Director, Project Management, Clinical
Tricida, Inc. is a privately-held, clinical stage, biopharmaceutical company focused on the discovery and development of non-absorbed therapies. Tricida’s lead investigational drug candidate, TRC101, represents a first-in-class approach to the treatment of metabolic acidosis, a common complication of chronic kidney disease (CKD) that can result in increased mortality, accelerated progression of kidney disease, progressive muscle breakdown and exacerbation of bone disease. Tricida is led by a management team with an accomplished and proven track record in discovering and developing new therapeutics, with extensive experience in building successful companies around strong science and unmet medical needs. The Company is backed by world-class venture capital firms. We are expanding our existing group of exceptionally talented and motivated professionals to bring new drug candidates into clinical development.
We seek a Director, Project Management, Clinical, skilled in pharmaceutical drug development to lead project management of Tricida’s clinical activities in conjunction with internal subject matter experts, consultants and external vendors. This position requires the ability to integrate efforts and activities in clinical, regulatory and CMC in seamless interactions with cross-functional teams, using excellent communication and providing clear direction for objectives, milestones and timelines. This position will be responsible for planning and on-time completion of a variety of activities including the management of deliverables, adherence to budget, and ongoing risk mitigation to meet regulatory timelines and to initiate and complete clinical studies. The Director Project Management, Clinical will report to the VP Project Management. The successful candidate must possess a strong technical understanding of the inter-disciplinary nature of drug development, preferably demonstrated with previous clinical and drug development experience.
- Provide project coordination and communication in support of writing, review, publication and timely filing of clinical related regulatory and study site documents, including those associated with INDs, CTAs, IMPDs, and NDAs.
- Provide clinical project coordination and communication, including facilitation of the negotiation and management of contracts and deliverables, participation in update calls and face-to-face meetings, development of agendas, tracking of action items, and scheduling of follow-up meetings with certain vendors.
- Assist with preparation for interactions with FDA including clinical site inspections and possible FDA GCP inspections.
- Facilitate cross-functional planning of clinical activities across departments and disciplines to align dependencies, schedules, budgets and delivery commitments.
- Use solid understanding of business and scientific principles to help establish priorities and proactively identify potential risks, resource constraints, and conflicts that could impact project timelines; collaborate with the development team to develop appropriate solutions.
- Provide strategic evaluation/analysis of work flow processes with strong planning and adaptation as necessary to support on time project completion.
- Assist with scheduling of clinical project team meetings and assist with stakeholder communication, as necessary.
- Assist in preparing presentations, including project plans, etc.
- Perform additional responsibilities as deemed necessary by management.
Experience & Skills:
- B.S. in a pharmaceutical discipline, with advanced degree a strong plus.
- Minimum of 10+ years of direct pharmaceutical project management experience supporting drug development teams with direct involvement in the clinical area. This includes experience with management of CROs and external vendors.
- Demonstrated success in managing schedule, resources and budgets for pharmaceutical development programs.
- Strong understanding of the regulatory requirements for all phases of pharmaceutical drug development for programs with multiple global studies, including Good Clinical Practices (GCP).
- Detail-oriented and strong ability to critically evaluate and troubleshoot complex problems and unexpected challenges, while offering timely and informed options for resolution.
- Outstanding leadership, communication and interpersonal skills; capable of negotiating and communicating relevant information across all levels of the company, with the ability to effectively influence different functional groups at all levels of management in global and virtual environments.
- Must thrive in a fast-paced, changing, dynamic and intense startup-like environment and be able to effectively collaborate in a cross-functional environment.
- Demonstrated ability to exercise independent judgment and strategic thinking with minimal supervision.
- Experience in tracking large-scale and long-term project and budget plans is highly preferred.
- Advanced Microsoft Project, PowerPoint, Excel, SharePoint skills are essential.
- PMPP certification is a plus.
- Ability to travel up to 10%, domestic and international.
Competitive Compensation and Benefits include: Medical, Dental, and Vision Coverages, Life, AD&D, Disability, 401(k), Flexible Spending Plan, and Pre-IPO stock options. 15 vacation days per year and 11 paid holidays per year, which includes 1 floating holiday.
Tricida is located in South San Francisco, CA.
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