Clinical Program Oncology Director FM
Clinical Program Oncology Director FM
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Job Description
Title:
Clinical Program Oncology Director F/MCompany:
Ipsen Innovation (SAS)Job Description:
Summary / purpose of the position
To provide clinical and operational expertise and guidance for the design implementation resourcing and budgetary planning for clinical programs managed through Asset Teams and/or Global Project Team (GPT)
To work in conjunction with the TA Medical and/or REED Expert as applicable and the Asset Operational Leader(s) AOLs and other AT/GPT members in the creation and seamless of deliverables (e.g. Target Product Profiles Asset/Project Team Objectives Integrated Development Plans or Submission dossiers forecast and budget).
To be the key contact point and representative for all CDO related activities at AT/GPT level
To lead the clinical development program(s) (planning implementation monitoring/controlling budget quality communication risk assessment stakeholder management procurement etc.. ensuring the full integration of studies management within the Global Project Management plans
To ensure cross functional oversight of all study related activities TAPV/CMC/GRA)
To ensure selection and global SP oversight through the supervision of Ipsen CPM
To provide expert clinical support to Business Development as during Due Diligence activities and ensure that Head of Clinical Programs concurs with the assessment and recommendations
To support the Head of Clinical Programs for the planning resourcing and management of clinical research personnel under program area of responsibility.
To recruit manage mentor train review develop and appraise all Clinical Project Managers (CPMs) Clinical Leads (CLs) and Clinical Trial Assistants (CTAs) as applicable within area of responsibility in collaboration with the Head of Clinical Programs.
To analyse and recommend solutions to the Head of Clinical Programs and other Heads of Department within CDO and R&D on the organisation and participation in effective clinical trial programs.
To drive changes in processes for continuous improvement and adaptation to business model changes.
Main responsibilities / job expectations
To take overall line management responsibility for development support review training and appraisal of all direct reports
To coordinate and manage from a program project centric perspective all internal and external project management resources involved in the clinical programs
To ensure 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 AT/ GPT level in order to support the delivery of clinical development objectives and achieve Clinical Excellence.
To coordinate an initial budget proposal and updates with the support of the project financial controller and with all necessary HoF inputs track reconcile and manage the budgets associated with these Clinical programs and secure approvals by the Head of Clinical Programs Head of CDO andAOLs as for the project success. To ensure that this information is timely and accurately forwarded to the Budget and Resources Team
To take 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)
To ensure that crossfunctional total headcount involved in CDO in a clinical study allows an appropriate conduct and delivery on time and quality of deliverables
To provide 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 to provide with the assigned dedicated CPM an expert/functional review of study documents (e.g. Protocol Reporting and Analysing Plan Clinical Study Reports and other key documents) during the course of the clinical program
To advise and participate 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.
To participate and contribute along with Procurement department to SP oversight meetings
To attend and contribute as to advisory boards expert scientific committees.
To contribute as clinical expert in the submission team as applicable.
To lead in fostering and developing a team approach to all activities associated with the implementation of clinical studies.
To complete all of 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.
To perform any other activity as may reasonably be required by Head of Clinical Programs from time to time
Leadership / Management
Responsible for the talent development provides line management and supervision of team members in his/her group. The individual is responsible for building capabilities and technical skills within his/her group to ensure effective highquality delivery.
Collaborates with team members to drive strategic team decisionmaking and deliver on commitments to the organization and to patients.
Qualifications and experience :
- Life science or other relevant qualifications
Significant relevant experience (minimum of 7 years) of pharmaceutical drug development including project management of national and international programs.
Experience in line and team management
Intimate knowledge of Good Clinical Practice (GCP).
Experience as CPM
Experience of working with multidisciplinary groups and ability to work within a team environment.
Experience of managing and developing relationships with Service Providers SPs).
A good understanding of the drug development process.
Experience of compiling and managing clinical study budgets.
Excellent organisational and management skills
Excellent verbal and written communication skills.
Computer literacy
Key Technical Competencies Required
Strong people skills with the ability to communicate / interact at all levels within the business and with external partners
Strong diagnostic analytical and process improvement skills
Organisational strategic awareness and proven ability of developing strategic solutions
Strong leadership and line management capability and experience
Excellent IT and Microsoft Office skills
Strong attention to detail excellent and direct communication skills strong interpersonal skills and crosscultural understanding and sensitivity
Managerial capability with strong leadership profile
Ability to see the big picture while keeping an eye on the detail.
Ability to represent the company in a highly professional manner.
Ability to take initiative with a positive attitude in all circumstances.
Flexible; independent problem solving and selfdirection.
Eager and interested in learning and growing
#LIHybrid
#LIMC1
Required Experience:
Director
Employment Type
Full-Time
