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Form of workZentalis Pharmaceuticals is a San Diego based pharmaceutical company dedicated to the discovery and development of small molecule therapeutics targeting fundamental biological pathways of cancer. Since our inception, we have successfully cleared four INDs with the FDA. We believe our deep pipeline of oncology therapeutics has the potential to significantly improve the lives of patients with various types of cancer.
JOB SUMMARY:
The Senior Director, CMC Program Management, partners with the Technical Operations Team Lead to create and successfully execute CMC development strategies. The role requires an in-depth understanding of pharmaceutical research and development processes and the interaction of TechOps deliverables with R&D strategies. The Senior Director is accountable for the cross-functional planning and execution of one or more programs, including definition of the operational strategy, management of timelines, cost, quality, and risk.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Create and maintain cross-function CMC plans, timelines, and budgets for each assigned program and ensure relevant stakeholders are informed of plans with appropriate line of sight.
- Partner with the TechOps Team Lead to manage a cross-functional matrix team of experts (Chemistry, Product Development, Analytical Development, Supply Chain, etc.) in advancing programs.
- Support and facilitate effective, science-based business decisions including development of scenarios as needed, highlighting interdependencies and downstream impacts (including but not limited to timelines and budget) of strategic decisions.
- Ensure all decisions are assessed and properly evaluated for various scenarios/options as well as risks and impacts.
- Proactively manage the identification and resolution of risks and issues across Functional reporting lines and Project team structure.
- Coordinate resource and budget planning across functions to assure adequate resources are applied to the project and any changes are highlighted appropriately.
- Support and foster a high performing team and monitor the health and operating efficiency of the team as a unit.
- Continuously improve the efficiency of the TechOps function by actively identifying areas that may need new processes and systems and incorporating them into a CMC Playbook.
- Provide infrastructure and operational support as needed to the Head of Program Management.
EDUCATION/KNOWLEDGE/SKILLS/ABILITIES REQUIRED:
- Minimum of 10 years of experience in biopharma industry, including at least 6 years in CMC project management.
- Advanced degree (e.g., PhD) in Life Sciences, Chemical Sciences, Physical Sciences or other relevant discipline highly preferred.
- Leadership skills including situational leadership, ability to lead a team of experts and influence without authority.
- Demonstrated ability to lead matrix teams, knows how to work at the strategic level and when to delve deeper to resolve issues and challenges.
- Strong communicator able to integrate and succinctly summarize the various parts of a project and effectively tailor messages to audience incl. senior leaders.
- Development of high-quality documents and presentations for review at governance committees and support senior management in preparation of documents and presentations as needed.
- Demonstrated ability to lead multiple programs and initiatives and to prioritize tasks.
- Demonstrated ability to work the vendors and contractors (e.g. experience working with CDMOs).
- Experience setting and tracking cross-functional program budgets.
- Experience with Microsoft Project.
- Excellent Project Management Skills - drives execution while balancing speed, quality, and cost.
- Successful line management experience.
