Soleno Therapeutics, Inc. · 9 hours ago
Director, Clinical Development
Redwood City, CA
Full-time
Onsite
Director/Executive
$280K/yr - $305K/yrSoleno Therapeutics, Inc. is a biopharmaceutical company focused on the development and commercialization of novel therapeutics for the treatment of rare diseases. The Director, Clinical Development will be responsible for the development of the company’s drug candidate(s), with a strong understanding of all phases of clinical drug development and collaboration with various stakeholders.
BiotechnologyHealthcarePharmaceuticalMedical
Responsibilities
Develop and implement clinical strategies to support the company’s rare disease program(s), ensuring alignment with overall corporate objectives
Support the design and execution of clinical development plans, including the planning and hands-on execution of clinical trials
Work cooperatively with Clinical Operations, CROs, and external vendors to implement clinical studies (e.g. lead from study start-up through database lock; review and draft start-up documents/study manuals; perform ongoing data review/analyses; and draft and present clinical information to Investigators and advisory panels as required)
Provide clinical expertise and strategic medical input for clinical deliverables. Clinical deliverables may include, but are not limited to, protocols, statistical analysis plans, regulatory documents/registration dossiers, and scientific publications
Support the development of the clinical sections of regulatory documents in support of submissions, including INDs, NDAs, urgent information requests, and other submission packages to global health authorities, as required
Function as medical monitor and internal subject matter expert, ensuring the overall safety of drug candidate(s), while supporting pharmacovigilance functions (e.g., IND safety updates, PADERs, PBRERs, Drug Safety Update Reports [DSURs], and other safety updates)
Actively seek and maintain credible relationships with Key Opinion Leaders (KOLs), Investigators, and patient advocacy groups
Other duties commensurate with position and experience, as assigned
Qualification
Required
Board certified/board eligible physician
Training and/or experience in pediatric endocrinology desired
Demonstrated ability to independently evaluate, interpret and present complex clinical and scientific data
Demonstrated ability to critically evaluate complex drug development programs
Rare/orphan disease (Prader-Willi syndrome) experience desired
Team player with proven leadership experience
Demonstrated ability to work within a fast-paced, multi-disciplinary team of peers and outside experts
Excellent communication, presentation, and interpersonal skills
Company
Soleno Therapeutics, Inc.
At Soleno Therapeutics, we believe in the power of science, advocacy, and community.
Founded in 1999
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$569.2MKey Investors
Oxford Finance LLCAbingworth
2025-07-10Post Ipo Equity· $200M
2024-12-17Post Ipo Debt· $50M
2024-05-02Post Ipo Equity· $158.7M
Leadership Team
Jim Mackaness
Chief Financial Officer
Recent News
Company data provided by crunchbase