
Partner Therapeutics
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Partner Therapeutics is committed to improving the lives of patients with cancer and other serious illnesses.
2 Jobs
LEUKINE Melanoma Program Team Leader – Executive Director
Partner TherapeuticsPartner Therapeutics is committed to improving the lives of patients with cancer and other serious illnesses.
• Owns full P&L including revenue, gross-to-net, operating expenses, and profitability with an initial focus on launch investment prioritization and management • Leads integrated launch planning across all elements of the supply chain, regulatory, development, medical affairs and commercial defining clear deliverables and accountability • Plans and executes on the most optimal launch that maximizes market uptake, patient adoption/convenience, guideline adoption as well as generation of value for PTx • Drives forecasting, scenario planning, and risk management • Authors key product development plans with clear goals, timelines, go/no-go decision points and target product profiles for clarity across the organization • Oversees execution of plan deliverables and implements subteams as needed • Chairs cross-functional melanoma program team and ensures alignment across functions and key interdependencies • Develops and executes communication plan (including publications, presentations, and press relations) • Ensures supply readiness and lifecycle supply reliability for melanoma launch • Defines approval strategy and labeling approach in US and ex-US as well as optimal launch sequence • Shapes integrated pre-launch strategy and launch strategy as well as tactics in partnership with all key stakeholders; ensures aligned prioritization of cross-functional tactics to realize plan, including launch sequence • Sets revenue targets and aligns incentives
External Quality Assurance IV
Partner TherapeuticsPartner Therapeutics is committed to improving the lives of patients with cancer and other serious illnesses.
• The QA Specialist IV External Quality Assurance (ExQA) role is responsible for the overall quality of biologic products and directly involved with CMO oversight of drug substance, sterile drug product and finished product manufacturing. • The individual is responsible for assuring compliance with current good manufacturing practices and regulatory compliance requirements and ensuring products, materials and services are procured, released and monitored via established systems. • Primary Quality point of contact for CMOs. • Ensures timely Quality review/approval of CMO deviations, change controls and batch release requirements and integrates these records into Partner Therapeutics’ (“PTx”) cGMP systems. • Ensures timely Quality review/approval of documents required to support technology transfer. • Responsible for the development, continuous improvement, coordination and ensuring compliance for all Quality aspects of the lifecycle stages of CMO Management. • Acts as a liaison between Quality Assurance, Regulatory, and our CMO partners in providing compliance oversight for regulatory submissions supporting technology transfer/existing CMO production, ensuring timely Quality review/approval of required regulatory documents. • Oversees change control implementations at CMOs, including timely Quality review/approval of documents and coordinating impact assessments from Subject Matter Experts. • Supports PTx Regulatory Intelligence role in the development and implementation of updates affecting CMO operations. • Supports PTx inspection readiness for CMO activities in alignment with good manufacturing practices, regulatory compliance requirements and current industry standards, including inspection walkthrough and preparedness activities, response management, and tracking. • Supports the other departmental responsibilities, including post market surveillance, product quality complaint investigations, and product labeling. • Supports/coordinates cGMP investigations for drug and finished product, CMO deviations, and integration into appropriate PTx Northpointe Quality Systems.