Director, Medical Affairs Operations

Location
Cambridge, MA, United States
Posted
Oct 21, 2018
Ref
R-00870
Hotbed
Genetown
Required Education
Bachelors Degree
Position Type
Full time
Title:
Director, Medical Affairs Operations

Company:
Ipsen Biopharmaceuticals Inc.

Job Description:

Position Summary

The Director is responsible for leading research activities within US Medical Affairs, compound/therapeutic area leadership, study set up and execution, as well as all vendor management and sponsor oversight activities. Activities will include responsibility for Investigator Sponsored Study (ISS) operations, processes, and systems. Oversight of Medical Affairs Sponsored Study (MASS) operations, including vendor selection and management, protocol and study documents development, study start-up, maintenance, and closure. Candidate will serve in a leadership role within Medical Affairs managing direct reports, stakeholder management for cross functional teams, as well as partner/alliance management within clinical development. This position will report to the Sr Director, US MSL and Medical Affair Operations.

The Director, Medical Affairs Operations is responsible for the oversight of MASS and ISS programs conducted for Ipsen Biopharmaceuticals, Inc. with respect to: planning, implementation, coordination, reporting, and overall resource definition.

The Director ensures timely delivery and budget adherence in order to assist in the delivery of US Medical Affairs objectives.

Essential Functions

Responsibilities

Responsibilities will include, but are not limited to, the following:

  • Manage team with direct reports within Operations
  • Provide strategic input and leadership in study set-up and execution
  • Clinical Operations lead on cross functional project teams and alliance teams
  • Has overall oversight for MASS and ISS from an Operations perspective
  • The direct oversight of all outsourced providers, i.e. CROs, CRAs, central laboratories, Electronic Data Capture (EDC), etc. for MASS
  • Responsible for organizing and delivering relevant training to Medical Affairs Operations / CRO staff
  • Foster and develop a team approach to all activities associated with the implementation of the Medical Affairs research program
  • Establish and maintain excellent professional relationships between the company and external experts
  • Lead the feasibility and site selection processes for Medical Affairs Sponsored Studies with the support of the Ipsen Medical Science Liaisons (MSL) and CROs as applicable
  • Prepare detailed timelines and establishing clinical study milestones for assigned projects, ensuring they are performed according to the Protocol, Good Clinical Practice guidelines, and SOPs and further ensuring timely delivery and budget adherence
  • Identify, in alignment with the therapeutic area, high quality investigators and study sites for the conduct of clinical studies
  • Review and recommend amendments to the study protocols to ensure the study feasibility and to subsequently plan and organize work schedules
  • Ensure, in conjunction with the Regulatory, Pharmacovigilance and Data Management Departments, that the necessary regulatory, safety and data evaluation requirements are met to allow the conduct of clinical related activities
  • Participate in the selection of CROs and other external vendors and take responsibility for ensuring that CROs/vendors deliver in accordance with the specification, quality standard and timeframe set; manage CRO/CRA relationship as required
  • Prepare and/or manage the production of all documents necessary to implement and monitor the study in a professional, high quality and timely manner
  • As applicable, manage and train CRO partners, act as point of contact for MASS vendors
  • Ensure regular and timely liaison with appropriate Medical & Regulatory entities and provide regular and timely reports on all site performance changes including scope, schedules and resources; provide guidance and support to other Medical Affairs operations support staff so that the administration activity/CRA activities are carried out efficiently
  • Ensure preparation of Confidentiality Agreements and site investigational contracts according to internal Ipsen guidelines and liaise with Legal as appropriate
  • Contribute proactively to the efficient operation of the Medical Affairs Group and to systems (eDC, CTMS) and processes being planned and implemented; participate in the training on and preparation, review, generation/updating of SOPs
  • Participate in the preparation and review of clinical study reports as assigned
  • Participate in the preparation and review of regulatory submission documents as needed, including IND/NDA submissions, and IND/NDA update and supplements
  • Ensure the completeness of the Clinical Trial Management Systems for the Medical Affairs research program; provide training and regular support of all users including external Monitors and Site Personnel
  • Supervises and/or Performs User Acceptance Testing of the eCRF
  • Prioritize and schedule all matters related to the Medical Affairs Research program
  • Leadership of internal and external meetings (i.e. ISS Reviews, Investigator Meetings) related to the Medical Affairs research
  • Supervise the schedule of work for Medical Affairs Operations personnel and CROs
  • Develop metrics and provide regular updates for Medical Affairs research activities
  • Complies with all laws, regulations and policies that govern the conduct of Ipsen U.S. staff

Qualifications

Education
  • Bachelor's degree required, advanced degree preferred
  • Degree in Life Science preferred


Experience
  • 10+ years substantial relevant experience of pharmaceutical drug development including project management of company-sponsored and investigator-sponsored clinical studies (Pharma or CROs)
  • Minimum 5+ years' experience of project management for interventional clinical trials and/or registry type studies in oncology, endocrinology or neurology
  • Experience in team management
  • Excellent knowledge of Good Clinical Practice (GCP)/ICH regulations
  • Excellent understanding of industry guidance and best practices for ISS.
  • Experience preparing clinical study documentation.
  • Experience managing and developing relationships with research vendors
  • Experience compiling and managing clinical study budgets
  • Experience with developing, reporting, and tracking research performance metrics


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.