Advanced Cross-Functional Team Leadership in Pharma R&D Training Course

Advanced Cross-Functional Team Leadership in Pharma R&D Training Course

Introduction

In today's complex biopharma landscape, characterized by accelerated innovation cycles, escalating R&D costs, and the imperative for novel mechanisms of action, the traditional siloed approach to drug development is obsolete. Success hinges on a leaderΓÇÖs ability to orchestrate high-performing, Agile cross-functional teams (CFTs). This requires moving beyond basic collaboration to mastering matrix navigation, strategic alignment, and leveraging digital dexterity. Our industry leaders are now tasked with unifying experts from Clinical Operations, Data Science, Medical Affairs, and Regulatory to drive a patient-centric vision, transforming scattered insights into data-driven decision-making that accelerates pipeline progression and secures competitive advantage against the looming patent cliff. 

Advanced Cross-Functional Team Leadership in Pharma R&D Training Course is specifically designed to equip current and emerging leaders with the sophisticated soft-power leadership and integrated project management skills essential for the next generation of drug development. Participants will learn to foster a culture of psychological safety and radical transparency, enabling diverse teams to navigate conflicting priorities and regulatory complexity effectively. By focusing on ecosystem orchestration, real-world evidence (RWE) integration, and AI-powered drug development platforms, this course provides the strategic blueprint for breaking down organizational silos, accelerating the delivery of breakthrough therapies, and ultimately, increasing the Internal Rate of Return (IRR) of their organization's R&D portfolio.

Course Duration

10 days

Course Objectives

1. Develop and champion a shared, patient-centric R&D vision that unifies priorities across Discovery, Clinical, Regulatory, and Commercial.
2. Leverage AI-powered drug discovery and digital biomarkers to enhance R&D processes and inform project strategy.
3. Implement soft-power leadership techniques to manage authority and influence effectively in a highly matrixed global organization.
4. Design an omnichannel communication framework for senior management review meetings and external partners
5. Employ advanced negotiation and de-escalation strategies to resolve conflicting functional priorities in high-stakes projects.
6. Establish psychological safety and radical transparency as the foundational operating model for high-performing CFTs.
7. Implement systems for transparent knowledge transfer and real-time insight sharing across all project disciplines.
8. Apply Agile methodologies and sprint planning to accelerate key drug development milestones and decision gates.
9. Strategically incorporate RWE and digital health solutions into clinical trial design and post-market planning.
10. Lead diverse, global teams by bridging not just functional but also cultural divides in communication and decision-making styles.
11. Define and track cross-functional KPIs to measure true team efficacy.
12. Implement effective delegation models that promote shared ownership and develop Emerging R&D Leaders.
13. Integrate robust data governance and bioethics principles into all AI/digital R&D initiatives.

Target Audience

1. Program/Project Managers
2. Functional Directors/Associate Directors
3. Medical Affairs/Commercial Leads
4. Clinical Development Leads (MD/PhD).
5. Regulatory Affairs/Quality Assurance Managers.
6. Data Science/Informatics Leaders.
7. Emerging R&D Leaders.
8. Alliance/Partnering Managers

Course Modules

Module 1: The Strategic Imperative of Cross-Functional R&D

• The business case for CFTs.
• Analyzing the competitive threat of the Patent Cliff and the need for speed.
• The evolution of the Pharma R&D operating model 
• Defining the core challenge.
• Mapping key R&D milestones to cross-functional interdependencies.
• Case Study: The Pfizer/BioNTech Vaccine DevelopmentΓÇöExtreme Cross-Functional Speed and Scale.

Module 2: Advanced Matrix Navigation & Soft-Power Leadership

• Mastering soft-power influence when formal authority is absent.
• Techniques for managing dual-reporting lines and functional loyalty.
• Negotiating resource allocation across competing portfolio priorities.
• Applying the "Investor's View" to stage-gate decisions and portfolio value.
• Strategies for building credibility with senior stakeholders and functional heads.
• Case Study: Navigating a Global M&A Integration: Aligning two distinct R&D cultures and IT/Data systems.

Module 3: Strategic Alignment and Patient-Centric Vision

• Developing a shared, measurable, patient-centric purpose for the R&D team.
• Translating the Target Product Profile (TPP) into cross-functional objectives.
• Aligning technical metrics with the commercial value story.
• Using a Global Value Dossier (GVD) mindset from Discovery forward.
• Establishing common cross-functional KPIs
• Case Study: Lilly's Early Obesity/Diabetes Drug DevelopmentΓÇöIntegrating Clinical Efficacy with Market Access Strategy from Phase I.

Module 4: Cultivating Psychological Safety and Trust

• The science of Psychological Safety and its direct link to innovation and error reporting.
• Implementing Radical Transparency in data sharing and roadblock communication.
• Techniques for running effective, non-judgmental After-Action Reviews.
• Managing the risk of groupthink and encouraging constructive dissent.
• Building a culture of mutual respect between scientists, clinicians, and business professionals.
• Case Study: A Major Pharma CompanyΓÇÖs Data Integrity CrisisΓÇöRebuilding Trust and Reporting Culture after a Protocol Deviation.

Module 5: Conflict Resolution in High-Stakes Environments

• Identifying the root causes of conflicting priorities.
• Applying a structured, neutral process for high-impact conflict resolution.
• Techniques for separating functional differences from personal conflicts.
• Advanced negotiation skills for securing commitments from resource-constrained teams.
• Addressing resistance to change and functional protectionism head-on.
• Case Study: Resolving the Phase II Pivot: Clinical urgency conflicts with Manufacturing scale-up limitations.

Module 6: Accelerating R&D with Agile Methodologies

• Introduction to Agile R&D principles adapted for long drug development cycles.
• Implementing bi-weekly Sprints for rapid evidence generation and decision-making.
• Running effective daily stand-ups and retrospectives for cross-functional teams.
• The role of the CFT Leader as a Scrum Master and impediment remover.
• Using visual management for transparent workflow.
• Case Study: Integrating Real-Time Data Monitoring into a Decentralized Clinical Trial (DCT) using Agile Sprints.

Module 7: Leveraging Digital Dexterity and AI

• Understanding the application of AI in Drug Discovery and target identification.
• Leading teams that integrate data science and bench science expertise.
• Identifying and leveraging Digital Biomarkers in clinical trial endpoints.
• Overcoming barriers to data democratization and unified IT infrastructure.
• Ethical and regulatory considerations for AI in R&D
• Case Study: A BiotechΓÇÖs Successful use of Machine Learning to de-risk a portfolio of Novel MoAs in a rare disease area.

Module 8: Driving Real-World Evidence (RWE) Strategy

• The strategic value of incorporating RWE from discovery through commercialization.
• Collaborating with HEOR and Market Access teams to define value endpoints.
• Leading the transition from randomized controlled trials (RCTs) to hybrid/decentralized models.
• Ensuring Data Governance and privacy compliance in RWE collection.
• Using RWE to inform and adjust existing clinical protocols mid-trial.
• Case Study: BMS's RWE strategy for a new oncology assetΓÇöusing registry data to expand the label post-approval.

Module 9: Ecosystem Orchestration and External Alliances

• Strategies for effective leadership of external partnerships
• Defining clear governance models and intellectual property (IP) agreements with partners.
• Managing cultural differences and communication with non-pharma collaborators
• Building a Virtual R&D Team that spans multiple organizations and geographies.
• Metrics for evaluating the performance and value delivery of external alliances.
• Case Study: Managing the Collaborative RiskΓÇöA Pharma-Biotech Alliance failure and the lessons learned in governance.

Module 10: Advanced Stakeholder Communication

• Developing an Executive-Ready Communication strategy for R&D updates.
• Techniques for creating an effective presentation for Senior Management Review Meetings.
• Translating complex scientific findings into clear business insights.
• Designing an omnichannel plan for internal and external progress transparency.
• Anticipating and proactively addressing stakeholder concerns and questions.
• Case Study: Presenting a High-Risk, High-Reward Portfolio Pivot to the CEO and Board R&D Committee.

Module 11: Cross-Cultural Intelligence (CQ) in Global R&D

• Understanding how national and functional cultures influence decision-making and risk-taking.
• Strategies for leading geographically dispersed teams effectively.
• Addressing differences in communication styles.
• Managing the complexities of global regulatory harmonization and local trial requirements.
• Fostering an inclusive environment where all perspectives are valued and heard.
• Case Study: Leading a joint US-China-EU Clinical OperationΓÇöBridging Time Zones, Regulation, and Hierarchy.

Module 12: Leadership in Crisis & Change Management

• Leading a CFT through a major R&D crisis
• Applying the principles of Change Management to major organizational restructuring or process overhauls.
• Communicating difficult news with empathy and transparency.
• Maintaining team focus and morale during periods of high volatility, uncertainty, complexity, and ambiguity
• Developing a contingency planning and risk mitigation framework for R&D projects.
• Case Study: A Pharma CompanyΓÇÖs Response to a Surprise FDA Clinical Hold Managing Internal and External Communications Under Pressure.

Module 13: Measuring and Rewarding Collaborative Performance

• Defining team success metrics beyond simple timeline/budget adherence.
• Implementing cross-functional 360-feedback mechanisms for team members.
• Designing incentive structures that reward collaboration over functional silo achievement.
• Conducting effective after-action reviews to foster continuous learning.
• Developing a coaching and mentorship framework for emerging R&D leaders.
• Case Study: The Novartis/Genentech Model Implementing Shared Incentive Compensation for Multi-Site, Multi-Functional Teams.

Module 14: Financial Acumen for R&D Leaders

• Understanding and communicating the drivers of R&D cost per asset.
• Applying Activity-Based Costing (ABC) to R&D projects for better resource allocation.
• Interpreting and leveraging the Internal Rate of Return (IRR) for portfolio optimization.
• Making go/no-go decisions based on integrated clinical, regulatory, and market data.
• Budgeting and forecasting for Agile R&D projects.
• Case Study: Using Financial Simulation to Optimize a Discovery Program's Spending on Novel MoAs vs. Fast-Follower Assets.

Module 15: Personal Leadership Roadmap and Action Planning

• Self-assessment of current Matrix Leadership strengths and gaps.
• Developing a personal Cross-Functional Leadership Action Plan
• Techniques for delegating strategically to build Emerging Leader capabilities.
• Building a powerful professional network across functional and geographic boundaries.
• Commitment to continuous learning in R&D Innovation and leadership best practices.
• Case Study: Developing an IndividualΓÇÖs Leadership Brand: Moving from Technical Expert to Strategic Cross-Functional Leader.

Training Methodology

This course employs a high-impact, experiential learning methodology designed for senior R&D professionals:

• Case Study Immersion
• Role-Playing Simulations.
• Peer Consulting & Workshops
• Leadership Diagnostics.
• Expert Sessions.

Register as a group from 3 participants for a Discount

Send us an email: info@datastatresearch.org or call +254724527104 

Certification

Upon successful completion of this training, participants will be issued with a globally- recognized certificate.

Tailor-Made Course

 We also offer tailor-made courses based on your needs.

Key Notes

a. The participant must be conversant with English.

b. Upon completion of training the participant will be issued with an Authorized Training Certificate

c. Course duration is flexible and the contents can be modified to fit any number of days.

d. The course fee includes facilitation training materials, 2 coffee breaks, buffet lunch and A Certificate upon successful completion of Training.

e. One-year post-training support Consultation and Coaching provided after the course.

f. Payment should be done at least a week before commence of the training, to DATASTAT CONSULTANCY LTD account, as indicated in the invoice so as to enable us prepare better for you.