Clinical Development Strategies: Beyond Clinical Trials

Inquiring For
Total Work Experience

Harness Today's Clinical Development Challenges for Tomorrow's Breakthroughs

Disruptive changes in the pharmaceutical industry landscape are opening up new approaches to optimize clinical trial strategy. This includes patient-centric study design and digital technologies to enhance clinical research, trial efficiency and revenue generation. Opportunity also exists for data science to revolutionize drug development and clinical trials, with insights from real-world data informing trial strategies, protocol design and exclusion criteria; however, rapid innovation has increased the complexity of trials and costly delays are common, placing unsustainable pressure on trial sites. Clinical development leaders must understand how technological advances like artificial intelligence can improve drug development, while finding solutions to diversity and equity in trials.

The 14-week Clinical Development Strategies: Beyond Clinical Trials program from Harvard Medical School Executive Education will equip you to address these challenges and unlock increased value in clinical development projects. Using the latest digital tools, frameworks and case studies taught by Harvard Medical School faculty and leading practitioners, you will learn to improve clinical trial design and performance as well as think beyond trial outcomes to facilitate the success of products throughout their development lifecycles.

You will also explore AI's impact on clinical workflows and health care transformation. This includes examining its strategic implications and addressing AI adoption considerations, including feasibility, integration challenges and stakeholder engagement, considering both short-and long-term organizational needs.

Note: This program does not grant academic credit or professional certifications from Harvard Medical School.


80%

of clinical trials fail to meet the initial patient enrollment target and timeline, resulting in up to US$8 million per day in lost revenue for drug developing companies.
SOURCE: NATIONAL LIBRARY OF MEDICINE

56%

of clinical trial sites say trials are more complex now than three years ago.
SOURCE: BAIN & COMPANY

Key Takeaways

  • Identify key drivers of change in the life sciences industry

  • Explain how traditional clinical trials practices are evolving to address the demands of the life sciences industry

  • Understand how digital solutions and real-world evidence can add value across the clinical development life cycle

  • Leverage the strategies and emerging technologies needed to accelerate results when leading clinical development projects

  • Apply frameworks and innovative approaches to guide key decision making during clinical research

Who Is This Program For?

The Clinical Development Strategies: Beyond Clinical Trials program is designed for:

  • Leaders of clinical trials looking to stay informed about and embrace industry changes to drive tangible value for clinical development organizations

  • Experienced technical professionals in clinical trial functions seeking to broaden their understanding of the clinical development process and pharmaceutical industry trends to grow in their careers

Why Harvard Medical School

Harvard Medical School Executive Education provides emerging and established companies with the knowledge they need to address the industry's toughest business challenges. Our extensive portfolio of learning solutions helps teams achieve their potential by advancing their knowledge and capabilities in areas ranging from medical science and emerging diseases to employee health and wellness. A comprehensive ecosystem of online, in-person and hybrid solutions support learners at all levels—from new hires to CEOs and their leadership teams.

Learning Experience

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Comprehensive Curriculum

Benefit from a powerful curriculum that combines evidence-based frameworks with an application-based approach

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Self-Paced Learning

Learn at your own pace with a weekly commitment of three to five hours

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Expert Faculty

Glean insights from leading subject matter experts with deep life sciences industry experience and expertise in Gen AI, data, patient centricity, trials design, and other significant domains

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Live Sessions

Live sessions with faculty and weekly office hours conducted by program leaders

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Capstone Project

Work on a capstone project with a series of reflective exercises combining theory with leadership realities in the life sciences industry to address your organization's challenges for immediate impact at work

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Case Studies

Access case studies and industry examples from the pharmaceutical and biotechnology sectors

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Frameworks and Tools

Apply useful frameworks and innovative approaches to incorporate digital tools and guide key decision-making in clinical trial functions

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Hands-On Learning

Work on Leadership Lens activities across modules, with general feedback provided by the grading team and periodic knowledge checks and self-study activities

Curriculum

*Note - Modules are subject to change

Capstone Project

The capstone project is an integral part of your learning journey, a series of reflective exercises across three critical stages of the program. It 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.

Past participants profile

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Testimonials

"The faculty members delivered highly engaging content, bringing years of experience and deep knowledge to the course. This made the course not only informative but also captivating, which is crucial ...
Keyur Trivedi
HMX Participant
"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."
Pietro Vercesi
HMX Particpant
"The best part of this program for me is that it provided me with an understanding of the industrial landscape, biopharma and biotech in particular. The discussions about leadership were also extremel...
Miyuki Sakuma
Scientist,
Boston Children's Hospital
"I want to express my deep gratitude for this clinical development program. The lectures and activities were outstanding, detailed and incredibly beneficial — especially the sessions on growth mindset...
Luis Laguna Perez,
Feasibility Specialist, ICON Global Strategic Solutions providing Services to Vertex Pharmaceuticals
"There were many interesting and captivating modules in this program, including digital trends impacting biopharma, digital tools and therapeutics and artificial intelligence in the life science indus...
Anne Mativo
Database Clinical Programmer/Developer, BMS
"This program provided a comprehensive view of how clinical strategy is evolving, especially with the integration of real-world evidence, digital transformation and market-access strategies. The progr...
Lei Wang
Director CAR-T-Cell Therapy Development, MiGenTra GmbH
"Enrolling in this program was perfectly timed for me as I was planning a career move from a medical affairs program manager role to a clinical trial design lead role in the clinical design and develo...
Deepti Thete
Associate Director- Portfolio and Project Management, Eli Lilly
"The real-world applications in all modules were very valuable. Having leading experts in the fields present case studies and share summaries of their experience made the course feel more current and ...
Michael Lama
Field Clinical Specialist, Inspire Medical Systems
"Engagement on self-study discussion boards, Ayman’s sessions and active round table discussions enabled collaboration in the cohort, as many students came from various roles."
Reena Tut-Parhar
Sr. Clinical Research Coordinator/Manager,
Dr. LORNE Albrecht
"I enjoy the leadership development of the program, which was the best part of the program for me. I wish the program were more in-depth, but overall it was excellent. I learnt a significant amount, t...
Delia Constanza Guaqueta
Medical Oncologist, Memorial Regional Hospital
"This enriching experience has provided me with a holistic view of the far-reaching impact of clinical development strategies. It had equipped me with cutting-edge tools/frameworks to map the crucial ...
Sara Chan
Clinical Operations Lead, Roche

Program Faculty

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Stanley Shaw, MD, PhD

Faculty Co-Director; Associate VP, Global Medical, Amgen; Executive Education Teaching Associate, Harvard Medical School; Former Associate Dean for Executive Education at Harvard Medical School.

Stanley Y. Shaw, MD PhD is currently Associate VP, Global Medical, Amgen; Executive Education Teaching Associate, Harvard Medical School. Previously, he served as the Associat...

Guest Faculty

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Kimberly McCleary

Founder & CEO,The Kith Collective

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Margaret Andrews

Instructor, Harvard University; Executive Education Teaching Associate, Harvard Medical School; Managing Director, The MYLO Center

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Andrew Beam, PhD

Chief Technology Officer, Lila Sciences; Associate Professor, Harvard Medical School

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Shaheen Lakhan, MD, PhD, FAAN

Neurologist, Pain Physician, Chief Medical Officer, Click Therapeutics

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Robert Chamberlain, PhD

SVP, AlixPartners

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Shamiram Feinglass, MD, MPH

Fellow, The Aspen Institute

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Arnaub Chatterjee, MHA, MPA

President and GM, Life Sciences, Ecosystem, Public Sector at Datavant; Teaching Associate, Harvard Medical School

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Justin Gainor, MD

Director, Center for Thoracic Cancers Program; Massachusetts General Hospital; Associate Professor of Medicine, Harvard Medical School

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Anupam Jena, MD, PhD

Joseph P. Newhouse Professor of Health Care Policy, Department of Health Care Policy, Harvard Medical School; Professor of Medicine and Associate Physician in the Department of Medicine, Massachusetts General Hospital; Host of Freakonomics, MD podcast

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Paul Eisenberg, MD, MPH

Venture Partner at Apple Tree Partners

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Certificate

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

FAQs

Didn't find what you were looking for? Write to us at learner.success@emeritus.org or Schedule a call with one of our Program Advisors or call us at +1 315 284 5718 (US) / +44 204 538 5575 (UK) / +65 3129 7741 (SG)

Flexible payment options are available.

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