Project Manager, IND Development
About The Position
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.
Requirements
- 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.
- Experience with navigating the complexities of bispecific antibody and novel payload development is preferred.
- Familiarity with biologic, small molecule, and combined regulatory considerations is a strong plus.
- Excellent organizational, communication, and stakeholder management skills, with strong attention to detail and problem-solving abilities.
- Demonstrated ability to build effective working relationships across technical domains.
- A track record of proactively learning new technical or therapeutic areas.
Nice To Haves
- Advanced degree or PMP certification preferred.
- Experience with GxP environments, 21 CFR, pre-IND meeting processes, and life sciences regulatory requirements preferred.
- Experience with navigating the complexities of bispecific antibody and novel payload development is preferred.
- Familiarity with biologic, small molecule, and combined regulatory considerations is a strong plus.
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.
Benefits
- Medical, Dental, and Vision plans
- company-paid holidays
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What This Job Offers
Job Type
Full-time
Career Level
Senior
