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Soleno Therapeutics, Inc. · 3 months ago

Director, Clinical Development

Redwood City, CA

Full-time

Onsite

Director/Executive

$280K/yr - $305K/yr

Soleno 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) and will manage all phases of clinical drug development, collaborating with various departments and stakeholders.

BiotechnologyMedicalPharmaceutical

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

Clinical drug developmentINDNDA submissionsMedical monitoringPharmacovigilancePediatric endocrinologyRare disease experienceLeadership experienceCommunication skillsInterpersonal skillsPresentation skills