Theseus Pharmaceuticals is passionately committed to improving the lives of cancer patients by working to outsmart cancer resistance. Led by a team of targeted oncology pioneers with a proven track record developing and commercializing cancer therapeutics, we are developing the next generation of tyrosine kinase inhibitors (TKIs): “pan-variant” targeted therapies that address all known drug resistant mutations. We believe a pan-variant approach is the only way to address cancer resistance. Our lead program, THE-630, is a pan-variant KIT inhibitor for patients with advanced gastrointestinal stromal tumors (GIST), whose cancer has developed resistance to earlier lines of kinase inhibitor therapy. We are also developing a fourth-generation, selective epidermal growth factor receptor (EGFR) inhibitor to address C797S-mediated resistance to first- or later-line osimertinib treatment in patients with non-small cell lung cancer (NSCLC). For more information, visit theseusrx.com or follow the company on LinkedIn.
Reporting to the President of R&D, the Vice President of Technical Operations is responsible for leading and directing the manufacturing strategy for the company. As a member of the leadership team, carries full budgetary responsibility for all process development and manufacturing operations including Product/Process Development, Manufacturing, and Supply Chain. The individual will be accountable for setting CMC strategy, selection, and management of CMOs, and representing all aspects of CMC on cross-functional project teams to ensure that products are manufactured in compliance with all applicable regulations.
- Provide functional and executive leadership of manufacturing strategy.
- Develop effective and efficient working relationships with both internal and external partners.
- Work closely with Regulatory to develop and implement CMC related Regulatory strategy.
- Ensure strategies in place to deliver for immediate and longer-term drug substance and drug product needs to meet clinical and preparedness for commercial needs.
- Oversee RFP processes to ensure timely selection of additional CMOs and initiation of process development activities.
- Work closely with external manufacturing partners to ensure reliable, compliant execution against production schedules to meet company and program goals.
- Develop, monitor, and report performance indicators to highlight progress, risks, and mitigation strategies.
- Hire, lead, and develop employees to successfully meet our objectives while balancing a highly externalized model.
- Develop and manage approaches to forecasting to ensure product supply on time and in location.
- Ensure performance of manufacturing sites in process validation and inspection readiness activities.
- Drive continued improvement and operational excellence at CMOs to maintain a high level of compliance and efficiency to world-class manufacturing standards all while minimizing waste.
- Communicate operational status regularly to senior management and program teams.
- Broad background in pharmaceutical operations encompassing aspects of CMC, quality, and supply chain; 15+ years of experience with an advanced degree required, PhD. in Chemistry preferred.
- Leadership experience across the continuum of pharmaceutical development to commercialization.
- Has contributed to the successful development, launch, and commercialization of a notable biopharmaceutical product, with a strong preference for small molecule experience.
- Experience managing a high-performance team in a science-driven and entrepreneurial environment.
- Excellent verbal and written communication skills including strong formal presentation skills and the ability to communicate complex scientific information in an organized manner.
- Driven, energetic, self-motivated, flexible, and hands-on – a “doer” and “builder”.
- Experience in both large and small company environments a plus.
- Well-developed internal partnering skills to interface and collaborate across multi-disciplinary teams.
- Results oriented with excellent analytical, strategic, business planning, communication, teamwork/collaboration and problem-solving skills.
- Confidence and credibility to partner with internal constituents and external colleagues effectively.
- Ability to influence across the company with exceptional interpersonal skills.