Senior Director, Technical Product Strategy Team Leader - Small Molecule (Remote)
Full Time
Remote
Posted
Job description
Summary
The Product Strategy Team (PST) is a cross-functional leadership team at Arcus Biosciences accountable for successful accomplishment of integrated product development activities for an asset from Drug Candidate (DC) selection to commercial approval and lifecycle management. PST responsibilities include ensuring deliverables in alignment with the Integrated Product Plan (IPP), asset-level budget oversight, risk tracking and mitigation, asset-specific components of regulatory filings, coordination, and oversight of CMC activities to support development and commercialization, partnership/alliance oversight, etc. The PST is co-lead by a clinical lead and a technical lead.
The Technical Product Strategy Team Leader will partner with the Clinical Product Strategy Team Leader to co-lead and oversee the PST deliverables. In addition, this individual will also be responsible for CMC-specific deliverables for the asset by collaborating with internal cross-functional partners in Quality, Regulatory, Clinical Development, and Commercial along with our CDMO and external partners. This individual will report to the Senior Vice President of Pharmaceutical Development and Manufacturing and will be a key member of the leadership team responsible for ensuring that all CMC deliverables are met in a timely manner per commitment.
Responsibilit
ies
- Lead the PST by setting strategies and objectives and provide oversight of PST execution in alignment with product goals and objectives
- Provide strategic context for objectives and decisions to team, senior leadership, and the broader organization as appropriate
- Responsible for communication between PST and senior management/governing bodies including periodic updates/product reviews and recommendations for decision making
- Identify resource requirements to ensure successful delivery of product objectives.
- Identify and resolve issues within scope of the PST
- Identify key functions necessary to enable effective decision-making are present
- Ensure required discussions occur either at the team meeting or, as needed, in sub-groups/committees for further elaboration and evaluation.
- Support the development and execution of integrated cross-functional CMC project plans with established goals, milestones, timelines, and budget to enable program analysis and planning
- Ensure integrated project plans are consistent with CDMO timelines/deliverables for execution and partners for strategic alignment
- Coordinate various joint CMC steering committees with CDMO and partners to ensure that strategic goals, project deliverables, and key metrics are tracked and in a state of control
Qualifications
- M.S. or Ph.D. degree in Chemistry, Organic Chemistry, Analytical Chemistry, or related field
- 12+ years of experience in the biotechnology/ pharmaceutical industry including leadership roles (e.g., team leadership or functional leadership roles) in key CMC functions (e.g., Process Development, Manufacturing, Quality)
- Drug development knowledge with basic to strong understanding of functions relevant to the position including Research, Preclinical, Clinical, Commercial and Regulatory with demonstrated experiences in CMC commercialization
- Proficient with pharmaceutical product commercialization and life cycle management; ability to recognize strategic implications of complex product development activities and manage them cross-functionally
- Proven track record in project management for small molecule programs through late-stage development, especially process characterization, tech transfer, process validation, and lifecycle management in support of product licensure and commercialization
- Advanced project management skills, including the ability to identify and execute strategic initiatives, manage multiple projects, prioritize project resources, and assess project effectiveness and efficiency.
- Experience in managing development and manufacturing activities at CROs and CDMOs
- Authoritative command of dealing with complexity and ambiguity; ability to collect, digest and communicate information through relevant business analyses to influence decision-making
- Ability to communicate vertically and horizontally through multiple channels, leverage contact network to motivate diverse teams, and enable cross-functional collaboration
- Ability to work independently, be self-motivated, and be able to work as collaboratively a team member in a fast-paced, matrix environment
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3928 Point Eden Way I Hayward, CA 94545 – Arcus Biosciences is an equal opportunity employer
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