Overview of Position
Reporting to the CMO & R&D Operations/Portfolio Director, the Sr. Project Manager is responsible for project management support for multiple development functions at Taysha Gene Therapies. This role will work collaboratively with our cross-functional teams and participate in other key strategic business portfolio processes to ensure that all Taysha Gene Therapies development activities are conducted to the highest Good Clinical Practice (GCP) and quality standards, within agreed timelines and budgets.
The Sr. Project Manager will lead projects of varying scope and complexity which will include the implementation of process improvements, systems, corrective & preventative actions, and business efficiency efforts relevant to clinical development activities. This role will be highly cross-functional in nature but may also support department-level activities.
Essential Duties & Responsibilities
- Accountable to oversee and/or manage performance of CMO & R&D portfolio activities. This includes execution of activities in accordance with defined strategy, timelines and budget. Responsible to develop, maintain, track and report timelines for CMO & R&D deliverables
- Accountable to work with department heads and oversee CMO & R&D resource needs to support multiple development programs in accordance with strategy, timelines and budget; develop resource forecasting/management tools to identify risks and gaps to enable resource optimization
- Identification and hiring of appropriate PM function resources to support activities in accordance with outsourcing strategy, timelines and budget
- Liaise with department heads to develop, forecast and manage overall CMO & R&D budget
- Leads the team in defining and/or executing CMO & R&D portfolio strategies, developing goals, assigning project tasks and ensures the team meets all goals; provides clear direction on project requirements to meet expectations of stakeholders; provides PM technical expertise in all phases of project execution including tracking deliverables and reporting progress to senior leadership
- Provide leadership and decision-making support by establishing appropriate project governance & communications, managing risk, issues and changes and gaining the necessary stakeholder buy-in
- Lead and/or participate in system identification, improvements and optimization efforts or other efficiency initiatives
- Lead and/or assist in vendor identification through development and distribution of RFI/RFP and bid defense discussions in collaboration with cross-functional partners
- Lead initiation of role-based training matrix in consultation with department/function heads
- Leads internal department-level meeting activities including off-site and team building activities; issue high quality agendas and meeting minutes in a timely fashion
- Establish tracking/reporting of department-level activities, milestones, risks, etc. to senior leadership
- Lead development of department-level resources, tools, templates to optimize and standardize performance; define and execute organizational change and training initiatives and material, including department-onboarding and offboarding materials
- Lead department-level operational risk identification, management, and mitigation efforts and report progress to senior leadership
- Partner with appropriate functional areas to review and negotiate of scope of work and budgets; participate in the development/amendment of external vendor contracts related to department-level activities
- Respond to and participate in Quality Assurance audits and/or regulatory authority inspections
- Develop department-level guides for overall performance of regulated clinical trials including inspection readiness; responsible to oversee and manage regular quality checks including results reporting to senior leadership
- Sr. Manager may manage internal staffing and performance management, including training, coaching and performance reviews for project management staff. Mentors and develops staff.
- Contribute to the development and improvement of department-level and cross-functional Standard Operating Procedures (SOPs), processes, systems, tools
Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient. Excellent interpersonal skills, ability to develop important relationships with key stakeholders, ability to identify issues and raise to key stakeholders in order to develop relevant and realistic plans, programs and recommendations
- B.S./B.A. degree required, PMP certification desired
- 5+ years’ experience clinical research with demonstrated experience in clinical development/clinical operations (project/program management experience is required)
- Demonstrated excellence in project management and effective management of multiple projects/priorities
- Must have demonstrated ability to solve problems with innovative solutions along with strong organizational skills. Excellent written and verbal communication skills are required.
- Experience in gene therapy, rare/orphan disease highly desirable
- Experience managing clinical trials/projects, budgets, and timelines required
- Previous involvement in GCP regulatory inspections desired
- Excellent knowledge of ICH-GCP
- Ability and willingness to travel up to 15% of the time, as needed (domestic and international)
- Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor