Director/Sr. Director, Product Development - Immuno-Oncology

Title:                                     Director/Sr. Director, Product Development - Immuno-Oncology
Reports To:                         Vice President, Product Development
Location:                             Redwood City, CA
Classification:                    Exempt
 

Position Overview

The Director / Sr. Director of Product Development - Immuno-Oncology is responsible for leading all cross-functional activities required to advance a program through non-clinical, clinical, and technical development; regulatory submission; and manufacturing. The Director / Sr. Director of Product Development serves to integrate cross-functional input, synthesize team recommendations, and direct the program through corporate governance, while maintaining adherence to timelines and budget.  Lastly, the Director / Sr. Director of Product Development is expected to maintain consistent, multi-level communication with Development Team Members, Senior Management, and the Executive Team, including the CEO.

Specific Responsibilities

• Partner with cross-functional leaders to develop comprehensive product development and lifecycle management plans (Non-Clinical, Clinical, CMC, Regulatory) that optimize: value, time, resources, risk, and alignment with business objectives
• In collaboration with cross-functional team:
• Implement product development and lifecycle management plans
• Identify and manage critical path activities and resources
• Identify and manage interdependencies and hand-offs
• Identify and proactively mitigate roadblocks
• Identify and document risks, likelihoods, severities, and key mitigations
• Lead contingency planning
• Capture and communicate progress; escalate potential delays with proposed solutions
• Direct programs through corporate governance to ensure that:
• Projects have adequate resources and technical expertise to meet strategic objectives
• Issues are raised, discussed, and resolved in a timely manner
• Project teams receive management decisions in a timely manner
• Programs adhere to agreed-upon scope, timelines, resources, and budget
• Communication
• Responsible for all project team documentation: agendas, minutes, timelines, development plan, discussion aids, risk logs, and decision logs
• Responsible for facilitating Product Development Team (“Core Team”) and CMC Sub-Team Meetings
• Present project updates, strategic issues, options, and recommendations to Strategy Team, Steering Committee, and Executive Team, including the CEO

• The Director/Senior Director, Product Development must have the ability to drive the development of drug candidates into therapeutics that can be filed, approved by regulatory agencies, manufactured, and successfully commercialized.

Education and Background

• BS/BA degree in a scientific, medical or business discipline. A postgraduate qualification (e.g., Ph.D., MBA, MS) will be a distinct advantage
• Knowledge of project management methodologies, concepts and techniques is required (PMP Certificate a plus)
• A minimum of 10+ years of biopharmaceutical industry experience, 5+ in a Project Management function
• Experience leading and managing Oncology/ Immuno-Oncology Programs is a plus
• Proven ability to manage complex, cross-functional development projects with multiple scenarios
• Expertise using Project Management software to manage timelines, resources, risks, and costs
• Ability to rapidly integrate new information into existing plans
• Ability to influence across all levels of the organization
• In-depth knowledge of global, late-stage, biologic drug development, including:
• Clinical Study Reports
• Drug Substance Process Validation
• Drug Product Process Validation
• FDA / EMA Interactions: Briefing Documents, Meeting Preparations
• CTD structure and contents
• BLA / MAA writing, review and filing
• Prior experience working in a fast-paced, entrepreneurial, growing company
• Ability to achieve business results with colleagues of diverse levels, functional expertise, skills, and priorities: effective as both a team player and a team leader
• Ability to maintain a clear focus on business objectives
• Take a hands-on, “roll up your sleeves” approach
• Drive, facilitate, track, anticipate, influence, and implement team objectives
• Challenge the status quo where relevant
• Resolve conflicts within the team
• Think strategically and solution oriented
• Outstanding communication, presentation, written and organizational skills

Beginning July 19, 2021, Coherus BioSciences requires all new hires to be fully vaccinated against COVID-19 as of their start date.  This requirement is a condition of employment at Coherus BioSciences, and it applies regardless of whether the position is located at a Coherus BioSciences facility or is fully remote.  If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.