Director Process & Standards, Translational Medicine, Clinical Research

Job Description

The Translational Medicine (TMed) Clinical US Operations Director of Process and Standards will be responsible for ensuring that standard operating procedures (SOPs) and associated documents and systems related to Global Clinical Development are efficient, compliant with current requirements, and most importantly, aligned with the needs of TMed Clinical to ensure we can deliver on the pipeline with quality, precision, and efficiency. This individual will coordinate and oversee TMed engagement across all process and system improvement projects/initiatives, both those led within TMed and those led by external functional areas, inclusive of leading projects as required. They will also provide guidance to TMed Clinical process teams and subject matter experts (SMEs), facilitate issue resolution, improve workplace inclusivity, and represent TMed on cross-divisional teams and networks. Other primary responsibilities include supporting process quality, compliance and training strategies to ensure well-trained staff, equipped to perform clinical trial work. 

Key Responsibilities:

• Ensure clarity and efficiency of GCD SOPs and related documents, aligning them with current requirements and TMed's needs through active input during and outside formal review periods.

• Serve as the central coordinator for TMed Clinical US Operations by maintaining a comprehensive project inventory, assessing new project proposals for TMed engagement, assigning representatives, and monitoring projects to adjust resources as needed, while providing updates to leadership.

• Lead special projects and process improvement initiatives by developing strategic plans, identifying process inefficiencies, and fostering cross-functional collaboration, ensuring timely delivery and facilitating training for successful adoption of new processes.

• Oversee TMed SME assignments and process team memberships, co-leading the SME network to provide guidance and facilitate issue resolution within cross-functional teams.

• Provide leadership to SMEs in the design, development, review, implementation, and maintenance of SOPs, work instructions, guidelines, and process maps to ensure regulatory compliance and alignment with our Company policies.

• Represent TMed on cross-divisional teams, ensuring appropriate engagement in our Research & Development Division, GCTO, and GCD process and system initiatives, and negotiate the inclusion of compliant processes beneficial to TMed.

• Collaborate with global teams to identify and rectify shortcomings in processes, competencies, and verification methods, ensuring that all aspects of TMed Clinical operations function optimally while upholding necessary standards of process quality and compliance.

• Streamline information sharing by implementing effective communication strategies and collaborative tools, ensuring timely access to relevant updates and fostering a culture of transparency and teamwork to enhance overall communication and collaboration.

• Coordinate TMed-focused GCD Standard Forums for staff training, working with SMEs and the TMed Director of Quality, Compliance, and Training to proactively detect training needs.

• Nurture and expand strategic relationships with key stakeholders and partners to foster collaboration.

• Increase awareness and appreciation of TMed Clinical Operations for key functional areas that interact with similar processes and systems.

• Represent TMed on special projects, including pan-industry initiatives with groups like TransCelerate.

• Foster a climate of trust, clarifying roles and responsibilities to establish boundaries for decision-making.

• Collaborate closely with the Director of Quality, Compliance, and Training and to ensure alignment and effectiveness.

• Invest in the long-term development of team members through mentoring, coaching, and continuous feedback.

Education Minimum Requirement:

• Degree in Life Sciences

• Bachelor’s degree and ≥12 years related* experience, OR

• Master’s degree and ≥10 years related* experience, OR

• PhD or doctorate with ≥8 years related* experience

*e.g., clinical drug development, clinical trial/quality management

Required Experience and Skills:

• Expert knowledge of clinical development, GCP ICH guidelines and regulatory requirements, including recent Ph1 clinical trial operations experience

• Experience reviewing SOPs, with a strong attention to detail and picking up nuances for impact to business, training needs, quality and compliance

• Demonstrated expertise and excellence in process improve