Associate Director, Programs Management
Associate Director, Programs Management
San Diego, CA
Samumed is a pharmaceutical platform company based in San Diego, California, focused on advancing regenerative medicine and oncology applications through research and innovation. Samumed has discovered new targets and biological processes in the Wnt pathway, allowing the company to develop small molecule drugs that have the potential to address numerous degenerative conditions as well as many forms of cancer. Samumed is currently conducting clinical trials for multiple disease areas, including oncology, osteoarthritis, Alzheimer’s disease, androgenetic alopecia, and idiopathic pulmonary fibrosis, and it has a broad pipeline targeting areas of significant unmet medical need.
Job Description and Responsibilities:
Samumed is looking to add a highly motivated Associate Director, Programs Management to its Clinical Development team. The Associate Director, Program Management will be responsible for planning, tracking, and driving timely execution of activities in support of IND- and NDA-track development projects. S/he will develop and manage the execution of high quality, integrated, cross-functional project plans. Samumed’s development teams are supported by matrixed resources and thus the position will require routine and open interaction with team leaders, team representatives, senior management, and function area leaders to build consensus on strategy and plans. This position will be based at Samumed’s San Diego headquarters.
The Associate Director, Programs Management will be responsible for the generation and maintenance of key project documentation for select assets in the portfolio. Documentation will include but not be limited to:
• Target Product Profile (TPP)
• Clinical Development Plan (CDP)
• Microsoft Project (MSP) Timelines describing ongoing and planned clinical development activities for each development project.
• Key project working assumptions and upcoming decision points.
• Phase-appropriate risk management process and documentation.
With Clinical Subteam Leader, the Associate Director, Programs Management will:
• Develop and oversee implementation of the clinical strategy and plan
• Facilitate strategic planning at the clinical subteam to ensure TPP and CDP requirements are fulfilled, and that any changes to the plan are effectively addressed and communicated
• Oversee progress and integrate information from clinical study teams, identifying cross-program clinical development issues that warrant strategic oversight
• Perform the day-to-day activities of project management, including conducting cross-functional team meetings, documentation of meetings, updating project plans, schedules and timelines, providing progress reports, and tracking progress vs. plan.
With Key Functional Leaders and/or Accountable Team Members, the Associate Director, Programs Management will:
• Identify and define project requirements, deliverables and related tasks, including interdependencies and deadlines. Includes key deliverables and activities in the MSP Timeline
• Identify upcoming decisions and facilitate information flow to enable timely and effective decision making for the project/program
• Identify key risks and facilitate the oversight and maintenance of project-specific risk management process
• Develop strategies to address risks and secure approval for mitigation and contingency plans, as appropriate
• Prepare materials for review and/or approval with executive leadership and other internal and external stakeholders as required
• Assign action items and follow up with staff to ensure timely completion
With the Head of Program Management, the Associate Director, Programs Management will:
• Develop and oversee implementation of the integrated strategy and plans to IND and NDA
• Provide input to the Project Management Office (PMO) in the development of standard practices and tools
• Set agenda, prepare materials and meeting records for the cross-functional development Team meeting.
• Advanced degree (MS or MBA) preferred. Candidates with additional relevant experience and a proven track record in successful clinical drug development will also be considered.
• Minimum of 8 years of drug development experience is required (pharma, biotech, CRO), preferably crossing more than 1 functional area.
• Minimum of 5 years of clinical project management experience and 2 years leading cross-functional, integrated clinical development teams.
• Prior experience in preparing and filing clinical regulatory documents (briefing documents for FDA meetings, IND and NDA and/or MAA) preferred.
• Proficient in MS Office software
• Excellent verbal and written communication skills