7 дней назад
Executive Director, Pharmaceutical Development (Small Molecule)
247 000 - 337 000$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Executive Director, Pharmaceutical Development (Small Molecule) (CMC/Pharmaceutical Development): Leading formulation, drug product development, manufacturing readiness, and CMC strategy for a small-molecule pipeline with an accent on regulatory alignment, commercialization, and advanced manufacturing technologies. Focus on driving cross-functional development from early-stage programs through commercialization, solving complex formulation and process challenges, and building scalable pharmaceutical development capabilities.
Location: Fully remote and available from anywhere; occasional travel for team meetings or events is expected, approximately 25%.
Salary: $247,000–$337,000 annual.
Company
is a global biopharmaceutical company developing treatments for patients with serious and rare diseases.
What you will do
- Lead the strategic direction and operating model for small-molecule Pharmaceutical Development within Technical Operations.
- Oversee formulation development, drug product process development, technology transfer, process validation, manufacturing readiness, and lifecycle management.
- Support global CMC regulatory strategies and development and commercialization plans for oral, parenteral, combination, and other advanced dosage forms.
- Evaluate emerging formulation technologies, advanced manufacturing approaches, digital tools, and external scientific partnerships.
- Build relationships with CDMOs, technology partners, regulatory agencies, academic institutions, and industry experts.
- Develop organizational talent, establish performance frameworks, and drive operational excellence and continuous improvement.
Requirements
- PhD with 10 years of CMC experience, MS with 12 years, or BS with 15 years of pharmaceutical-industry CMC experience.
- Extensive expertise in formulation development, process development, technology transfer, process validation, manufacturing sciences, regulatory strategy, and commercialization readiness.
- Experience with solid oral and liquid dosage forms, including pediatric, geriatric, and modified-release products.
- Strong understanding of cGxP, CMC, ICH, and USP/EP/JP requirements, with experience authoring, reviewing, and approving CMC sections of INDs, NDAs/MAAs, and related submissions.
- Demonstrated leadership across multiple programs, resources, and staff from early discovery through commercialization.
- Exceptional communication, negotiation, and influencing skills with executives, regulators, external partners, and scientific organizations.
Nice to have
- Experience with inhalation and combination products.
Culture & Benefits
- Fully remote work with purposeful in-person collaboration and occasional travel.
- Medical, dental, vision, and mental health support, plus an annual wellbeing reimbursement and EAP access.
- Paid time off, fertility and family-forming benefits, caregiver support, and flexible work schedules.
- 401(k) matching, annual equity awards, ESPP participation, and company-paid life and disability insurance.
- Learning programs, leadership development, mentorship, employee resource groups, and service opportunities.
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