Director, Clinical Development Programs H/F

Hiring By - Biostaffic

 BioPharma

France

Job Highlights

Not Disclosed

Posted 4 months ago
Job details
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
  • To work in conjunction with the TA Medical and/or REED Expert as applicable, and the Asset Operational Leader(s) (AOLs) and other AT members in the creation and seamless execution of deliverables (e.g. Target Value Profiles, Asset Team Objectives, Development Plans or Portfolio Review).
  • To be the key contact point and representative for all CDO related activities at AT level
  • To lead the clinical development program (planning, implementation, monitoring/controlling, budget, quality, communication, risk assessment, stakeholder’s 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 (TA/PV/Pharm dev/GRA/QA…)
  • To ensure selection and global SP oversight through the supervision of Ipsen CPM
  • To provide expert clinical support to Business Development as required 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 Monitoring Leads (CMLs) 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 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, and AOLs as required 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 cross-functional 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 required 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
  • For company acquisitions or licensed assets, as requested, provide subject matter expertise in effective integration planning, implementation and monitoring of integration activities within the CDO integration team in collaboration with CDO integration Lead.
Leadership / Management
  • Is an effective team leader. 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 high-quality delivery.
Collaborates with team members to drive strategic team decision-making and deliver on commitments to the organization and to patients.
Knowledge, Abilities & Experience
Qualifications and experience required:
  • Life science or other relevant qualifications
  • Significant relevant experience (minimum of 7 years) of pharmaceutical drug development including clinical project management of national and international programs.
  • Experience in Neurosciences and other Neuro rare disease ( eg Huntington’s chorea)
  • Experience in line and team management
  • Intimate knowledge of Good Clinical Practice (GCP).
  • Experience of working with multidisciplinary groups and ability to work within a team environment.
  • Experience of 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 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 - Ability to see the big picture, while keeping an eye on the detail.
  • Organisational strategic awareness and proven ability of developing strategic solutions
  • Strong leadership and line management capability and experience with cross-cultural understanding and sensitivity
  • 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 self-direction.
  • Eager and interested in learning and growing
  • Excellent IT and Microsoft Office skills
Other Useful Information
  • Key Internal stakeholders: CDO, Asset team, Finance Controlling, R&D Operations, R&D Quality
  • Key External contacts: Clinical Service providers
  • Number of direct reports: at least four
  • Travel: The position will be predominantly France office based though travel will be a necessary pre-requisite in order to effectively support the Group and the Development programs

Benefits Offered?

  • No

Bonus Offered?

  • No

Travel Required?

  • No

Location:

  • France

Global Experience Needed?

  • No

Specialized Experience Needed?

  • No

Apply before:

  • Apr 12, 2024
Company Overview
Ipsen
Ipsen

Current Openings: 0

Ipsen is a French leading global mid-size biopharmaceutical company headquartered in Paris, France focusing its efforts where unmet medical needs are greatest. Ipsen develops and commercializes innovative medicines in three key therapeutic areas - Oncology, Rare Disease and Neuroscience. We have over 5000 employees worldwide and our medicines are registered in more than 100 countries, with direct commercial presence in over 30 countries. Ipsen has 4 global R&D hubs and 3 pharmaceutical development centers around the world.
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