Job Details

About Soleno Therapeutics Inc

Soleno is a biopharmaceutical company focused on the development and commercialization of novel therapeutics for the treatment of rare diseases based in Redwood City, CA.

At Soleno, we are driven by the unique and multi-faceted needs of the PWS community. Like these individuals, resilience is part of who we are - it is in our chromosomes - and our team is made up of exceptional colleagues whose collective efforts are woven together to deliver meaningful outcomes, both professionally and for those living with PWS.

We value collaboration, integrity, and respect. These characteristics have allowed us to forge strong, authentic bonds with the caregivers, patients, health care professionals (HCPs) and community members we serve. We are proud to work alongside them every step of the way.

Our employees are our greatest asset, and we're expanding across functions during this pivotal time. We invite you to join us in making an impact-and making history.We all share the most important goal of bringing solutions to the PWS community.

Summary of Job (brief description)

The VP, Drug Discovery and Preclinical Development will lead the preclinical development efforts at Soleno Therapeutics. This role is critical in advancing the company's early development pipeline to the initiation of clinical development. The ideal candidate will have extensive experience in preclinical drug development within the biotech or pharmaceutical industry, with a focus on rare diseases, and a proven track record of bringing novel therapies to the clinic.

Responsibilities

• Leads and coordinates cross-functional teams and activities required to advance development candidates from acquisition or transfer from collaborators through IND acceptance by the FDA or other global health authorities.
• In conjunction with Finance and the SVP of Drug Development, develop the budget(s) for research collaborations and preclinical development programs; Responsible for on-budget execution.
• Effectively interacts with Regulatory to assemble submissions (meeting requests, briefing books, INDs, orphan drug applications, etc.), and participate with Regulatory in interactions with health authorities.
• Effectively coordinates and manages cross-functional team activities to achieve the company's development goals.
• Direct and manage non-clinical efforts required to support the ongoing development of pipeline candidates through NDA submissions.
• Collaborates with Commercial, Clinical, Finance, and the Drug Development team to evaluate preclinical candidates for potential acquisition or transfer from collaborators.
• Identifies opportunities for new intellectual property related to development candidates and collaborates with the SVP of Drug Development, General or IP Counsel, and external patent counsel to secure appropriate protections.
• Manage relationships with external partners, including CROs, academic institutions, and KOLs; Ensures all external collaborations support the company's drug development goals.
• Identify potential risks in drug development programs and develop mitigation strategies that address or manage these risks. Ensure that drug development activities adhere to the highest standards of quality and compliance.
• Help identify and contribute to the evaluation of externally sourced preclinical, clinical and commercial product candidates, consistent with corporate strategy and commercial viability.
• Stay up to date on advancements in drug development methodologies, technologies, and regulatory guidelines. Implement innovative approaches that enhance the efficiency, effectiveness, and likelihood of success, of the company's drug development programs.
• Contribute to the preparation of scientific publications, abstracts, and presentations for conferences and peerreviewed journals. Ensure the accurate and transparent communication of drug development data.

Qualifications

• 15+ years of experience in drug development within the biotech or pharmaceutical industry, preferably with a focus on rare diseases.
• Advanced degree (PhD or equivalent) in a relevant scientific discipline, preferably medicinal chemistry, pharmacology, or toxicology.
• Proven track record of leading successful preclinical drug development programs to IND acceptance.
• Extensive experience in managing preclinical drug development teams.
• In-depth knowledge of preclinical drug development processes, regulatory requirements, and CMC.
• Strong strategic thinking and problem-solving skills.
• Excellent leadership and team management abilities.
• Effective communication and presentation skills, with the ability to engage with internal and external stakeholders.
• Proficiency in project management and data analysis approaches relevant to preclinical drug development.
• High level of integrity and commitment to ethical standards.
• Collaborative and team-oriented, with a focus on achieving shared goals.
• Innovative mindset with a commitment to continuous learning and improvement.

Salary Range: $315,000 - $355,000

(Actual salary at the time of hire may vary and may be above or below the range based on various factors, including, but not limited to, the candidate's relevant qualifications, skills, and experience, as well as the location where this position may be filled.)