Industry Clinical Collaboration Lead (x2)
Objectives and Scope of Position:
- ICCL is a core PDMA Medical Alliances Operations and PTDMX role responsible for providing the operational expertise and leadership to the cross-functional ICC to facilitate pharma and biotech clinical collaborations with external partners. The ICCL ensures the effective and efficient delivery of all operational collaboration aspects for a program of engagements with internal and external partners through all phases of Clinical Study Management (Start-up, Conduct, Close), in accordance with the appropriate quality standards including ICH/GCP, GVP, applicable regulations.
- The ICCL will be the primary point of contact with partner companies for day-to-day operations and contract negotiations.
- Takes the initiative, launches new projects, and leads collaborative activities within PTDMX and PDMA Medical Alliances Operations.
Summary of Main Responsibilities:
Provides direction and leadership of their collaborations
- Develops collaboration plans including: review of study implementation plans with partners, risk-mitigation, strategies, budgets, partner capabilities (if applicable), and clinical supplies management.
- Establish, maintain and closely liaise with Alliance Management regarding collaborators where there are co-development activities on going.
- Facilitates, chairs, and/or attends collaboration team meeting and organizes ongoing partner meetings and/or partner kick-off meetings, ass applicable.
- Manages kick-off meetings and works with Clinical Team, OPLs and ICCBL to identify team requirements, understand the study scope and development strategy and key terms to include in each potential ICC agreement.
- Builds the tasks and timelines for each potential ICC agreement.
- Liaises with Key Functions (Science, Operation, Technical, Quality, Legal and Safety) to execute the ICC agreement. Seeks inputs from those functions, coordinates the work and calls to review the agreements with Roche teams and external companies.
- Engages in the full process for ICC agreements and collaborates with PV Partnering and PTDX to ensure timelines are met and that no delays with agreement executions (Main, Quality, Safety) that could impact site activation or FPI.
- Support ICCBL with initial discussion and manages the negotiation and drafting of the ICC agreements based on the acquired knowledge/information from the team.
- Collates documents directly from the team members and external partner companies (protocol synopsis/IB sections/Country List/Biomarker plans) required for the ICC agreements.
- Keeps track of status of each ICC collaboration agreement and communicates regularly to Roche teams with the ICCBL.
- A primary Contact for External Companies and keeps track of Roche and External Companies commitments /obligations in the agreement and ensure those commitments/obligations are met without delay (Quarterly status reports, Press release, abstract/publications, data exchange, CSR, etc.). Responsible for tracking approval and maintaining repository for changes to study exhibits (protocols, supply plans, sample analysis, budgets, etc.)
- Responsible for triaging partner inquiries related to study implementation and management to internal cross functional team members
- Liaise with Roche Legal for agreement development, amendments and terminations.
- Is an effective and efficient high performing operations team member and ensures internal and external function members are aware of their accountabilities, responsibilities and deliverables.
- Supports, develops and maintains effective working relationships with internal and external, collaborative partners.
- Oversees the development and maintenance of collaboration specific templates and manuals.
- Oversees the supply forecast and informs stakeholder as required of any changes.
- Ensures the completion and finalization of any corrective and preventative action plans resulting from audits; ensures inspection readiness of the collaboration responsibilities as applicable at all times.
Responsible and/or contributes to the development and management of the collaboration timelines, resources, budget, risk and quality plans
- Responsible to identify and update tracking tools to meet the needs of the operations team and ensures timely reporting to the ICC members and stakeholders.
- Ensures ICC tracking and monitoring tools are optimized to ensure long-term implementation, sustainability and scalability.
- Develops and manages clinical supply forecast in association with the CDSL. Communicates variances in forecast and develops action plans for resolution to the ICCBL. Establishes study supply milestones and ensures accurate tracking and reporting of study metrics.
Responsible for the development and management of the collaboration quality requirements, collaborator supply chain information, quality agreement implementation, Quality release activities and regulatory impacting change assessments
- Responsible to identify, propose and implement the quality approach for the exchange of materials with collaborators and internal stakeholders.
- Responsible to establish internal SAP requirements for materials coming into Roche for Roche sponsored studies.
- Responsible to ensure all Regulatory impacting changes are assessed/addressed to ensure continued supply of materials to clinical trials.
- Responsible to ensure appropriate Quality organizations are engaged in processes that impact their processes of release activities.
Provides clinical operations expertise to ensure operational feasibility and delivery
- Develops the partner capability questionnaires (if applicable) and creates the Roche contribution to the collaboration risk management plan. Analyses the feasibility data across countries provided by the Alliance Partner with input from ICC stakeholders, Science, Quality, Safety and Legal and provides the strategic country and site distribution and patient numbers to the ICCBL.
- Provides operational input and insight into all partnering related documentation and processes.
Oversees forecasting of clinical/non-clinical supplies
- Designs drug assumption and supply chain process in partnership with Clinical Distribution and Supply Leaders and ICC members.
- Ensures that safety reporting is established and maintained for the duration of the collaboration and that reporting timelines are met.
- Proactively monitor actual study level recruitment versus planned patient recruitment status and communicates variance to the ICCBL and implements contingencies in consultation with the ICCBL.
- A primary contact for the Alliance Partners and ICC members to maintain oversight of performance, issues, and their resolution and identify systematic issues and coordinates any corrective action.
- Oversees the maintenance of drug supplies and resolution of issues with input from Clinical Distribution and Supply Leaders. Coordinates responses to collaboration questions or issues from Health Authorities or IRBs/IECs, as applicable.
Provides the day-to-day operational management of partnerships to ensure delivery against MCSA, Clinical Supplement(s), SDEA and MQA scope of work and commitments
- Develops and executes appropriate partner audit for adherence to agreement in collaboration with the ICCBL and PDQ.
Identifies areas of best practice and process improvements
- Participates in initiatives and programs as assigned.
- Maintains oversight and ensures consistency of the operational aspects across studies within the partner collaboration and ICC members/ stake holders.
Ensures study adherence to ICH/GCP, GVP, Roche policies and SOPs Compliance
- Is responsible for acting in line with legal, regulatory and company standards and codes of practice (e.g. Roche Code of Conduct, applicable Roche directives, guidelines and SOPs).
- Completes all required training modules as a priority.
Professional and Technical Requirements:
- Life sciences degree or nursing equivalent or substantial experience in a clinical research/a healthcare environment.
Responsible and/or contributes to the development and management of the collaboration timelines, resources, budget, risk management and quality plans. Responsible to identify and update operational tracking tools, including systems. Serves as the process responsible and ensures adherence by the ICC team members and ensures accurate tracking / reporting for the ICCBL. Establishes collaboration milestones and ensures accurate tracking and reporting of collaboration metrics.
Ability to work across organization at all levels. Ability to successfully achieve results within a multi-cultural diverse team. Excellent analytical and oral written communication skills. Strong project management and operational skills. Forward thinking and creative solution development. Sound understanding of legal agreements. Ability to influence and negotiate. Excellent Customer Mindedness. Ability to quickly establish trusted partnering skills. Fluency in written and spoken English.
Experience, Knowledge, Skills
Minimum 7 years of professional experience in Pharma industry and / or Clinical Research Organization and / or Academic Research Organization. Relevant scientific knowledge. Experience working in a cross functional/ multicultural environment. Experience in drug development and regulatory requirements for the conduct of clinical trials. Experience including the set-up of evidence generation activities for sponsored, supported or real world studies. Project Management experience. Shows clear mindset for agile way of working and has appropriate knowledge of agile methodologies (e.g. scrum, design thinking, lean etc.) Has broad capability of applying the methods depending on the context and need to generate impact.
- Some travel may be required to attend study related meetings.
- Collaboration organization, set up and follow –up
This position is not eligible for relocation support.
NOTE: All employment is conditional upon the completing and obtaining a satisfactory background check, including educational, employment, references and criminal records (for which a pardon has not been granted) checks.
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