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Director, CMC/Supply Project Management

4 months ago

Doral, United States Summit Therapeutics Sub, Inc. Full time

Job Description

Job Description

Our Mission: To build a viable long-lasting health care organization that assumes full responsibility for designing, developing, trial enrollment, regulatory approval and commercializing patient, physician, caregiver, payor, and societal friendly medicinal therapy intended to improve quality of life, increase potential duration of life and resolve serious medical healthcare needs. We will accomplish this by building a team of world class scientists and business administrators that apply themselves to this mission. We have in-licensed Ivonescimab (PD-1/VEGF Bispecific Antibody, SMT112), which is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. We have initiated phase-III clinical studies in the following NSCLC indications: Ivonescimab combined with chemotherapy in patients with epidermal growth factor receptor (EGFR)-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a third-generation EGFR tyrosine kinase inhibitor (TKI) (“HARMONi”) Ivonescimab combined with chemotherapy in first-line metastatic squamous NSCLC patients (“HARMONi-3”)

Ability to travel to Summit Offices in CA, FL, UK or other locations for business up to twice per month. Preferred location is UK or Miami with Remote East Coast US location may be considered for qualified candidates.

Overview of Role: The Director, Project Management, will lead the cross-functional project management activities that directly deliver CMC, Supply and Quality functional success and to ensure overall readiness for commercialization. This role requires a proactive persistence, charismatic and hands-on project manager who is comfortable working across US, EU and China time-zones and with diverse stakeholders. This is a proven PM who has demonstrated repeated successes bringing drugs to market through the CMC/Supply function, navigates around or over challenges with urgency, positive and assertive communicator, solutions-oriented approach and can build product relationships quickly. Role encompasses: facilitating complex cross-functional meetings, building detailed project plans that operationalize strategy, assigning tasks, communicating constructive feedback and driving execution respectfully across the company and with partners.

Role and Responsibilities: Deliver high-quality and proactive project management to a cross-functional team: CMC, Supply, Quality Manage delivery of assigned cross-functional projects and build the mission-critical activities with stakeholders to prepare Summit Therapeutics for successful commercialization readiness Build and establish complex project timelines, status updates and the go-to for the supported team or senior leadership, this is a high-visibility position Ensure key project milestones roll-up to program-level that contributes to effective Program Management and part of an overarching program plan document, including an integrated CMC/Supply launch readiness plan Actively contribute to the goal to build scalable program capabilities tailored to an innovative oncology company across our licensed territories Create and maintain status reports, visualizations, assessments for decision-making and presentation materials for routine cross-functional or team leader meetings Objective voice, teamwork and clarity on projects to ensure decision quality and sense of urgency Proactively identifying issues, opportunities to pursue and risk management while contributing to contingency planning and problem-solving Ensuring adequate project resource utilization and budget management, providing clarity and transparency on changes and potential tradeoffs

Capabilities: Understand solid tumor oncology science and ideally lung cancer, plus experience in current and innovative therapeutic biopharma drug development and processes Ability to identify, collaborate and facilitate with stakeholders, including senior levels in the organization for drug development, manufacturing and commercialization activities Demonstrated program and/or project management competencies to effectively prioritize, multitask, and execute tasks in a dynamic environment—specific to CMC, Supply and Quality Ability to integrate all cross-functional perspectives on a project into a successful approach to drive results, managing and/or leading dynamically to meet company goals Demonstrated ability to execute company and product strategy, yet adaptable to evolving factors and can contribute to improving strategy and scenario planning within assigned departments

Experience, Education and Specialized Knowledge and Skills: 15 years of prior

pharmaceutical/biotech

experience in similar PM roles required Rigorous understanding of IV oncology drug development and manufacturing for clinical and commercial supply chain is required Experience from pharmaceutical roles managing diverse projects, levels of complexity and in a global environment; for example, CMC project manager, FDA inspection readiness project manager, drug supply project manager, CMC/Quality consultant Bachelor’s Degree (scientific or healthcare discipline preferred) with at least 12 years of pharmaceutical / biotech industry experience in a project management role is preferred Culturally competent to communicate and effectively navigate cross-culture needs with partners is preferred Project Management Professional (PMP) certification or similar project management experience is preferred Prior solid tumor oncology disease/drug experience strongly preferred Collaboration experience working with alliance management and external partners (e.g., co-development, global supply chain) is preferred Specialized consulting in drug development CMC/Quality and contributing to strategy-building is desirable Experience contributing to BLA preparation, CMC/Quality inspection readiness, assessing risks with leading the development of mitigations and execution is desirable Prior solid tumor oncology disease/drug experience in late-stage drug development and understands registrational trials is strongly preferred Collaboration experience working with alliance management and external partners (e.g., co-development, academic centers, international cooperative groups) is preferred Proficient user of MS Office suite (e.g., Project, PowerPoint, Word, Excel), experience using electronic document management systems, document review tools and expertise in standard project management software required Strong computer skills, organizational skills and multi-task management Excellent communicator in public-speaking, meeting facilitation, email communication and in-person Ability to excel in a fast-paced, demanding, culturally diverse and collaborative environment The pay range for this role is $135,000 to $194,000 annually. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation. The successful candidate will also be eligible for health benefits, 401(k) with 6% employer match from day one, ESPP with a 15% discount up to the federal limit, flexible spending account among other benefits compensation. Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment

businesses/agencies

are required to contact Summit’s human resources department to obtain prior written authorization before referring any candidates to Summit.

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