Director Clinical Development Programs
- Ipsen Biopharmaceuticals, Inc.
- Cambridge, Massachusetts
- Start date
- Mar 17, 2023
- Clinical, Clinical Development, Clinical Research
- Required Education
- Bachelors Degree
- Position Type
- Full time
Title:Director Clinical Development Programs
Company:Ipsen Bioscience, Inc.
Job Title: Director Clinical Development Programs
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 execution 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 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 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 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
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 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 cross-cultural 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 self-direction.
- Eager and interested in learning and growing
One Ipsen Way of Being
(The below apply for all employees and described how to act with a biotech way of being)
We Trust Each Other
- Respect each other and all our stakeholders
- Empower others
- Respect & be open to inclusion and diversity
- Enable feedback and foster a speak-up culture
- Embrace cross-team collaboration
- Be transparent and share information
We share and learn every day
- Be proactive in learning from each other and through experiences
- Listen and be open to views and needs of all external stakeholders
- Seek transformation through innovation
We own our outcome
- Be accountable and responsible
- Set clear expectations and prioritize
- Be results and value driven, not task-oriented
- Bring solutions
- Seek continuous improvement to be better always
- Own our Company Social Responsibility strategy
We honor our word
- Walk the talk & talk the walk
- Ensure that we make ethical decisions, stay compliant at all times
- Never compromise on quality
- Care for our employees, patients and society and the environment
We drive to win together
- Be entrepreneurial
- Fast in turning our ideas into action; be agile
- Be demanding of ourselves as we strive for success
- Believe in making a difference
- Celebrate success
- Enable talent inclusion and diversity
Other Useful Information
- Key Internal stakeholders:
- Key External contacts:
- Financial budget:
- Number of direct reports:
- Travel: The position will be predominantly office based though travel will be a necessary pre-requisite in order to effectively support the Group and the Development programs
The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.
This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time. The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values.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.
Ipsen (Euronext: IPN; ADR: IPSEY) is a global, biopharmaceutical group focused on innovation and specialty care. The group develops and commercializes innovative medicines in three key therapeutic areas - Oncology, Neuroscience and Rare Diseases. At Ipsen, we focus our resources, investments and energy on discovering, developing and commercializing new therapeutic options to provide hope for patients whose lives are challenged by difficult-to-treat diseases. Ipsen's North American operations and headquarters are located in Cambridge, Massachusetts, where our fully integrated biopharmaceutical team across External Innovation and Partnering, Research & Development (R&D), Manufacturing and Commercial collaborate. Cambridge is home to Ipsen's third global hub, in addition to R&D centers in Paris-Saclay in France and Oxford in the United Kingdom. With additional offices in Basking Ridge, N.J. and Mississauga, Ontario, Ipsen employs approximately 600 people in North America. For more information on Ipsen in North America, please visit www.ipsenus.com or www.ipsen.ca.
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