Project Manager, IND Development

Overview:

The Senior Project Manager will support the advancement of Sidewinder Therapeutics' antibody-drug conjugate (ADC) pipeline by driving cross-functional project planning and execution from discovery through IND submission. This role is crucial in enabling Sidewinder Therapeutics’ first-in-human clinical trials. The Senior Project Manager must have substantial experience managing the intersection of complex programs across multiple domain-based biotech teams (e.g., Toxicology, Pharmacology, Bioanalytical, CMC, Regulatory Affairs, and Quality Control). The ideal candidate approaches unfamiliar technical areas with high curiosity. They prioritize credibility and co-elevation to organize and advance their colleagues' technical expertise and to evolve the organization's broader priorities.

Key Responsibilities:

• Provide leadership and proactive mitigation by maintaining and communicating program risk registers, decision logs, and cross-functional action items.
• Lead cross-functional core team meetings that maintain alignment across workstreams and shared milestones.
• Own integrated development timelines connecting all drug development teams as well as external CRO/CDMO partners (e.g., nonclinical/toxicology, bioanalytical method development, regulatory submissions, etc.)
• Possess exceptional organizational and communication skills to track and elevate cross-team dependencies and risks specific to ADC development.
• Support preparation and coordination of IND-enabling documents, regulatory submissions, governance meetings, and program reviews.
• Track project metrics, maintain project documentation, and ensure activities are conducted in accordance with company processes and regulatory expectations.
• Extend project management support to additional company priorities and programs by applying the same rigorous, collaborative coordination to company decision-making.

Qualifications:

• Bachelor's degree in a scientific discipline; advanced degree or PMP certification preferred.
• 7+ years of project management experience within biotechnology or pharmaceutical development, including experience supporting IND-enabling programs.
• Working knowledge of CMC development for ADCs, biologics, and/or small molecules (e.g., conjugation chemistry, analytical characterization, drug product formulation).
• Familiarity with GLP toxicology study design and nonclinical development timelines.
• Experience managing cross-functional drug development teams (i.e., internally and CROs/CDMOs) with a track record of successful IND submissions.
• Experience with GxP environments, 21 CFR, pre-IND meeting processes, and life sciences regulatory requirements preferred.
• Strong understanding of FDA regulations, ICH guidelines, and pharmaceutical development processes.