Senior Director, Regulatory Combination Product
Abata TherapeuticsSalary not specified
Full Time
Senior (5 to 8 years), Expert & Leadership (9+ years)
Executive Director, Combination Product Development at Gilead Sciences
Parsippany, New Jersey, United States
Not SpecifiedCompensation
Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceuticals, BiotechnologyIndustries
Requirements
- Technical expertise in combination product development, including drug-device systems and CMC programs
- Fluency in a matrixed environment with mastery of stakeholder alignment
- Regulatory acumen for compliance with FDA, EMA, PMDA, and other global authorities
- Experience managing external partners (CMOs, CDMOs, academic institutions, technology licensors)
- Leadership skills to lead multidisciplinary teams (engineering, formulation, clinical, regulatory, quality, manufacturing, supply chain, marketing)
- Ability to drive joint development agreements, technology transfers, and co-investment opportunities
- Passion, ambition, and relentless drive as a people leader fostering inclusion, development, and empowerment
Responsibilities
- Develop and execute the global combination product development strategy, linking to corporate objectives, therapeutic priorities, and market demands
- Cultivate and manage strategic relationships with external development partners to accelerate innovation, ensure alignment, and optimize resources
- Lead and align multidisciplinary teams within the Gilead ecosystem to achieve milestones on time, on budget, and within risk thresholds, including alignment with PDM stakeholders
- Oversee design, development, and integration of drug-device systems, managing CMC programs from feasibility to commercialization
- Partner with global regulatory (clinical and CMC) teams for combination product development and compliance
- Oversee preparation, review, and approval of regulatory submissions (INDs, NDAs, PMAs, 510(k)s, MAAs), including CMC sections, lifecycle maintenance, and post-market surveillance
- Serve as primary technical interface with health authorities, fostering proactive interactions and championing novel pathways
- Provide strategic oversight for late-stage development and commercialization readiness, ensuring robust risk management
Skills
Combination Product Development
Device Development
Packaging Development
Process Development
Regulatory Compliance
Stakeholder Management
Matrixed Environment
Global Commercialization
Technical Strategy
Quality Standards
Gilead Sciences
Develops and commercializes biopharmaceuticals
About Gilead Sciences
Gilead Sciences focuses on discovering, developing, and commercializing medicines for various medical conditions, including HIV/AIDS, liver diseases, cancer, inflammatory and respiratory diseases, and cardiovascular issues. The company conducts extensive research and development to create new therapies, which are then marketed to healthcare providers, hospitals, and pharmacies after receiving regulatory approval. Gilead differentiates itself from competitors through its strong commitment to R&D and strategic partnerships, such as with SAP Ariba, to enhance its operations and product offerings. The company's goal is to improve health equity and access to care globally, working with communities to ensure that its medicines reach those in need.
Foster City, CaliforniaHeadquarters
1987Year Founded
$15,873.6MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
10,001+Employees