Director, Clinical Programs, Oncology and Rare Diseases

Location
Cambridge, MA, United States
Posted
Aug 20, 2018
Ref
466533
Hotbed
Genetown
Required Education
Bachelors Degree
Position Type
Full time
Title:
Director, Clinical Programs, Oncology and Rare Diseases

Company:
Ipsen Bioscience, Inc.

Job Description:

Purpose of the Position
  • To provide clinical and operational expertise and guidance for the design, implementation, resourcing and budgetary planning for Oncology clinical programs managed through Development Project Teams (DPT) and/or Global Project Team (GPT).
  • To work in conjunction with the TA Medical Expert and the Global Project Leader(s) (GPLs) and other DPT members in the creation and seamless execution of deliverables (e.g. Target Product Profiles, Project Team Objectives, Integrated Development Plans or Submission dossiers, forecast and budget).
  • To be the key contact point and representative for all clinical related activities at DPT/GPT level
  • To lead the clinical development program (planning, implementation, monitoring/controlling, budget, quality, communication, risk assessment, stakeholders management, procurement etc, ) ensuring the full integration of studies management within the Global Project Management
  • To ensure cross functional oversight of all study related activities (TA, PV/CMC/GRA...)
  • To plan clinical research personnel resource under program area of responsibility in agreement with the TA clinical operations head
  • To recruit, manage, mentor, train, review, develop and appraise all Clinical Project Managers (GCPMs), Clinical Leads (CLs) and Clinical Trial Assistants (CTAs) within area of responsibility in collaboration with the TA Clinical Operations head.
  • To ensure selection and global CRO oversight through the supervision of Ipsen GCPM or early phase studies Partner's CRM.
  • To provide expert Oncology clinical support to Business Development as required during Due Diligence activities and ensure that TA clinical operations Head concurs with the assessment and recommendations
  • To analyse and recommend solutions to the Oncology clinical operations Head and other Heads of Department within the TA on the organisation and participation in effective clinical trial programs
  • To drive changes in processes for continuous improvement and adaptation to business model changes


Essential Functions
  • 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 TA clinical operations Head to ensure alignment at DPT level, in order to support the delivery of clinical development objectives and achieve Clinical Excellence.
  • To coordinate, an initial budget proposal and updates with all necessary HoF inputs, track, reconcile and manage the budgets associated with these Clinical programs, and secure approvals by the TA clinical operations Head, TA head and GPLs as required for the project success. To ensure that this information is timely and accurately forwarded to the Finance department.
  • 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 the TA 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 GCPM, 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
  • To advise and participate in CRO selection led by the Outsourcing and Purchasing department, providing support to Ipsen GCPM for CRO oversight and ensuring consistency within and across programs,
  • To participate and contribute along with Purchasing and Outsourcing departments to CRO 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 the TA clinical operations Head from time to time.
  • Complies with all laws, regulations and policies that govern the conduct of Ipsen U.S. staff


Qualifications

Educations & Experience
  • Significant relevant experience (minimum of 7 years) of Oncology pharmaceutical drug development including project management of national and international programs.
  • Experience in line and team management
  • Experience as GCPM
  • Experience of working with multidisciplinary groups and ability to work within a team environment.
  • Experience of managing and developing relationships with Contract Research Organizations (CROs).
  • Experience of compiling and managing clinical study budgets.
  • Excellent organization and management skills
  • Excellent verbal and written communication skills.


Core Competencies
  • Life science or other relevant qualifications
  • Intimate knowledge of Good Clinical Practice (GCP).
  • A good understanding of the drug development process.
  • Computer literacy


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.

Ipsen Bioscience, Inc. is an equal opportunity employer. We recruit, employ, train, compensate, and promote without regard to race, religion, creed, national origin, age, gender, sexual orientation, sexual identity, marital status, military or veteran status, disability, genetic information, or any other category protected by applicable federal, state or local law.

Ipsen Bioscience, Inc. conducts background screening, reference checks, and drug testing as part of its pre-employment screening process. 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.