Clinical Development Strategies: Beyond Clinical Trials

  • Executive Education
Two clinician scientists sit at a computer looking at data.
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Registration Deadline: September 4

Learn to improve clinical trial design and performance, and think beyond trial outcomes to facilitate the success of products throughout their development lifecycles.

  • Online; Self-Paced

Self-paced learning complemented by live sessions with faculty and weekly office hours conducted by program leaders.

$5,950

Flexible payment and team-based learning options are available. 

Certificate

Upon completion of this program, you will receive a digital certificate from Harvard Medical School.

14 Weeks, 3-5 Hours/Week

Each week you will engage with recorded video lectures from faculty, attend webinars and office hours, complete quizzes and required activities, engage in moderated discussion groups with, and work on your final project, if required.

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Overview

Clinical Development Strategies: Beyond Clinical Trials will equip you to use the right tools and technologies to unlock increased value in clinical development projects and help facilitate the success of products throughout their development life cycles. This 14-week online program offers the opportunity to elevate your career and think beyond clinical trial outcomes with insights from Harvard Medical School faculty and leading practitioners at the cutting edge of the pharmaceutical and biotech industries. The asynchronous curriculum features a mix of online sessions, relevant case studies and industry examples, product development frameworks, digital tools and peer discussions for a stimulating learning experience.

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Participant Types

Leaders of clinical trials; Experienced technical professionals in clinical trial functions

Curriculum

The program’s curriculum spans 13 modules covering trends and industry factors that are shaping clinical development today. The overarching topics include global changes in novel therapeutic modalities, the rare disease landscape and patient advocacy, adoption of digital technology and the importance of improving access and equity in clinical trials. These topics are explored in-depth, providing you with the knowledge and skills to optimize clinical trials strategies and maximize your impact as an innovative clinical development leader.

At the end of select modules, you will get an opportunity to complete a self-study Leadership Lens activity. Here you will apply what you have learned throughout the program to your organization and experiences. The goal is to create a valuable reference point for your future leadership roles.

The program includes a capstone project which is an integral part of the learning journey. A series of reflective exercises across three critical stages of the program is designed to strategically consolidate and deepen your leadership skills within the context of clinical development and practice. Each checkpoint will address key aspects of leadership in clinical development, from personal mindset to skill advancement and strategic application, to foster a deeper understanding of how effective leadership can influence and drive success in clinical research and development. This comprehensive component combines theory with the practical realities of leadership in life sciences, addressing your organization's challenges.

This Harvard Medical School Executive Education program is taught by HMS faculty and is promoted by Emeritus. Emeritus is responsible for advertising, marketing, registration, and collecting payment.

Questions?

Contact one of our program advisors at learner.success@emeritus.org.

Learning Modules

Learn to identify recent global changes in therapeutic modalities, the rare diseases landscape and patient advocacy roles that capture value in approved therapies within the life sciences industry.

Assess opportunities and risks in digital medicine, recognize the scope of success for therapeutic modalities and the role of access and equity, and strategize for equitable access in clinical trial designs.

Trace the origins of patient centricity, distinguish between reactive and proactive patient involvement and articulate how patient input informs decisions throughout the development life cycle. 

Understand the evolving landscape of clinical trials, identify knowledge dissemination among role groups in the trials life cycle and leverage clinical design to optimize development timelines and recruitment.

Explore opportunities for integrating digital technologies in clinical trial functions, outline the process of developing these technologies, identify their revenue potential and leverage your digital technology knowledge as a leader to make strategic decisions for your organization. 

Explore how to best leverage digital technologies in clinical development and throughout the value chain.

Examine the application of real-world data in the pharmaceutical life cycle, summarize regulatory guidance, explore advanced real-world evidence analysis methods and assess the deployment of a real-world evidence strategy.

Explore fundamental concepts and AI approaches across the pharmaceutical life cycle.

Explore emerging concepts surrounding the value that novel therapies can offer to patients, caregivers and society with a focus on evidence and insights before and after market launch. 

Explore key concepts of the product development framework, beginning with patient needs and working backward, to facilitate decision making on topics such as team structure, resources and clinical trial operations.

Understand how clinical development, medical affairs and commercial functions can work together to address the challenges of regulatory approvals and timeliness.

Understand key concepts that enhance your leadership effectiveness and management skills within your organizational context. Conclude your learning experience with a capstone project that provides insightful reflections on preceding modules.

Teaching Team

Stanley Shaw.

Stanley Shaw

MD, PhD

  • Executive Education Teaching Associate, Harvard Medical School
Justin Gainor.

Justin Gainor

MD

  • Assistant Professor of Medicine, Harvard Medical School
  • Director, Center for Thoracic Cancers, Massachusetts General Hospital
  • Director, Targeted Immunotherapy, Henri and Belinda Termeer Center for Targeted Therapies
Shamiram Feinglass.

Shamiram Feinglass

MD, MPH

  • Life Sciences & Device Executive, Fellow at The Aspen Institute
Andrew Beam.

Andrew Beam

PhD

  • Chief Technology Officer, Lila Sciences, Inc.
  • Associate Professor of Epidemiology, Harvard T.H. Chan School of Public Health
Anupam Jena.

Anupam Jena

MD, PhD

  • Joseph P. Newhouse Professor of Health Care Policy at Harvard Medical School
  • Associate Professor of Medicine and Associate Physician in the Department of Medicine at Massachusetts General Hospital

From Our Learners

Hear from HMX students as they share their experiences learning online with Harvard Medical School.

View All Learner Stories

Pietro Vercesi Headshot.

Pietro Vercesi

"During the courses, you are exposed to an umbrella of topics that convey a much bigger learning experience, ensuring key elements are covered and well understood."

Interview with HMX Participant Pietro Vercesi

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