The Pharmaceutical Development department at Calithera Biosciences is seeking a highly motivated individual to manage multiple projects within the constraints of scope, quality, time and cost, to deliver specified requirements. The position will manage the initiation, planning, execution, control and close out of cross-functional projects and ensure integration, coordination, timing and consistency of processes throughout multiple projects, as well as manage the integration between CMC (manufacturing and supply chain logistics), clinical (trial preparation and execution) and preclinical (IND-enabling and supporting activities).
Calithera is focused on discovering and developing small molecule drugs that slow tumor growth through controlling key metabolic pathways in the tumor and immune cells.
Tumor metabolism and tumor immunology are promising new interrelated fields for cancer drug discovery. Recent clinical successes have demonstrated the potential to slow abnormal cell growth and create fundamentally new therapies for cancer patients. Our investigational onco-metabolism medicines take advantage of the specific metabolic requirements of tumor cells and cancer-fighting immune cells.
Calithera’s discovery and development efforts are focused on diseases for which new treatments are urgently needed for patients suffering from renal cell carcinoma, triple negative breast cancer and other tumor types.
Duties and Responsibilities
- Assemble comprehensive Gantt charts including specific resource allocation (person(s) responsible) for all preclinical- and clinical-stage programs integrating cross-functional activities to validate the project plans.
- Take a lead role in the development of a comprehensive Product Development Plan to support NDA filing and launch of a clinical program
- Provide and manage regular program-wide dashboards for each development program to Senior Management team.
- Review Gantt charts (or derivative PowerPoint charts) with team members on a regular basis to update, provide reminders, identify critical path items, develop action plans to solve critical issues, and elevate specific concerns to senior management.
- Guide and support team leaders in prioritizing, trouble-shooting and contingency planning.
- Evaluate timeline project overlap by providing cross-functional, cross-project Gantt analysis.
- Identify program-related risks and work with teams to develop mitigation plans.
- Manage program-wide communication of critical issues; provide formal and informal briefings on project status to team members, functional heads and senior management.
- Support the management of logistics in clinical operations activities by assembly and regular review of timelines for recruitment, drug pharmacokinetic and biomarker CRO activities, and study activation, conduct, and closeout.
- Work with clinical teams, CMC sub teams and other contributors to identify critical issues, critical path, and project overlap.
- Working with Project Leaders, manage the preparation of program-wide development plans including full nonclinical, manufacturing, clinical development, regulatory, and quality management directed toward regulatory approval.
- Attend and record all project team meetings including critical issues, actions and responsibilities.
- Work with the team to develop project-related budgets.
- Manage all operational aspects of corporate partnerships.
Qualifications and Requirements:
- BS or equivalent with at least 10 years experience in project management roles.
- Prior supervisory experience.
- Thorough knowledge of the role and function of project management in high-performing team environment.
- Direct experience with project management related to NDA filing is a strong plus.
- Local candidates strongly preferred.
Calithera Biosciences, Inc. is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.
Interested candidates should submit their resume to email@example.com