6 дней назад
Early Development Program Lead (Biotech)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Early Development Program Lead (Biotech): Leading scientific and operational development of early-stage small molecule and oligonucleotide programs from late lead optimization through IND with an accent on translational clinical science, cross-functional coordination, and regulatory alignment. Focus on integrating multidisciplinary data, driving candidate selection, managing scientific and CMC risks, and delivering milestones across complex drug development programs.
Location: Fully remote; can be performed from anywhere. Occasional domestic and international travel of approximately 10% is expected, including team meetings and events.
Company
is a global biopharmaceutical company developing therapies for patients with serious and rare diseases, including small molecule and oligonucleotide therapeutics.
What you will do
- Lead scientific and operational execution of one or more early-stage drug development programs from late lead optimization through IND.
- Coordinate cross-functional teams across medicinal chemistry, CMC, formulation, biology, toxicology, DMPK/ADME, translational science, regulatory, clinical, and patient advocacy.
- Define project objectives, early Target Product Profiles, scientific strategies, integrated plans, milestones, budgets, and risk registers.
- Integrate multidisciplinary data to support candidate selection and facilitate decisions across competing priorities.
- Manage relationships with CROs and CDMOs and oversee outsourced development activities.
- Prepare program documents and present status, risks, scientific findings, and recommendations to senior leadership and governance committees.
Requirements
- PhD in Medicinal Chemistry, Pharmacology, Pharmaceutical Sciences, Translational Medicine, Biochemistry, or a closely related discipline.
- 15+ years of experience in the pharmaceutical or biotechnology industry with increasing responsibility.
- 5+ years of industry experience in small molecule and/or oligonucleotide therapeutic discovery and development.
- Experience leading cross-functional drug development matrix teams and advancing programs from lead optimization through IND and into first-in-human studies.
- Experience engaging with FDA and EMA in early development settings, including pre-IND, INTERACT, and Type B/C meetings.
- Strong communication, influence, risk management, and complex decision-making skills in a matrix environment.
Culture & Benefits
- Flexible work schedules with purposeful in-person collaboration.
- Competitive retirement benefits, global equity awards, and participation in the Employee Stock Purchase Plan.
- Career development through internal and external learning programs, LinkedIn Learning, and role-specific training.
- AI-powered and on-demand learning tools and digital internal-resource support.
- Hybrid-friendly technology and IT support for collaboration across locations and time zones.
- Global recognition programs and Employee Resource Groups.
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