Job Title: Director, Project Management Lead

Location: Menlo Park, CA, US

​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. To identify and control promising product candidates based on exceptional scientific development and administrational expertise, develop our products in a rapid, cost-efficient manner and to pursue commercialization and/or development partners when and where appropriate.

We will accomplish this by building a team of world class scientists and business administrators that apply themselves to this mission. Team Summit exists to strategize and execute a path forward in medicinal therapeutic health care that places us in a top market share leadership position. Team Summit assumes responsibility for stimulating continuous expansion of knowledge, ability, capability and wealth for all involved stakeholders.

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Overview of Role:

The Project Management Lead, Director level reports into the VP, Program Management and part of the larger Stakeholder Relations & Corporate Strategy Department. The Project Management Lead will be an essential part of the cross-functional oncology program management team to maximize the value of Summit’s pipeline drug candidates, with an immediate focus on ivonescimab (PD-1/VEGF Bispecific Antibody, SMT112) and contribute to the execution of the development plans, from multiple clinical trials (including Phase III trials) to BLA / MAA / other regulatory approval filings and commercialization. Previous experience as a Project Management Lead (PML), Product Team Leader (PTL) or similar roles in late-stage oncology drug development through commercialization experience will be most successful and prepared to thrive in this exciting role.

The Project Management Lead is primarily accountable for developing and maintaining an integrated product plan and project plans to cover all aspects of the clinical operations, clinical development program, regional regulatory submissions and commercialization or lifecycle activities for SMT112. The Project Management Lead will be a key contributor as well as facilitator to creative, strategic approaches to development to commercialization, plus securing appropriate resources to drive results. Core Team management and the ability to grow with the organization is essential.

The Project Management Lead role is a strategic and execution role that requires proactivity, collaboration, and an emphasis on partnership with the cross-functional team as well as other stakeholders and collaborators, both within and outside the organization. The Project Management Lead has negotiation and persuasion skills necessary to ensure success of the program and progress towards goals for the development of Summit’s lead asset, SMT112, and specific program-related goals.

Role and Responsibilities:

• Manage the integrated SMT112 product plan through effective leadership and representation from cross-functional partners, to execute a development plan that provides a thorough and clear strategy for maximizing the asset’s chances of development and regulatory success
• The lead and owner of project management activities, timelines creation and management, along with documenting all key decisions
• Actively contribute as well as leadership to build the organization’s project management capabilities, platform, tools and templates tailored to an innovative drug developer
• Creating, reporting and presenting program information to functional heads and other key stakeholders all the way to Executive Committee members
• Driving decision-making for development and global commercialization SMT112, leading to its marketing approval while ensuring relevant research, analysis, competitive data, and expertise are taken into account
• Partnering with cross-functional representatives and external partners / alliances to ensure that all issues and questions are being addressed, and that functional area input into the strategy is adequate to meet the objectives of the molecule
• Execution of internal / external development and proactively identifying issues and risk management while contributing to contingency planning and problem solving
• Facilitating development and implementation of optimal clinical operations, clinical development, and regulatory strategies to protect and maximize asset value
• Ensuring adequate project resource utilization and budget management, providing clarity and transparency on changes and potential tradeoffs
• Ensuring team alignment with the functional heads and executing on feedback regarding Go / No-Go decisions, timelines, key activities, resource allocations and budgets, valuations, and prioritization

Capabilities:

• Understand solid tumor oncology science and ideally lung cancer, plus experience in current and innovative therapeutic biopharma oncology development and regulatory process
• Ability to identify and collaborate with stakeholders, including at the most senior levels in the organization for drug development, manufacturing and commercialization
• Demonstrated ability to effectively prioritize, multitask, and execute tasks in a fast-paced environment is crucial
• Ability to integrate all cross-functional disciplines into a successful strategy and to drive results
• Strong problem-solving skills for developing creative solutions and meeting project objectives
• Demonstrated ability of strategic thinking and contingency planning, notably in drug lifecycle activities, indications expansion and global regulatory processes

Experience, Education and Specialized Knowledge and Skills:

• Bachelor’s Degree (scientific or healthcare discipline preferred) with 10+ years of pharmaceutical / biotech industry experience in a project management role
• Project Management Professional (PMP) certification or similar project management experience in oncology drug development leading core teams or product sub-teams preferred
• Prior biopharma oncology Project Management Lead (PML) or Product Team Lead (PTL) experience strongly preferred
• Experience in late-stage drug development and registrational trials preferred
• Experience in cross-functional team leadership, including strategy development and driving tactical delivery of program with core teams and sub-team matrix model
• Collaboration experience or strong experience working with alliance management and external partners (e.g., co-development, academic centers, international cooperative groups) is preferred

​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.

Job Type: Full-time

Pay: $130,000.00 - $200,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off

Compensation package:

• Stock options
• Yearly bonus
• Yearly pay

Experience level:

• 7 years

Schedule:

• 8 hour shift

Ability to commute/relocate:

• Menlo Park, CA 94025: Reliably commute or planning to relocate before starting work (Required)

Work Location: In person

Speak with the employer
+91 6507039639

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