Associate Director, Global Clinical Project Management - Oncology and Rare Diseases

Location
Cambridge, MA, United States
Posted
Nov 12, 2018
Ref
479865
Hotbed
Genetown
Required Education
Doctorate/PHD/MD
Position Type
Full time
Title:
Associate Director, Global Clinical Project Management - Oncology and Rare Diseases

Company:
Ipsen Bioscience, Inc.

Job Description:

Position Summary
  • Oversee and drive all aspects of the assigned global international clinical study(ies) outsourced to a CRO in respect of planning/timelines, quality, budget and defined goals
  • Drive execution and report activities in conjunction with Clinical Development Program Directors (CDPDs), Medical Dev. Directors (MDDs), and other Ipsen team members
  • Endorse project plan developed by the CROs in accordance with study objectives and Ipsen requirements in terms of team responsibility, risk mitigation plan, escalation process, communication plan...
  • Ensure the Global clinical studies are managed according to Good Clinical Practice (GCP), local regulations, guidelines and SOPs in the required standard of quality
  • Communicate and share the progress of the project, and work effectively as a Team
  • Lead, Manage and Drive the cross-functional Clinical Study Team and Contract Research Organization (CRO) in collaboration with the CDPDs and Ipsen team members responsible of the study


Essential Functions

Ensure study team management and communication
  • Oversee and drive cross-functional leadership and expertise to ensure effective contribution, execution and delivery of study activities as per quality, plan/timelines and budget
  • Foster a team approach to all activities associated with the implementation, conduct and closing of clinical studies including Ipsen clinical study team members (TA, Biometry, Pharmacovigilance, Finance controlling, Global Regulatory Affairs, CMC Supply chain...) and CROs
  • Establish and maintain excellent professional relationships with Services Providers / CROs, clinical study team through regular communication, between company, investigators and experts in conjunction with Medical Dev. Director (MDD) and other relevant Ipsen team members


Lead clinical project processes
  • Lead cross-functional clinical study teams focused on conduct of assigned projects
  • Interact with CDPD to define strategic direction
  • Review status reports provided by Service Provider/CRO and highlight issues to facilitate decision making
  • Manage and lead all operational aspects for implementation and conduct of global clinical trial activities from study start-up to CSR, in respect of GCPs and relevant SOPs


Key Accountabilities and Activities
  • Set-up study team before Services Provider / CRO are on board and lead and manage regular internal Study Team meetings during the course of the study.
  • Contribute to study protocol development including study concept where applicable
  • Develop and control planning and study timelines in collaboration with all other Ipsen supportive functions/CRO
  • Provide expertise to clinical outsourcing specifications and purchasing to facilitate RFP documents and selection of Services Provider/CRO
  • Participate in the selection of Services Providers /CROs and other external vendors in collaboration with purchasing department, study team and Corporate Legal Affairs
  • Accountable for the development, management and tracking of trial budget working closely with the finances and service provider representative - financial management of the clinical trial including budget planning and preparation of quarterly reports
  • Ensure appropriate oversight of Services Providers /CRO(s) and other external vendors activities and develop the oversight manual in accordance with the services providers Technical Specifications document
  • Review final draft and approve major study documents as described in the Services Providers /CROs Technical Specification documents (e.g. oversight manual, communication plan, project plan, instruction manuals....)
  • Supervise country feasibility and site selection processes in collaboration with CDPD, MDD, GMA, CRO and Ipsen Affiliates (if needed) to identify and gain approval for high quality investigators and study sites
  • Provide support and oversee the activities of the Clinical Trial Assistant (CTA) assigned to the study for: insurance certificate, contracts signature process, set-up and management of the Trial Master File (eTMF), transparency and local reporting as per legal and Ipsen requirements, update of reporting tools (study trackers, Hermes,...) and alert if required; drive billing and forecast
  • As applicable, provide support and oversee the activities of the Clinical Lead (CL) to ensure the coordination of the clinical, monitoring and site management activities are in accordance with study objectives and quality standards.
  • Work with the CRO, Patient Affairs office, and digital team as appropriate to develop and approve a recruitment strategy and communication tools (e.g. Newsletter...) to increase study awareness, patient recruitment and retention in the study
  • Ensure through study team management that the necessary regulatory, safety and data evaluation requirements are met to allow the conduct of clinical related activities in conjunction with the Regulatory, Pharmacovigilance (GPS), Data Management and Statistics Departments
  • Participate in meetings lead by CRO (e.g. Inv. & CRA meeting, Study team meeting, Clinical Data Review ... ), Review meeting minutes and ensure with CRO Project Manager that issues are proactively identified, communicated and resolved in a timely manner
  • Ensure timely and accurate completion of project milestones, study progress tools (planning reporting, study dashboard...) and escalate appropriately in case of deviation to the planning and of any issue regarding the quality of the data
  • Oversee and drive cross-functional leadership and expertise to ensure effective contribution, execution and delivery of study activities as per quality, plan/timelines and budget
  • Foster a team approach to all activities associated with the implementation, conduct and closing of clinical studies including Ipsen clinical study team members (TA, Biometry, Pharmacovigilance, Finance controlling, Global Regulatory Affairs, CMC Supply chain...) and CROs
  • Establish and maintain excellent professional relationships with Services Providers / CROs, clinical study team through regular communication, between company, investigators and experts in conjunction with Medical Dev. Director (MDD) and other relevant Ipsen team members
  • Lead cross-functional clinical study teams focused on conduct of assigned projects
  • Interact with CDPD to define strategic direction
  • Review status reports provided by Service Provider/CRO and highlight issues to facilitate decision making
  • Manage and lead all operational aspects for implementation and conduct of global clinical trial activities from study start-up to CSR, in respect of GCPs and relevant SOPs


Clinical activities (out of studies):
  • Contribute/participate on SOP update and review training material created by Process Training Management
  • Contribute to the efficient operation of the TA Group and to transversal project cross- TAs and other departments within Ipsen (e.g. systems implementation, change management initiatives, continuous improvement initiatives ...)


QUALIFICATIONS

Education:
  • Life science or medical graduate or other relevant qualifications


Relevant experience of pharmaceutical drug development:
  • Coordination of clinical activities for the set up and running of international registrational studies, for at least 2 years
  • Experience in managing and developing relationships with Contract Research Organizations (CROs)
  • Experience in working with multidisciplinary groups (internal & external), flexibility, adaptability and ability skills to work within a matrix environment.


Core Competencies:
  • Ability to work with minimal supervision as well as in a team environment
  • Strongorganizational and presentation skills
  • Strong relationship, teambuilding, customer-focused orientation coupled with the ability to deliver results and meet or exceed agreed-upon objectives and timeframes:
  • Personal flexibility and a proactive orientation;
  • Ability to handle multiple priorities.
  • Ability to work under time and resource constraints.
  • Commitment to excellence and high standards.
  • Good understanding of the drug development process and knowledge of the pharmaceutical industry environment
  • Excellent leadership skills and capability to work within a team as leader and team player
  • Excellent organizational and management skills
  • Intimate knowledge of regulatory requirement (ICH E6, GCP, EU Directive)
  • Strong verbal and written communication skills (English, French is a plus)
  • Written, Verbal, and Interpersonal: excellent


Essential Functions - Physical Demands & Working Conditions:
  • PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)
  • Regularly required to operate standard office equipment (computer, copy/fax machine, etc.)
  • Ability to work on a computer up to 7 hours a day and occasionally sit or stand or walk for long periods of time
  • Ability to work in a dynamic environment which can include but not limited to office, laboratories, manufacturing, off-site venues, etc. depending on functional role.
  • Standard office environment. Potential interaction with laboratory environment with exposure to chemicals.
  • Close vision required for computer usage.
  • Occasionally required to stoop, kneel, climb and lift up to 30 pounds.
  • Required to consistently and properly use Personal Protective Equipment in keeping with Ipsen safety policies and practices.

Environmental, Health Safety Requirements:
  • Comply with all corporate and facility Environmental, Health and Safety policies and procedures. Attend all mandatory EH&S meetings and complete all EH&S training requirements.
  • Intervene in potentially unsafe situations and report any incident, unsafe acts, conditions or equipment. Report any emergency situation (medical emergency/chemical spill/security concern) by following established emergency programs and procedures.


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.