Our Mission

To build a viable, long-lasting health care organization that assumes full responsibility for designing, developing, trial execution and enrollment, regulatory submission and approval, as well as successful commercialization of patient, physician, caregiver, and societal-friendly medicinal therapy intended to: improve quality of life, increase potential duration of life, and resolve serious medical healthcare needs.

Limited travel may be required depending on assigned activities or projects

Overview Of Role

The Senior Manager, Project Management, is an essential part of the ivonescimab program team who be assigned to a clinical-stage oncology study to ensure effective project start-up and management. You will engage early with strategy and planning stakeholders and also directly with clinical operations, clinical development, regulatory, biometrics, supply and key members of a study management team. The ability to take on additional responsibilities and grow with the company is essential. A successful project manager brings prior solid tumor oncology pharma experience, a strategic mindset to ensure R&D-Business Strategy is implemented, works well across internal and external stakeholders, plus has core operational capabilities to ensure project delivery. This project manager will need an assertive management approach, objective and respectful communication style, proactive planning skills, and takes action. Role reports direct to the Head of Product Strategy & Program Management.

Role And Responsibilities

Cross-functional Leadership
- Deliver high-quality plans and proactive project management to a clinical study team and functions
- Be a rationale management voice, the person who asks the hard questions and thoughtful facilitator to meetings
- Lead key activities or assigned projects, which will go beyond initial study responsibilities
Drug Development Oversight
- Provide strategic program input and operational planning considerations to the study team lead or key functional members to optimize success of the study
- Courage to execute, creativity to bring new solutions to challenges and flexibility to change course
- Connect the team and functions, communicating across channels to keep projects and teams on-track
Risk Mitigation
- Maintain decision-quality approaches within assigned areas, options and trade-offs assessments
- Actively identify, track and mitigate risks, to include opportunity creation that may accelerate project success
Resource and Timeline Management
- Establish and maintain detailed timelines, lead activities tracking and deliver frequent reporting
- Problem-solve resourcing needs, understand budgets and workload planning
Portfolio Management
- Manage complex activities or projects that cut across departments or with a CRO, building the bridges or addressing gaps seamlessly
- Be a steward of the Program end-to-end, development to commercialization, may require leading and managing beyond role

Capabilities

Know oncology, late-stage clinical studies, drug development and regulatory processes
Ability to quickly build strong and sustaining relationships with stakeholders, including senior levels in the organization for drug development, manufacturing and external partners activities
Demonstrated program and/or project management competencies to effectively prioritize, multitask, and execute tasks in a dynamic, collaborative environment where focus and flexibility are essential
Ability to integrate all cross-functional perspectives across a study team, CRO and vendors on a clinical study/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, adaptable to evolving factors and can contribute to improving strategy and scenario planning

Experience, Education And Specialized Knowledge And Skills

Prior pharmaceutical (drug development) experience required
Previous experience as a pharmaceutical project manager, late-stage clinical study project manager, or CRO study project manager will offer the best opportunity for readiness in this position and is strongly preferred
Bachelor’s Degree (scientific or healthcare discipline preferred) with at least 5 years of pharmaceutical / biotech industry experience in a project management role is preferred
Project Management Professional (PMP) certification or similar project management experience is required
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., PowerPoint, Word, Excel, Project), experience using electronic document management systems, document review tools and expertise in standard project management software (Smartsheets) 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 $149,657 to $177,727 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.

Summit Therapeutics, Inc. jobs

Senior Manager, Project Management