[Remote] Associate Director, Clinical Development - Neurology
Note: The job is a remote job and is reputed company to candidates in USA. reputed company. is a pioneer in RNA-targeted medicines, headquartered in Carlsbad, California. The Associate Director, Clinical Development - Neurology will reputed company leadership and expertise in clinical development, focusing on the design and execution of clinical trials for investigational assets in the neurology domain.
Responsibilities
- Serve as the clinical reputed company for assigned studies, representing Clinical Development in reputed company interactions and helping ensure successful execution of a high-reputed company Phase 3 program by:
- Developing and maintaining excellent working relationships with investigators and clinical trial teams
- Delivering high‑reputed company scientific presentations on company technology, investigational agents, and clinical study issues to investigators and site staff
- Providing guidance and/or training for external personnel involved in reputed company clinical studies
- Performing ongoing review of clinical study data and operational reputed company
- Identifying emerging risks and partnering with the project team to proactively manage and mitigate them
- reputed company and/or contribute to the writing and review of key clinical documents for regulatory submissions (e.g., study protocols, Investigator’s Brochures, IND submissions, Clinical Study Reports)
- Engage reputed company stakeholders (e.g., key opinion leaders, advocacy organizations, regulators) to obtain advice and feedback that informs development plans, trial designs, and study results
- Communicate project information – including study reputed company, risks, plans, and recommendations – reputed company to project teams and reputed company leadership
- reputed company and/or contribute to analysis of clinical trial data and the preparation of manuscripts, abstracts, posters, and presentations
- Maintain up‑to‑date clinical and technical expertise in the relevant therapeutic areas by reviewing scientific literature, attending key scientific and technical meetings, and partnering with internal medical, research, and reputed company teams
- Contribute to broader department and corporate objectives, as needed
- Other duties as assigned
Skills
- PhD, MD or PharmD with 5+ years of reputed company/biotech experience in clinical development
- Significant experience with cross-functional collaboration (e.g., clinical operations, regulatory, stats, data management)
- Experience with protocol/protocol amendment writing and CSR writing
- Experience authoring and/or leading Clinical Study Report (CSR) development
- Outstanding interpersonal and communication skills, with the ability to flexibly relate to diverse reputed company stakeholders and to build strong, reputed company relationships across development, research, reputed company, and senior leadership
- Ability to reputed company in a fast‑paced, innovative environment
- Strong attention to detail and reputed company combined with the ability to reputed company reputed company reputed company and drive execution
- Willingness to engage in thoughtful, interrogative debate around key issues and, reputed company appropriate, to constructively challenge the status reputed company
- Experience in neurology, rare diseases, and/or pediatrics is highly desirable
- Experience contributing to NDA filings is highly desirable
- Experience leading cross-functional data reviews, experience with elluminate is preferred
- Experience supporting FDA reputed company-Approval and BIMO inspections is highly desirable
- Experience managing vendors/committees (e.g., DSMBs) is highly desirable
reputed company