Walden Biosciences’ mission is to transform the treatment of kidney disease by reversing its progression and enabling and inspiring patients to resume their normal lives. As a member of the Senior Leadership Team at Walden, the Head of Clinical Development will play a pivotal role in bringing this mission to life.
The Head of Clinical Development will focus on leading, designing, and conducting clinical trials to support the development of first-in-class, highly targeted therapies for individuals with acute kidney injury (AKI) or living with chronic kidney disease (CKD) from IND through NDA/BLA and post-approval trials. The successful candidate will demonstrate a depth of experience and leadership in clinical research. In parallel with the responsibility for all clinical development activities at Walden, the successful candidate will be responsible for leading the regulatory and medical affairs activities at Walden as well as leading the interface with external CRO(s) that will conduct the regulatory, clinical, and clinical operations activities in support of Walden’s programs. Activities include direct responsibility for advancing high priority clinical programs resulting in regulatory approval, development of biomarker strategies, interpretation of data from key clinical studies, and finding ways to expedite and improve the execution of clinical trials. 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. This position will also provide clinical expertise and guidance to Walden’s preclinical programs and aid in the analysis of potential in-licensing opportunities.
· Serve as a member of the Senior Leadership Team and provide enterprise-wide clinical perspective on Walden’s ongoing research and development programs, potential in-licensing transactions, and general corporate governance.
· Strategically manage clinical trials throughout the conception, definition, and evolution of clinical trial design, ensuring timely execution and completion of the study/studies and providing medical, regulatory, and technical guidance throughout the process.
· Draft and manage clinical content of all clinical and regulatory documents, ensuring effective technical review of clinical plans and protocols.
· Design clinical programs in kidney disease areas that meet the highest scientific standards, applying best practices and successfully addressing emerging medical needs.
· Manage Walden’s compliance with all relevant external guidelines and regulations.
· Provide strategic leadership for programs that integrate the Head of Clinical Development’s extensive knowledge in clinical research with the latest knowledge from the global medical community.
· Provide leadership in the development and implementation of Walden’s long-range strategy in renal disease.
· Provide input into clinical research strategy and optimize new product development for successful launch into the marketplace.
· 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.
The successful candidate must have:
· MD or MD/Ph.D. with substantial industrial experience in design, execution, and interpretation of early development and late-stage clinical trials.
· At least three years of active industrial clinical experience designing and executing clinical trials. Specific expertise and experience in renal disease preferred.
· Strong oral and written communication skills, as evidenced by a record of publications and public speaking.
· 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.
· Demonstrable track record of the analytical, problem-solving, and strategic planning skills necessary to plan and conduct clinical trials, deliver high quality results within established timelines, 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, and Teamwork.
Based in the heart of Cambridge, MA, Walden Biosciences is developing first-in-class, highly targeted therapies for individuals living with kidney diseases. Our approach is different -- we utilize a deep mechanistic understanding of kidney function in health and disease, knowledge of novel biological pathways critical in regulating kidney function, and take a systems-based approach to translation into drug development. Our goal is to provide patients with real treatment options where currently few exist, and none of which target the kidney at the site of drug action.
Our culture is collaborative and entrepreneurial; we are driven by data and innovation. Our team is dynamic and has a successful track record in drug discovery. We strive to make the best decisions with the best available information, lead by example, and bring transformative medicines to patients in need.