiness.
- Working closely with senior CMC leadership, the consultant will create a scalable framework that defines development stages, governance, key deliverables, decision points, and cross-functional responsibilities.
- The resulting playbook will become the standard methodology used across all development programs, improving consistency, transparency, execution quality, and organizational readiness.
- This role is ideal for a former pharmaceutical executive or senior consultant with extensive experience leading global CMC development organizations and designing stage-gate governance models.
- Lead the design of a comprehensive Product Development Roadmap (PDR) framework spanning:
- Discovery transition
- Preclinical Development
- IND Readiness
- Phase I
- Phase II
- Phase III
- Marketing Application Readiness
- Commercial Launch Readiness
- Develop an enterprise playbook defining:
- Stage gates
- Governance model
- Key activities
- Required deliverables
- Decision criteria
- Milestones
- Success measures
- Define cross-functional responsibilities across:
- CMC
- Pharmaceutical Development
- Analytical Development
- Manufacturing
- Quality
- Regulatory Affairs
- Clinical Supply
- Technical Operations
- Program Management
- Facilitate workshops with senior leadership to gain alignment on the roadmap structure and governance approach.
- Identify best practices from leading pharmaceutical development organizations.
- Establish standardized templates, governance processes, and repeatable workflows.
- Ensure the roadmap is scalable across multiple development programs and therapeutic assets.
- Support implementation planning and organizational adoption.
- 15+ years of progressive pharmaceutical or biotechnology experience.
- Significant leadership experience within:
- CMC Development
- Pharmaceutical Development
- Technical Operations
- Product Development
- Program Leadership
- Experience supporting products from early development through regulatory submission.
- Demonstrated experience building:
- Stage-gate processes
- Product development frameworks
- Governance models
- Development of playbooks
- Strong understanding of:
- CMC development lifecycle
- IND-enabling activities
- Clinical development
- Regulatory submission requirements
- Commercial readiness
Preferred Qualifications
- Former Director, Senior Director, Executive Director, or Vice President within:
- CMC
- Pharmaceutical Development
- Technical Operations
- Product Development
- Program Management
- Consulting experience with McKinsey, BCG, Bain, Client, PwC, Client, or a specialized life sciences consulting firm is highly desirable.
- Experience developing governance frameworks used across multiple development programs.
- Background supporting biologics, small molecules, gene therapy, or other advanced therapeutic modalities.
Core Competencies
- Pharmaceutical Product Development
- CMC Strategy
- Stage-Gate Governance
- Cross-Functional Leadership
- Executive Facilitation
- Process Design
- Program Management
- Organizational Change Management
- Risk Management
- Regulatory Strategy
- Strategic Planning
- Executive Communications
The consultant will be responsible for developing:
- Enterprise Product Development Roadmap (PDR)
- Product Development Playbook
- Stage-Gate Governance Framework
- Development Lifecycle Framework
- Cross-Functional RACI Matrix
- Key Deliverables Matrix
- Milestone and Decision Framework
- Governance Charter
- Executive Steering Committee Framework
- Standard Templates and Tools
- Executive Presentation Materials
- Implementation & Adoption Roadmap
Success will be measured by the consultant's ability to:
- Develop a standardized, repeatable Product Development Roadmap adopted across all development programs.
- Establish clear governance, stage gates, and decision-making processes.
- Improve cross-functional alignment and accountability throughout the development lifecycle.
- Reduce ambiguity by defining standardized deliverables and milestone expectations.
- Enable consistent planning and execution from preclinical development through marketing application readiness.
- The ideal consultant is a respected pharmaceutical development leader who has successfully guided multiple products through the development lifecycle while building scalable development processes.
- They combine strategic thinking with operational execution and are skilled at facilitating executive alignment across complex, matrixed organizations.
- Their experience allows them to translate industry’s best practices into practical governance frameworks that improve execution, accelerate decision-making, and support long-term portfolio growth.
Senior CMC Product Development Strategy Consultant · Comptech Associates Inc.