VP, Development

Genepool Networks; Boston (MA); In loco; USD 250.000 - 420.000; Tempo pieno

Descrizione del lavoro

GenepoolNetworks is seeking a VP, Development to lead its first therapeutic program from nomination to IND-enabling studies and IND submission. This hands-on leader will shape the development strategy and drive cross-functional execution in a fast-growing biotech environment.

The ideal candidate has a PhD and a track record of advancing therapeutic candidates into the clinic, with deep expertise in biologics, nonclinical pharmacology, GLP toxicology, CMC, and regulatory planning.

Competenze

• PhD in a relevant scientific discipline.
• Demonstrated track record of advancing therapeutic candidates from development candidate nomination through IND submission.
• Experience in biologics development and cross-functional program leadership.

Mansioni

• Lead the advancement of biologics programs from nomination through IND-enabling studies and IND submission.
• Develop and execute integrated development plans covering nonclinical pharmacology, toxicology, CMC, regulatory strategy, and clinical readiness.
• Drive IND-enabling activities, overseeing study design, timelines, and milestones.
• Lead regulatory development strategy, including IND submissions and regulatory interactions.
• Oversee external CROs, CDMOs, and development partners to ensure program success.
• Build and lead a lean development organization to advance programs into the clinic.

Conoscenze

Strategic development

Cross-functional leadership

IND regulatory planning

Biologics development

Team leadership

Formazione

PhD in a relevant scientific discipline

Descrizione del lavoro

We are partnering with an innovative, early-stage biotechnology company seeking a VP, Development to lead its first therapeutic program from development candidate nomination through IND-enabling studies, IND submission, and preparation for clinical entry.

This individual will serve as the company's senior drug development leader, responsible for establishing and executing an integrated development strategy spanning nonclinical development, toxicology, CMC, regulatory planning, and clinical readiness. This is a hands‑on leadership opportunity for someone who thrives in an entrepreneurial environment and has a demonstrated track record of advancing drug candidates into the clinic.

Key Responsibilities

• Lead the advancement of a biologics program from development candidate nomination through IND-enabling studies and IND submission.
• Develop and execute integrated development plans encompassing nonclinical pharmacology, toxicology, CMC, regulatory strategy, and clinical readiness.
• Drive IND-enabling activities, overseeing study design, execution, timelines, and key development milestones.
• Lead regulatory development strategy, including preparation of IND submissions and interactions with regulatory authorities.
• Oversee external CROs, CDMOs, and development partners to ensure successful program execution.
• Build and lead a lean development organization, establishing the capabilities and resources needed to advance programs into the clinic.
• Partner closely with executive leadership to guide development decisions, manage program risks, and support broader pipeline strategy.

Qualifications

• PhD in a relevant scientific discipline.
• Significant drug development experience with a demonstrated track record of advancing therapeutic candidates from development candidate nomination through IND submission.
• Strong understanding of IND-enabling development, including nonclinical pharmacology, GLP toxicology, regulatory requirements, and cross-functional development planning.
• Biologics development experience required, with familiarity across CMC and manufacturing activities.
• Experience working in an early- or mid-stage biotechnology environment, with the ability to operate both strategically and hands‑on.
• Experience in immunology, autoimmunity, or T-cell-directed therapeutics preferred.
• Demonstrated ability to build development functions and lead cross‑functional teams.