Vice President, Clinical Development Operations, Rare Disease

Clinical Development Operations:

Summary / purpose of the position

The focus of this position will be Rare Disease Asset. Is accountable for all clinical operations strategy and delivery related activities to assets within the Rare disease Therapy Area (TA). Directs and provides clinical operational subject matter expertise and guidance for the design, implementation, resourcing, and budgetary planning for assigned clinical programs. Directs clinical operations teams ensuring appropriate study planning, implementation, monitoring/controlling, budget, quality, communication, risk assessment, stakeholder’s management, procurement etc)

Ensures Asset Team deliverables are met with respect to clinical development plan objectives. Ensures cross functional collaboration, risk management and issue resolution on all studies within assigned TA and ensures appropriate selection and oversight of vendors selected to support assigned clinical programs. He/she will be on the CDO-Leadership Team, representing clinical operations, supporting due diligence, manage hiring and performance/development of their direct reports and rare disease clinical operations team.

Clinical Development Operations:

Main responsibilities / job expectations

• Overall accountability for clinical studies across the rare disease TA. Accountable for outlining the clinical operations strategy and ensuring the clinical studies deliver on-time, within budget and quality
• Leads clinical operations teams responsible for planning, implementing and completing clinical studies with overall line management responsibility for development, support, review, training and appraisal of all direct reports
• Ensures oversight of creation and seamless execution of deliverables for assigned Asset(s)
• Works closely with the Medics and TA heads in outlining the Target Value Profiles (TVP), Clinical development plans (CDP), Asset Team Objectives related to clinical deliverables. Responsible and accountable for preparing the clinical operations plans, timelines/costs/resource needs for the governance meetings and Portfolio Reviews
• Oversee development of budget proposals and change orders and ensures tracking, reconciliation and management of the study budgets by clinical operations
• Responsible for managing relationships with the Service Providers (SP) and vendors managing the programs
• Ensures appropriate resourcing in place to deliver on clinical programs
• Serve as SME as required during development of clinical documents (e.g. study concept, annual updates of the Investigator Brochures, IND, Briefing documents etc.…)
• Advise and ensure robustness in the vendor selection in compliance with corporate policy
• Ensure appropriate clinical operations support before and during submission periods, including inspection readiness and regulatory inspection follow up
• Ensure functional teams work within the framework and in compliance with Global SOPs, and other documentation in force within the Ipsen Group, ensuring timely completion of all training.
  
  

Leadership / Management

• Lead the members of the clinical operations team by example.
• Implement best practices and standards for trial management in collaboration with other members of the clinical operations team, including establishment of SOPs.
• Leadership: Responsible for the talent development, provides mentorship and supervision of team members in his/her group. 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.
• Due Diligence: Serve as expert clinical operations support during due diligence missions and ensure alignment with the Due Diligence Lead and TAU Head on the assessment, proposed CDP and recommendations back to the BD teams.
• Direct and support recruitment, management, mentoring, training, and development, performance evaluations of staff within area of responsibility.
• Analyse and recommend solutions to the Heads of Clinical Programs and other Heads of Department within CDO and R&D on the organization and participation in effective vendor management of clinical study programs.
• Support changes in processes for continuous improvement and clinical trial excellence. Implements innovative strategies into their clinical programs
• Advocates and brings innovative capabilities into CDO team at Ipsen so we stay at the forefront of clinical operations capabilities
• Interface with and present at various senior management level meetings including but not limited to ELT, RDLT, GMALT, PROCUREMENT LT... etc.
• Sit on CDO-LT, Site/Facilities Committees and other external committees as needed
  
  

EHS Responsibilities:

• Complies with applicable EHS regulations and procedures.
• Participates in the site's EHS performance by reporting risks, malfunctions or improvements.
• Participates in mandatory EHS training
  
  

Knowledge, Abilities & Experience

Qualifications and experience required:

• Advanced ( e.g., Master's and above) degree in life sciences
• 20 + years' experience in Pharma, Biotech or CRO. Experience in leading clinical operations teams on global complex programs and franchises
• Experience in Rare Diseases, Oncology and Neurology in developing operational strategy and then delivery on these programs
• +10 years of line management experience managing global teams
• Experience of working with multidisciplinary groups and ability to work within an asset team environment.
• Experience in regulatory inspection.
• Experience in developing RFPs, selection of CROs/vendors, and management of external resources
• Demonstrated ability to manage international clinical trials within designated program budgets and timelines
• Proven success participating in cross-departmental clinical strategy, planning and implementation activities. (Departments include senior management, regulatory, QA, CMC, program management, finance, business development, medical affairs, clinical development and medical writing.)
• Strong working knowledge of FDA, EMA regulations and expectations, Good Clinical Practice, ICH guidelines, and clinical operations best practices.
• Demonstrated independence, problem-solving abilities, self-motivation, resourcefulness and ability to work in a fast-paced team environment.
• Experience with building clinical operations infrastructure including writing of SOPs.
• Excellent communication skills with an ability to efficiently and productively communicate both orally and in writing.
• Experience presenting to the senior leadership team is a plus.
• Excellent organizational and management skills
  
  

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
• Flexible; independent problem solving and self-direction.
• Eager and interested in learning and growing