1 день назад
Early Development Program Lead – Cambridge (Biotechnology)
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Early Development Program Lead – Cambridge (Biotechnology): Leading early-stage small molecule and oligonucleotide drug development programs from late lead optimization through IND with an accent on cross-functional scientific strategy, translational development, and regulatory planning. Focus on integrating multidisciplinary data, coordinating CROs and CDMOs, managing program risks and milestones, and guiding teams toward candidate selection and first-in-human development.
Location: Fully remote; can be performed from anywhere. Occasional domestic and international travel of approximately 10% is expected for 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 early-stage drug development programs from late lead optimization through IND and first-in-human development.
- Coordinate cross-functional teams across medicinal chemistry, CMC, formulation, biology, toxicology, DMPK/ADME, translational science, regulatory, clinical, and patient advocacy.
- Define scientific strategies, early Target Product Profiles, project objectives, integrated plans, budgets, timelines, and risk registers.
- Integrate multidisciplinary data to support candidate selection and facilitate decisions across competing priorities.
- Manage CRO and CDMO relationships and oversee outsourced activities.
- Prepare program documents and updates for senior leadership, governance committees, and regulatory discussions.
Requirements
- PhD in Medicinal Chemistry, Pharmacology, Pharmaceutical Sciences, Translational Medicine, Biochemistry, or a related discipline relevant to small molecule or oligonucleotide drug discovery and development.
- 15+ years of pharmaceutical or biotechnology industry experience, including increasing responsibility.
- 5+ years of industry experience in small molecule drug 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 development.
- Experience engaging with FDA and EMA in early development settings, including pre-IND, INTERACT, and Type B/C meetings.
- Strong communication, influencing, alignment, 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 learning programs, external programs, LinkedIn Learning, and role-specific training.
- AI-powered and on-demand learning tools, including a digital assistant for internal resources.
- Technology and IT support for collaboration across locations and time zones, plus global recognition programs and Employee Resource Groups.
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