Director, Due Diligence & Integration (Clinical Development Operations)
Title:Director, Due Diligence & Integration (Clinical Development Operations)
Company:Ipsen Bioscience, Inc.
CORE JOB RESPONSIBILITIES/ACCOUNTABILITIES:
- Accountability for developing efficient and robust integrated processes for harmonizing and optimizing due diligence to enable CDO assessment and integration activities
- Accountability for efficient and effective coordination of CDO subject matter expertise input into due diligence assessments for new assets being reviewed by the BD team as part of Ipsen’s external innovation model.
- Contributes as an SME to assigned due diligence reviews supporting the VP CDO, Due Diligence and Integration with all activities as assigned.
- Accountability for partnering with Integration Leads in GRDO and cross functionally within CDO to ensure effective planning and monitoring of CDO activities for acquisitions
- Develop robust integrated processes, appropriate guidelines and plans for harmonizing and optimizing due diligence CDO assessment and integration activities.
- Monitor the execution of the CDO asset integration is according to plan, budget and quality.
- Develop CDO Key Performance Indicators and Reporting dashboards for due diligence and integration activities.
- Provide CDO related input to business development/ due diligence teams in collaboration with the other CDO team members, as applicable (e.g. statistics, clinical operations in each TA area) and other cross-functional due diligence teams.
- Make thorough review of available data in the virtual data room for the assigned due diligence assessments.
- Provide CDO expertise (or obtain the relevant input from other SME within CDO) into the clinical development plans ensuring appropriate scenarios, risk assessment and mitigation strategy
- Prepare external clinical development cost estimates and associated CDO resources and capacity needs for the assigned due diligence asset, in collaboration with R&D finance.
- Provide CDO expertise and oversight of effective integration and business continuity for any assigned clinical asset acquisition, working in the integration planning team and participating in the transition agreements (TSA) preparation.
- Lead the CDO team in charge of the assigned clinical asset integration and monitor its execution to ensure it is according to plan, budget and quality.
- Collaborate closely with the cross-functional due diligence and integration teams to ensure seamless due diligence assessment and integration execution.
Operational Excellence initiatives:
Contribute to cross-functional and working groups within and outside R&D focused on delivering clinical trial excellence.
Some international travel will be required from time to time for business needs.
Qualifications & Experience Required:
- Life science or other relevant qualifications (minimum MSc, PhD preferred given the scientific assessments required for this role but not essential with relevant experience)
- Significant relevant experience (minimum 8 years) and thorough understanding of pharmaceutical drug development process, including project management of national and international programs.
- Experience in people/team management. Must have experience working with multidisciplinary groups globally located cross functional and cross-cultural team environment.
- >5 years’ experience in conducting clinical/scientific based due diligence assessment and/or integration of clinical assets in a pharmaceutical /biotech environment
- Intimate knowledge of ICH- Good Clinical Practice (GCP) and other worldwide regulations applicable to the conduct of clinical research
- Experience in rapidly compiling clinical study budget estimates in the absence of a full detailed development plan, including benchmarking study/site costs
- Strong organisational and time/project management skills.
- Strong diagnostic, analytical and process improvement skills. Willing to work with agility in a very fast moving team structure and capable of providing opinions where not all the facts are as yet known
- Superior verbal and written communication skills. Comfortable and professional within senior and executive level meetings
- Ability to see the big picture, while keeping an eye on the detail.
- Flexible; independent problem solving and self-direction.
- Computer literacy
- Fluent in English