- The opportunity to lead a potential best in class asset with potential to transform standard of care for individuals with sleep-wake disorders
- A high-impact role that will shape and lead the clinical strategy of Centessa's flagship asset, ORX-750, including expansion into broader CNS disorders
- A lean, fast-paced organization in growth mode with the need for neurology expertise and leadership both internally and externally
- A collaborative, agile, and data- & patient-driven culture
- A remote working environment
- Author clinical study protocols for orexin agonists for the initial indication of narcolepsy, while expanding into other CNS disorders
- Provide scientific and medical expertise to effectively execute clinical studies and advance accelerated development programs
- Leadership to develop the design of a cross-functionally aligned clinical development plan to advance multiple orexin agonist candidate molecules
- Collaborate with clinical operations to meet timeline, cost and quality performance expectations and achieve program milestones
- Provide medical insight and leadership in the design of translational medicine approaches exploring indication expansion opportunities
- Effectively communicate and collaborate across internal disciplines and with key external partners/experts/investigators to position orexin agonist programs at the forefront of research and development for new medicines in sleep disorders
- Provide oversight of study integrity and timelines, and communication of information pertaining to safety and efficacy of clinical candidate molecules
- Author/ review clinical sections of regulatory documents, clinical study reports, scientific publications and presentations, and other program documents
- Ensure adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and quality standards in conducting clinical research
- MD with a Board Certification in neurology preferred
- Clinical and/or academic experience in neurological disorders; and 5+ years of pharmaceutical industry experience
- Experience in early clinical development through late stage with successful design and implementation of proof-of-concept studies; submission experience in the neuroscience area is highly desired
- Knowledge of US and EU regulatory guidelines and experience in interactions with regulatory agencies
- Outstanding written and verbal communication, with a passion for problem solving and effective cross-functional stakeholder engagement
- Ability to work independently and thrive in a fast-paced dynamic matrix environment
- An entrepreneurial spirit with high degree of energy and personal accountability
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Centessa Pharma- Vice President, Clinical Development - Boston, United States - The Higgins Group, Inc.
3 weeks ago
Description
THE POSITION
The Vice President, Clinical Development will play a leadership role in devising the strategy for Centessa's expansion into broader CNS indications with oversight of their flagship orexin agonist program. The initial indication is for narcolepsy, entering FIH this year (IND cleared recently), with the broader goal of owning the orexin space and moving into additional neurological disease areas. The role will work closely with cross functional team members to execute all activities associated with study conduct and interpretation of data from clinical trials. This individual will engage key external partners in the medical and scientific community and will provide medical expertise to support regulatory submissions and interactions with global regulatory authorities. This individual will need to demonstrate strong hands-on leadership, communication, and relationship building skills to drive results in a matrixed environment. This is a highly visible role that will impact and help shape the direction and success of the company.
This position is ideal for those seeking:
Key responsibilities include:
The ideal candidate will have the following mix of personal and professional characteristics:
COMPANY OVERVIEW
Centessa discovers and develops medicines that are transformational for patients. The company operates its clinical research with the conviction that each one of the programs has the potential to change the current treatment paradigm and establish a new standard of care. Centessa aims to achieve this patient-centric mission with a focus on developing a portfolio of highly innovative assets, unconstrained by therapeutic area or technology.
Centessa's core medical research operating principle is to make timely, unbiased decisions driven by data and biology. The company focuses on making the best decisions for each asset without constraints or bias stemming from the needs of other programs in the portfolio. Centessa is confident this unencumbered, asset-centric philosophy has the potential to deliver significant value for all stakeholders.
SCIENCE AND PIPELINE
Centessa's programs span discovery-stage to late-stage development and cover a range of high-value indications. The company aims to pursue programs it believes could be first-in-class / best-in-class and where there is prior learning in human genetics or precedented human activity for a pathway of interest. Centessa places a premium on learnings from its clinical trials, whereby a drug has established the relevance of a biological pathway contributing to disease outcome. The approach is to pursue the best assets in a capital efficient manner and rapidly progress programs through development, evaluating the unique biological advantage of product candidates.
ORX750 OVERVIEW
Centessa is developing ORX750, an oral selective orexin receptor 2 (OX2R) agonist designed to leverage unique structural insights and to directly target the underlying pathophysiology of orexin neuron loss in NT1 with plans to expand into broader neurological diseases.
