Senior Director, Head of Clinical Programs, Rare Disease
Title:Senior Director, Head of Clinical Programs, Rare Disease
Company:Ipsen Bioscience, Inc.
Overall accountability for global clinical development operational activities related to his/her assigned therapeutic area(s). Primary responsibility for this position will focus on directing all clinical operational activities for clinical study programs within the Rare Diseases Therapeutic Area (RDTA).
Ipsen works in an Asset Centric Model and as such this Head of Clinical Programs will ensure appropriate coordination with the relevant asset teams to address clinical operations needs for the respective development plans.
Main responsibilities / job expectations Clinical Study Operations activities: Provides operational and strategic drug development expertise and guidance for the design, implementation, timelines, resourcing and budgetary planning for clinical studies ( Phase 1-registration enabling and, if required, post approval commitment studies) within the RDTA: • Recruit, manage, coach, and develop clinical study operations teams located in any of the Ipsen’s R&D locations (Paris, Cambridge, Montreal and Oxford/Slough). • Enable effective integrated ways for team working that is harmonized with other TA clinical study operational teams, addressing executional excellence criteria related to the design, conduct and reporting of clinical studies. • Ensure efficient operational leadership of clinical study programs (planning, implementation, monitoring/controlling, budget controls, quality, communication, risk assessment and management, stakeholder management, procurement, vendor oversight…etc. • Ensure his/her assigned clinical study operations teams work in conjunction with the RDTA Medical Development Director (Study Physician), the Asset Lead and other members of the study project and product asset teams in the creation and seamless execution of study deliverables against the agreed development plan. • Enable effective collaboration between Global Project Management and clinical study operations teams and other key members of a product / asset team such as clinical supplies, data management, statistical and medical writing teams (whether in-house staff or via a CRO). Oversee all team members to ensure they are working in full compliance with ICH-GCP, FDA and other country regulations (including EMEA, Japan and China), in addition to company quality documents and business SOPs. • Ensure that adequate internal resources are forecasted and allocated to each assigned clinical study program • Ensure that an optimized study budget is developed, validated, approved and monitored according to defined procurement and financial control processes. • Ensure engagement of Service Providers in compliance with company defined outsourcing model, policy and procedure and enable effective Service Provider oversight and governance. • Ensure study team subject matter expertise contribution into R&D global operational processes (Polices, SOPS and associated documents) that underpin the overall Quality Management System, ICH-GCP, regulatory and business process needs for executional excellence. • Be an active contributing member of his/her assigned Therapeutic Area Team, fully engaged and hands on to drive study deliverables and timelines.
Due Diligence/Integration activities: Participate in Business Development/ Due Diligence teams (when requested), providing SME and strategic input in budget assumptions and development plans/timelines • Support and direct effective implementation of integration and business continuity for any new clinical development acquisition into RDTA Operational Excellence initiatives: Contribute to (or lead) cross-functional working groups within and outside R&D focused on delivering clinical trial excellence. Travel Requirements: The position will be predominantly office based in Cambridge, USA, however international travel may be required to ensure adequate oversight and management of the globally located clinical study operations teams. Some travel to other Ipsen site locations in Montreal, UK or France may be required on occasions.
Knowledge, abilities & experience
• Advanced Life science degree (MSc/ PhD plus relevant operational experience)
o Minimum 12-15 years’ experience in the Pharmaceutical Industry of which 5 years spent leading global clinical study operations teams at Director/Sr Director level (or equivalent)
o Significant experience in pharmaceutical drug development including project management of national and international programs either in Pharmaceutical/Biotech or CRO environment.
o 7+ years in people and project management
o Must be able to develop a robust study budget
o Significant experience with working in a hybrid outsourcing model with strategic providers ( FSO/FSP model). Capable of addressing issue escalation and governance needs between internal and external teams in a partnership manner.
o Intimate knowledge of ICH- Good Clinical Practice (GCP) and other worldwide regulations applicable to the conduct of clinical research
o Experience of working with multidisciplinary groups in a global matrix environment with demonstrable ability to work within cross-cultural team environments.
o Experience with Asset Centric Models a plus
o Experience with NDA (or other Health Authority submissions)
o Must have exposure to FDA and other regulatory authority inspections