Director, Due Diligence & Integration, TAT Clinical Programs

Ipsen•Cambridge, MA

About The Position

The Director, Due Diligence & Integration, TAT Clinical Programs will serve as a core member of the CDO teams in charge of TAT and/or Integration activities ensuring successful onboarding / transition / integration of new assets and CDO team members across all Therapy Areas (TAs). The TAT Director will provide Clinical Operations expertise to integrate any new assets at Ipsen and will collaborate and support the DDI & TAT CPD in the transition of the acquired clinical studies to Ipsen. For TAT activities, this role will take responsibility for overseeing the CRO clinical /site management activities of the acquired clinical studies in accordance with regulatory requirements, Good Clinical Practice (GCP) guidelines and applicable SOPs in order to assist in the delivery of Clinical Development objectives during the transition phase. For acquired company and/or asset Integration, the Director will drive and manage clinical operations related integration activities to ensure successful onboarding of any new CDO members into Ipsen and/or ensure efficient and smooth transition of acquired clinical trials into Ipsen ways of working.

Requirements

15 years of related experience with a bachelor’s degree, 12+ with a Master’s degree; or a doctorate (PharmD/MD/PhD) with 8 years’ experience; or equivalent experience.
6+ years relevant experience within clinical research or study management environment
4+ years clinical trial management experience.
Knowledge of the clinical study environment with strong theoretical or practical administrative and organizational capability
Comfortable working across any therapeutic area and development stage, as TAT team assignments may span all assets; therefor Phase 1 through Phase 3 experience is essential
Experience working with multidisciplinary groups and ability to work within an asset team environment
Experience managing and developing relationships with Contract Research Organisations (CROs)
Experience coordinating, compiling and tracking clinical study budgets.
Excellent organisational and prioritization skills, with strong attention to detail
Ability to work within a highly regulated environment and quality management system (QMS)
Advanced knowledge of standard software applications (for example Word, Excel, PowerPoint, Adobe Reader)
Intermediate financial knowledge with the ability to work with financial tracking tools
Knowledge of pharmaceutical industry research and development
Good knowledge of Good Clinical Practices (GCP) and other applicable clinical study regulations
Fluent in English.

Nice To Haves

Experience supporting the transition of clinical assets in or out is an advantage
Master’s degree or higher in a relevant scientific, clinical, or research focused field strongly preferred

Responsibilities

Review study status vs planned activities, assess any impacts and/or risks and provide recommendation to the DDI & TAT CPD for any mitigation actions, as required.
Manage any clinical study activity delegated by the DDI & TAT CPD, such as the project management and monitoring of clinical studies, including liaison with monitors, CROs, drug vendors, central laboratories and other vendors, as applicable.
Oversee the CRO clinical and site management activities to monitor adherence to study protocol, regulatory requirements and GCP guidelines.
Participate in study feasibility as applicable and lead the site feasibility assessment (CDA preparation and collection; Study questionnaires to sites etc…).
Collect the relevant study information and set up clinical study dashboard as per Ipsen way in collaboration with the TAT CPD.
Organize appropriate logistics for any Sponsor meetings and all internal study team meetings as applicable.
Perform the assessment and track the new asset clinical studies external vendor contracts /change orders, including gap and impact analysis, in collaboration with the procurement and legal teams.
Collaborate, with the procurement and legal teams on the preparation of transition plans for existing contracts, generation of contract templates, ensure contracts are fully executed and archived and collection of any legal documents as needed.
Collaborate with the insurance department team for tracking the status of clinical trial insurance, preparing any transition plan for any existing clinical study insurance, and proactively request insurance certificate and renewals.
Coordinate the dispatch order for the clinical supplies if not managed by a dedicated system such as IVRS, meaning the collection of appropriate documents permitting to obtain import license and release study drugs in collaboration with the CMC Supply Chain team.
Coordinate the collection of appropriate study essential documents, such as Clinical Study Report (CSR) appendices within the agreed timeframe and validate the accuracy of contents against the actual study status in collaboration with the CRM/CPM to support the medical writer assigned to the study.
Prepare and execute the transition plan for the new clinical asset electronic Trial Master File (TMF) (and/or paper TMF, if applicable) to ensure full integration and compliance with Ipsen processes.
Manage and track the study financial documents, including commitment requests, Internal Order, Purchase Order, goods receipt & invoices, within the Ipsen financial K2 system, as applicable and support the clinical study budget management and monitoring according to the financial control process.
Assess the new clinical asset disclosure of expense collection and reporting process and prepare a transition plan in collaboration with the DDI & TAT CPD and the Local Transparency Manager (LTM) or the Global Transparency Manager (GTM) to track, collect and disclose study expenses according to Ipsen processes and in compliance with regulations in force: EFPIA disclosure code (Europe), Sunshine Act (US).
Assess the new clinical asset reporting tool and/or CTMS and prepare a transition plan in collaboration with the DDI & TAT CPD, ensure all required study data are properly tracked and always up to date in the eCTMS.
When needed, conduct or coordinate the Service Provider or internal team trainings to Ipsen tools or processes.
Set-up and maintain up to date shared CDO transitional folders and study electronic site (SharePoint, box or other tools).
Ensure successful handover of Clinical Operations activities to the Study Team/Asset team assigned to take over the project from the TAT team.
Be active member of CDO Integration team supporting the DDI & TAT CPD and proactively lead some sub-meetings for the transition of Clinical Operations Activities to Ipsen Ways of Working. This includes but not limited to SP/Vendor scope of work/agreement, TMF, CTMS, expenses transparency, insurance, data transparency and regulatory disclosure and financial aspects.
Manage, prepare and collect relevant clinical operation documentation to be appended to the change control and the Integration Story Board.
Coordinate the preparation and communication of the Integration newsletter.
Contribute to the Q&A sessions with the acquired legacy CDO team, as applicable.
As assigned by his/her line manager, onboard, mentor or train new team members.
Comply with applicable EHS regulations and procedures.
Participate in the site's EHS performance by reporting risks, malfunctions or improvements
Participate in mandatory EHS training.