Clinical Development Leader
4 weeks ago
We are seeking a highly skilled Clinical Development Leader to join our team at Chiesi USA. As a key member of our R&D department, you will play a critical role in defining the target disease profile, target product profile, and development and life cycle strategies for our projects.
As a Clinical Development Leader, you will lead the Clinical Development Team in the design and execution of the clinical development plan from Phase I to Phase IV. You will be responsible for all clinical aspects related to the Clinical Trial Dossier, including clinical modules, briefing books, scientific advice, meetings with regulatory agencies, and more.
You will serve as the principal internal clinical resource for R&D concerning the disease area and project, working with other members of the Core Team to raise disease awareness and product knowledge levels within Chiesi.
Key Responsibilities:
- Develop the Target Product Profile and Clinical Development strategy as a member of the Core Team
- Coordinate alignment and agreement on Clinical Development Plan matters with the Clinical Development Team, Core Team, and Global Clinical Development Leadership Team
- Ensure that the design of each clinical study is consistent with the Clinical Development Plan
- Ensure that the Clinical Development Plan is in line with the approval path agreed with Regulatory Agencies and with the agreed business plan and objectives
- Provide clinical approval for protocols, CSRs, lay summaries, clinical trial disclosure and/or deferral strategy, data sharing requests
- As part of the Submission Team, prepare/review Briefing Books, eCTD modules, and represent clinical aspects during interaction with Regulatory Authorities
- Regularly update the Clinical Development Team on all aspects discussed at Core Team or internal bodies
- Secure necessary internal approvals and external endorsement (e.g., disease area experts, consultants) to Clinical Development Plan elements
- Ensure accurate and timely documentation of all actions and decisions related to the Clinical Development Plan
Requirements:
- Significant experience in designing and executing a comprehensive clinical research and development plan
- At least 5 years in an R&D role in the pharmaceutical/biotech industry, or 7-10 years in academia with clinical investigator track record
- Experience within the respiratory therapeutic area is highly preferred
- Fluent written and verbal communication skills in English
- Ability to interact with academic and regulatory experts with confidence, integrity, and persuasion
- Strong business acumen, able to see the big picture and weigh pros and cons and drive towards an informed decision
- Strong ability in analyzing and interpreting complex data sets
- Leading a cross-functional team, working in a matrix environment, problem-solving, motivating team members, and providing a safe environment for the expression and exchange of innovative thoughts and ideas
- Courage to take initiative and learn from failures and setbacks
- Excellent communication with peers, stakeholders, Sr. managers, and teammates
What We Offer:
Chiesi USA is a specialty pharmaceutical company focused on developing and promoting products for the hospital, adjacent specialty, and rare disease markets. We offer a competitive benefits package, opportunities for professional growth and development, and a collaborative work environment.
Join our team and contribute to the development of innovative treatments that improve the lives of patients worldwide.
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