Director Clinical Development Programs, Neuroscience

Title:

Director Clinical Development Programs, Neuroscience

Company:

Ipsen Bioscience, Inc.

Job Description:

Are you a clinical operations leader with experience leading programs in neuroscience?

As the Director Clinical Development Programs, Neuroscience, you will provide clinical and operational expertise and guidance for the design, implementation, resourcing and budgetary planning for clinical programs managed through Asset Teams.  You will work in conjunction with the Therapeutic Area Medical and/or Research External Innovation Early Development (REED) Expert as applicable, and the Asset Operational Leader(s) (AOLs) and other Asset Team members in the creation and seamless execution of deliverables (e.g. Target Value Profiles, Asset Team Objectives, Development Plans or Portfolio Review).  The Director will lead the clinical development program ensuring the full integration of studies management within the Global Project Management plans and will ensure cross functional oversight of all study related activities (TA/PV/Pharm dev/GRA/QA…).  The Director will report to and support the Head of Clinical Programs for the planning, resourcing and management of clinical research personnel under program area of responsibility and recruit, manage, mentor, train, review, develop and appraise all Clinical Project Managers (CPMs), Clinical Monitoring Leads (CMLs) and Clinical Trial Assistants (CTAs) as applicable, within area of responsibility, in collaboration with the Head of Clinical Programs.

Your role will involve:

• Overall line management responsibility for development, support, review, training and appraisal of all direct reports

• Coordination and management from a program project centric perspective all internal and external project management resources involved in the clinical programs

• Ensuring that the timelines and all key requirements for clinical project plans are followed and appropriately shared with the Head of Clinical Programs to ensure alignment at Asset Team level, in order to support the delivery of clinical development objectives and achieve Clinical Excellence.

• Coordinating an initial budget proposal and updates with the support of the project financial controller and with all necessary Head of Finance inputs, track, reconciling and managing the budgets associated with these Clinical programs, and securing approvals by the Head of Clinical Programs, Head of CDO, and AOLs as required for the project success. Ensuring that this information is timely and accurately forwarded to the Budget and Resources Team 

• Overall accountability for clinical studies within a Program in respect of: ensuring a high quality, ethical, cost efficient way to meet timelines and patient recruitment goals through validation of key activities (study budget preparation, study timelines, country/site selection etc…)

• Ensuring that cross-functional total headcount involved in CDO in a clinical study allows an appropriate conduct and delivery on time and quality of deliverables

• Providing expertise as required as a contributing author in the development of clinical documents (e.g. study concept, annual updates of the Investigator Brochures, IND, Briefing documents etc…), and provide with the assigned dedicated CPM,  an expert/functional review of  study documents (e.g. Protocol, Reporting and Analyzing Plan, Clinical Study Reports and other key documents) during the course of the clinical program

• Advising and participating in the SP selection in collaboration with the Procurement department and CTE function, providing support to Ipsen CPM for SP oversight and ensuring consistency within and across programs.

• Participating and contributing along with Procurement department to SP oversight meetings

• Attendance and contribution as required to advisory boards, expert scientific committees.

• Contribution as clinical expert in the submission team as applicable.

• Fostering and developing a team approach to all activities associated with the implementation of clinical studies.

• Completing all the above activities within the framework and in compliance with Global SOPs, and other documentation in force within the Ipsen Group, ensuring timely reading and understanding of relevant SOPs.

• Performing any other activity as may reasonably be required by Head of Clinical Programs from time to time

• Acting as an effective team leader. Responsible for the talent development, provides line management and supervision of team members in his/her group. You will be responsible for building capabilities and technical skills within the group to ensure effective high-quality delivery.

In return, you will bring:

Education

Life science or other relevant qualifications (Bachelor’s Degree required)

Experience

• Significant relevant experience (minimum of 7 years) of pharmaceutical drug development including clinical project management of national and international programs.

• Experience in Neurosciences notably in Parkinson’s disease and other Neuro rare disease

• Experience in line and team management

• Intimate knowledge of Good Clinical Practice (GCP)

• Experience working with multidisciplinary groups and ability to work within a team environment

• Experience managing and developing relationships with international Service Providers (SPs)

• A good understanding of the drug development process

• Experience of compiling and managing clinical study budgets

• Excellent organizational and management skills

Apply today if you are interested in learning more about this new opportunity!

IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.