Head of Clinical Development

4 weeks ago

Cambridge, United States VALID8 Financial Full time

Walden Biosciences’ mission is to transform the treatment of kidney disease by reversing its 
progression and enabling patients to resume their normal lives. Walden is a private, Series B, 
venture-backed biopharmaceutical company developing first-in-class, highly targeted, 
disease-modifying therapies for individuals living with kidney disease.
Walden’s most advanced programs address two novel targets: soluble urokinase plasminogen activating receptor (suPAR) and dynamin. Modulation of both of these targets is expected to provide a significant improvement for multiple kidney diseases. As a member of the Walden Team, you will have an important role in helping to bring this mission to life.

Walden has state of the art laboratory facilities located in the heart of Kendall Square in 
Cambridge, Massachusetts. For more information, please visit www.waldenbiosciences.com


Job Summary

The Head of Clinical Development will design, lead the execution, and ensure the completion of 
clinical studies of Walden’s disease modifying agents addressing chronic kidney disease (CKD) over the products lifecycles. The successful candidate will have experience and have demonstrated leadership in industrial clinical development. The successful candidate will collaborate with the leaders of the regulatory and medical affairs functions at Walden as well as with external CRO(s). The Head of Clinical Development will report directly to the Chief Executive Officer and have frequent direct interaction with all levels of the Walden team and Board of Directors, external stakeholders, and regulatory authorities.


Responsibilities

  • Responsible for the strategic design and execution of the clinical development strategy of early assets based on deep scientific and medical understanding and translational expertise, including patient safety, data integrity and a strong focus on the rapid and cost effective, and successful execution of clinical trials for Walden’s programs
  • Serve as a member of the Walden’s Product Development Teams, working cross functionally with internal and external stakeholders regarding design and execution of clinical studies
  • Serve as a member of the Senior Leadership Team and provide enterprise-wide clinical perspective on Walden’s research and development programs, potential in-licensing transactions, and general corporate governance
  •  Draft and manage clinical content of all clinical and regulatory documents, ensuring effective technical review of clinical plans and protocols
  • Generate and manage the clinical development budget, lead the oversight of quarterly financial forecasts for the Clinical function, and provide comprehensive input to the long-range financial and strategic plans at Walden
  • Manage Walden’s compliance with all relevant external guidelines and regulations
  • Act as the principal point of contact for Walden with internal and external collaborators across the medical/scientific community, facilitating coordination, fostering collaboration, and developing and maintaining a leading-edge perspective of the evolving science and clinical research landscape

Education, experience, and competencies

  • MD or MD/Ph.D. with substantial industrial experience in the design, execution, and interpretation of early development and late-stage clinical trials
  • At least five years of active industrial clinical experience designing and executing clinical trials. Specific expertise and experience in renal or orphan diseases is preferred
  • Strong oral and written communication skills, as evidenced by a record of publications and public speaking
  • Strong financial management skills
  • A keen understanding of clinical study design principles, and a thorough understanding of all phases of industrial drug development
  • Knowledge of regulatory requirements, good clinical practices, and pharmaceutical clinical development
  • A track record demonstrating the analytical, problem-solving, and strategic planning skills necessary to plan and conduct clinical trials, deliver high quality results within established timelines, along with the ability to interpret,analyze, and communicate clinical/scientific data, and generate clinical/scientific documents
  • Experience working in a team setting, and the ability to facilitate productive exchanges with team members at all levels through strong management, leadership, mentoring, and motivating
  • Experience leading external CRO and similar vendors in support of internal clinical and regulatory matters
  • Ability to work independently and thrive in a fast-paced environment, with a sense of passion and urgency to achieve goals and improve patient outcomes
  • Belief in Walden’s core values of Data, Innovation, Teamwork, Agility, Perseverance, and Fun
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