Project Director

Simbec-Orion•Boston, MA

About The Position

We are looking for a Project Director to join our Project Management - Clinical Development team where you will have full project management responsibility for all aspects of phase I-IV patient clinical studies from start-up to close-out managed according to Simbec-Orion (and/or Sponsor) Standard Operating Procedures (SOPs), ICH-GCP and local regulations. Studies managed will be “complex” or "non-complex" studies, with any number of participating countries or investigator sites. You may also work on a single large study or several studies as oversight with Project Managers managing day to day tasks. You will provide support to Commercial Development to win new or repeat business by inputting into Requests for Proposals (RFP) based on experience of managing studies with the same sponsor or similar studies as the RFP. You will represent the PM department on RFP strategy calls in place of the Director / Senior Director, Project Management and you will provide input and insights to leadership to influence the department / organisation's strategic direction.

Requirements

Degree or equivalent level qualification in life sciences / related area or equivalent combination of education, training and experience.
Experience of managing several full service projects within a Clinical Research Organisation (CRO) or pharmaceutical industry.
Experience with managing global Phase 1- III patient studies
Excellent communication and presenting skills in English.
In depth knowledge of, and skill in applying ICH-GCP guidelines and any other applicable clinical research regulatory requirements.
Fully experienced with using tools such as eTMF and CTMS.
Expert knowledge of project finances that includes revenue recognition and forecasting of professional fees, pass through costs and Investigator fees.
Highly motivated and able to work and plan independently and in a team environment.
Ability to solve challenging problems balancing facts and logic
Experience of inputting strategy for RFPs received by Business Development.
Experience of overseeing projects or programmes.
Experience with Mentoring and supporting colleagues
Experience with developing SOPs

Nice To Haves

Expert experience with MS Project or other Project Management software.
Line management experience.
Experience in Rare & Orphan Diseases.
Experience in early phase Oncology dose escalation studies.
Experience in adaptive design studies.
Experience with leading change processes.

Responsibilities

Act as the primary point-of-contact and liaison with the Sponsor to provide outstanding customer service and serves as an ambassador to promote Simbec-Orion’s high quality and ethical image.
Provide oversight to Project Managers on large studies or several smaller studies and on directly managed studies lead and manage the cross-functional project team.
Communicates with internal Department Heads and Senior Management to evaluate study needs, resources and timelines.
Manage project contractual deliverables, agreed timelines, quality/scope and cost, including monitoring progress via metrics and when overseeing studies, manage in conjunction with the PMs.
Develop appropriate study management plans in collaboration with service leads and PMs when overseeing studies.
Manage risks on Projects and resolve issues on assigned studies or in conjunction with PMs when overseeing studies.
Manage and identify vendors who provide services in support of the projects (for example, IRT/RTSM, third party laboratories, meeting organisers).
Management and reporting of project finances including management of out of scope activities as per Simbec-Orion processes on studies that are directly managed.
Represent Project Management department on internal business development strategy calls for new opportunities in place of the Director / Senior Director, Project Management, when required.
Prepare presentation slides for Project Management aspects and co-ordinating delivery of presentation slides from the cross-functional project team for Bid Defence meetings and contribute to the discussions and present slides as agreed at the internal preparation meeting.
Line manage and provide technical leadership, training and mentoring to Project Managers.
Act as point of escalation for Sponsor PM on studies when acting as oversight.
Support with reviewing and writing of departmental SOPs.