Clinical Director Of Program Management

Associate Director / Director, Clinical Program Management

Remote, USA

Requirements:

• Must have either Oncology and/or Immunology experience
• Must have biotech/pharma experience working with internal clinical development teams (ie scientists) on compound development
• Note that this position is NOT someone on the ClinOps side who who only has experience with clinical trials
• Experience working with compound development teams - knowledge of drug development process
• Big pharma experience (AbbVie, BMS, Pfizer, J&J, etc) is a plus
• PhD in life sciences ideal - preferred but not required

Vividion is a next generation biotechnology company based in San Diego that is leveraging its proprietary chemical proteomics platform to conduct proteome-wide footprinting of drug-protein interactions with unprecedented breadth and precision. Our technology allows us to screen, identify and optimize novel drugs that selectively bind virtually any protein, including proteins previously considered “undruggable”. Our pipeline and emerging programs reflect a matured and productive platform capable of delivering first in class drugs utilizing novel mechanisms of action (allosteric inhibitors, protein-protein interaction inhibitors, functional activators, degraders etc.) against undruggable targets in the oncology and immunology space.

We prize scientific excellence, creativity, team players and we are committed to continued innovation. We have worked hard to create a collaborative and dynamic work culture where your ideas and discoveries are valued and will have an impact. We are growing and there are opportunities for mentorship and career progression.

Vividion was ranked #2 mid-size company on The San Diego Union-Tribune's 2022 Top Workplaces list.

Job Summary:

The Associate Director / Director, Clinical Program Management will provide comprehensive support to the Clinical Development Team in planning and achieving corporate development objectives. This position holds significant responsibility in assisting the clinical development team throughout the entire process, starting from Phase 1 clinical trials and extending to regulatory filings.

Essential Duties and Responsibilities:

• Support Compound Development Team Leader to provide PM end support, including to communicate key compound risks, and working with team to mitigate risk factors.
• Support and collaborate with other cross-functional teams as needed.
• Serve as primary PM for the Clinical Development team, including development and maintenance of strategic plans, timelines, and budgets.
• Drive cross functional communication and decision making to ensure alignment with internal and external stakeholders.
• Develop and administer project status tools (e.g., dashboards, reports, templates, business processes) to assess project team performance.
• Lead project and program meetings, study meetings, and clinical team meetings: develop meeting agendas, prioritize topics, summarize decisions, and action items.
• Oversee external vendor activities including adherence to timelines, contracts, and budgets, along with invoicing process.
• Work closely with Finance to generate budget forecasts in alignment with Clinical Development Plan.

Educational and Experience Requirements:

• Effective troubleshooting and problem-solving skills
• Experience with Project Management Software (SmartSheet, MS Project, ThinkCell, and OfficeTimeline)
• Knowledge of the drug development process
• Familiarity with FDA and/or EMA Regulations, ICH Guidelines, and GCP governing clinical development activities.
• Be an effective team player and strong individual contributor, flexible, and able to handle multiple tasks and deliver high-quality results under tight timelines
• Phase 1/2 Clinical study experience highly preferred
• BA/BS in a scientific field plus 8-10 years of pharmaceutical/clinical development experience, including a minimum of 5-6 years project/program management experience
• Expertise in a functional area directly contributing to successful mid to late-stage drug development
• Excellent oral and written communication skills
• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, SharePoint)

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