What are the responsibilities and job description for the SVP, Product Development position at Elion Therapeutics?
Senior Vice President, Product Development
Position Summary
Elion Therapeutics is a fast-paced, science-driven biotechnology company focused on combating life-threatening invasive fungal infections. Our goal is to provide patients and clinicians with new antifungal therapies that address critical unmet needs. Our depth and breadth in the antifungal space uniquely positions Elion for success in this mission. We are seeking passionate leaders who thrive in a fast-paced, mission-driven environment.
The SVP, Product Development will be directly responsible, from a CMC and nonclinical perspective, for driving product candidates through early development, from discovery through nonclinical, CMC, regulatory preparation, and into clinical trials. Reporting directly to Elion’s CEO, this role will play a hands-on leadership role in shaping the formulation and delivery strategy, including IV and inhalation/aerosol-based systems, ensuring scalable, patient-centric solutions aligned with Elion’s objectives.
The ideal candidate brings deep expertise in sterile injectable and inhaled anti-infective product development, with a proven track record of advancing programs through regulatory milestones, manufacturing scale-up, and clinical execution.
Key Responsibilities
- Oversee all aspects of CMC development, including formulation, process development, analytical methods, manufacturing, and supply chain to support clinical and commercial development of Elion’s antifungal candidates.
- Oversee nonclinical development activities including pharmacology, PK/PD, and toxicology, translating discovery insights into development-ready candidates.
- Drive development and optimization of IV and inhaled/aerosol delivery systems, ensuring product stability, scalability, and patient usability.
- Manage external development partners including CDMOs, CROs, and testing labs to support GMP manufacturing, product release, and supply chain operations.
- Ensure development plans meet global regulatory standards supporting successful IND/CTA submissions.
- Identify and address capability gaps across CMC and nonclinical functions; implement solutions to support growth and program success.
- Collaborate with Clinical Operations to ensure alignment of clinical supply and commercial readiness.
- Build and lead a high-performing team, including internal staff, consultants, and external partners; provide coaching, mentorship, and professional development.
- Contribute to strategic planning, including portfolio development, lifecycle management, combination product strategy, and budget oversight.
- Work cross-functionally with Regulatory, Quality, Clinical, and commercial teams to align development efforts with company goals.
Qualifications
- Ph.D. in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related life science discipline required.
- 15 years of experience in pharmaceutical development, with at least 5 years in a senior leadership role in product development or CMC.
- Proven experience leading drug product development with IV formulations and inhaled/aerosol delivery systems (e.g., nebulizers, dry powder inhalers, metered dose inhalers); experience managing CDMOs/CMOs and global supply chains is a plus.
- Background in process development, scale-up, and technology transfer.
- Background in nonclinical studies to support first-in-human to NDA.
- Demonstrated success in regulatory filings and interactions (IND/CTA, BLA/NDA).
- Excellent leadership, strategic thinking, and communication skills to partner with stakeholders and present information with impact.
- Ability to thrive in a fast-paced, entrepreneurial, and collaborative environment.
- Previous work in a small or mid-sized clinical-stage biotech company.
Location
- Boston-based hybrid position
