Senior Director, Clinical Development

Centessa Pharmaceuticals Plc•Boston, MA

50d•$235,000 - $310,000•Remote

About The Position

Centessa Pharmaceuticals plc (Nasdaq: CNTA) new kind of pharmaceutical company with a deconstructed R&D environment that prioritizes data driven decision making led by subject matter experts. Centessa is advancing a portfolio of high conviction programs with strong biological validation. Our asset-centric model offers a unique R&D logic that has been applied by single asset companies to improve productivity. This operating model has minimal centralized infrastructure, reduced hierarchy, and exclusive focus on data driven capital allocation. Our teams are uniquely incentivized to expeditiously interrogate key scientific hypotheses. We believe the asset-centric model can lead to improved success rates for programs with greater speed and modest costs. Description of Role The Senior Director, Clinical Development will play a leadership role in Centessa's development of sleep-wake disorders and other CNS indications. Reporting to our Senior Vice President, Clinical Development, this individual 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: The opportunity to lead a potential best in class asset with potential to transform standard of care for individuals with sleep-wake disorders and other CNS indications A lean, fast-paced organization in growth mode with the need for CNS expertise and leadership both internally and externally A collaborative, agile, and data- & patient-driven culture A remote working environment

Requirements

MD in neurology or psychiatry (board certification 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 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

Nice To Haves

Translational medicine expertise highly desired

Responsibilities

Author clinical study protocols for orexin agonists
Provide scientific and medical expertise to effectively execute clinical studies and advance accelerated development programs
Contribute 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

Benefits

In addition to base pay, this role is eligible for a discretionary annual bonus and participation in our equity program, allowing you to share in Centessa's long-term success.
Centessa also offers a comprehensive benefits package, which includes a 401(k) plan, company-sponsored medical, dental, vision, and life insurance, generous paid time off, and a health and wellness program.

Stand Out From the Crowd

Upload your resume and get instant feedback on how well it matches this job.

Upload and Match Resume