Coherus Oncology · 1 week ago
Director, CMC and Life Cycle Management (LCM) Lead
Redwood City, CA
Full-time
Onsite
Director/Executive
$190K/yr - $240K/yr
8+ years expCoherus Oncology is a company focused on developing innovative therapies for cancer treatment, and they are seeking a Director, CMC and Life Cycle Management (LCM) Lead. This role involves creating and driving programs from development to commercial launch, collaborating with CMC leadership and cross-functional teams, and leading Life Cycle Management activities post-launch.
BiotechnologyHealth CareMedicalOncologyTherapeutics
Responsibilities
Lead and facilitate CMC and LCM cross-functional teams, including scheduling, developing agendas, writing and distributing meeting minutes, and tracking decisions and action items
Partner with cross-functional leadership to establish comprehensive, functionally integrated, end-to-end CMC timelines that are aligned with overall program timelines and strategy
In collaboration with internal project teams and external vendors
Implement project plans
Identify and manage critical path activities and their interdependencies
Identify and proactively mitigate roadblocks
Identify and communicate risks and key mitigations
Capture and communicate progress to senior leadership; escalate potential delays with proposed solutions
Develop and manage program budgets, including purchase orders and SOWs
Responsible for all project team documentation, including agendas, minutes, actions, decisions, timelines, scorecards, goals, and dashboards
Facilitate internal project team meetings and weekly working team calls with vendors
Present project updates, issues, path forward options, and recommendations to program team and functional Senior Management in timely fashion
Collaborate with personnel across Coherus to ensure alignment around key business objectives
Ensure that projects adhere to agreed-upon scope, timelines, resources, and budget; resolve or communicate departures
Qualification
Required
B.S. or B.E. in chemical engineering, bioengineering or related field
8+ years of Pharmaceutical/ Biotech industry experience in technical operations
Strong technical understanding of CMC development from early to late stage, validation, and commercialization requirements
Working knowledge of GMP regulations, PPQ expectations, and regulatory filing timelines (IND, BLA/NDA, supplements)
5+ years of Project Management experience and knowledge of project management methodologies, concepts and techniques is required
Ability to manage complex, cross-functional projects with internal and external stakeholders
Excellent written, communication and organizational skills
Expertise using Project Management software to build timelines and manage resources, risks, and costs
Rapidly integrate new information into existing plans
Work well under tight deadlines, with the ability to prioritize workload against deadlines and corporate objectives
Work well in cross-functional teams and be able to communicate effectively with external partners, peers, and senior management
Strong negotiating and interpersonal skills, and the ability to clearly present recommendations
Possess excellent decision-making, leadership, interpersonal, verbal and written communication skills
Preferred
A postgraduate degree (e.g. MS, PhD) is a plus
Experience in managing late-stage commercial products is a plus
Project Management certificate is a plus
Prior experience working in a fast-paced, entrepreneurial, development-stage company
Prior experience managing third-party relationships
Company
Coherus Oncology
Coherus Oncology is a fully integrated commercial-stage innovative oncology company with an approved next-generation PD-1 inhibitor, LOQTORZI, and a promising pipeline that includes two mid-stage clinical candidates targeting liver, lung, head & neck, and other cancers.
201-500 employees
Funding
Current Stage
Public CompanyTotal Funding
$1.27BKey Investors
Pharmakon AdvisorsNorthern Star PartnersShanghai Junshi Biosciences
2023-05-15Post Ipo Equity· $50M
2022-01-07Post Ipo Debt· $100M
2022-01-01Post Ipo Debt· $400M
Leadership Team
Dennis Lanfear
Founder, President, and Chief Executive Officer
Richard Hameister
Chief Technical Officer
Recent News
2026-01-06
2026-01-05
Company data provided by crunchbase