Full Time /Permanent
My client is a private biopharmaceutical company focused on the development of gene therapies for retinal dystrophies. The Company’s lead program is a retinal gene therapy for choroideremia, an inherited form of progressive blindness, which is entering late phase clinical development. The company recently closed a series B financing round and expanded its pipeline with 5 licensed pre-clinical programs.
The company was founded in the UK and is establishing a US subsidiary with offices based in Boston, Massachusetts. The position provides a unique opportunity to join a growing company and be part of a dynamic, forward-thinking team.
Job Description:
The Program Manager, through partnership with the Program Director, has significant responsibility for driving, operationalizing, and executing the company’s strategy.
The Program Manager will support 2-3 programs depending experience level and the stage of development (ranging from newly identified pre-clinical opportunities to programs in early clinical development).
The Program Manager will need to have a commanding knowledge of drug development processes and will be responsible for managing the activities from all functional areas, (i.e., clinical, regulatory, safety, pre-clinical, CMC) allowing rapid progress to successful Phase I/II application and execution in Europe and the US.
The role will facilitate cross-functional collaboration through the management of regular team meetings focused on advancing the program to the next decision point and ensuring alignment with the overall company strategy. He/she will also work closely with team members in the creation of an aligned, integrated development plan designed to deliver the products strategic objectives.
A key responsibility will be to track activities and deliverables and report any variances to cost, timelines, or emerging product profile. Communication and appropriate escalation of risks/issues is essential, and the PM will be expected to troubleshoot as needed. He/she must also be comfortable and skilled in working with virtual internal and external team members.
This position will have dual reporting lines into the Director, Program Management based in London, UK and the Chief Scientific Officer based in Boston, US.
Major Duties and Responsibilities:
· Drives cross-functional, operational integration for drug development, including coordinating cross- functional activities and communications involving team members.
· Manages Project Team meetings, including leading discussions to drive to effective decision-making, agenda creation, and issuing meeting minutes.
·Identifies issues and facilitates problem-solving, contingency planning, and decision-making.
· Works to develop, maintain, and align an accurate, integrated Drug development plans, timelines and budget.
· Understands critical path activities, anticipates risks, and creates contingency plans.
· Ensures linkage between strategy and operational activities and collaborates with cross-functional team members to support execution of deliverables.
· Partners closely with the Program Director and CSO to shape the Program strategy, goals and plans and ensure tight alignment within the project team on strategy, goals and deliverables.
· Generates analyses to facilitate scenario planning, contingency planning, risk assessment and management, problem-solving, and decision-making.
· Ensures central access to key program documents, presentations, and assessments.
·Supports Program Director in preparing program updates for management team and Board of Directors.
Qualifications & Experience:
· BS or MS degree in a scientific field – required
· PhD in relevant field – desirable
·Project management qualification such as Prince 2, PMP etc. – highly desirable
·6+ years of experience in pharma/biotechnology industry – required
· 3-5+ years of experience in pharma/biotechnology industry project management role with demonstrated knowledge of Project Management tools e.g. MS Project – required
·Understands overall biologic product development process, with experience in viral or gene/cellular therapy and/or orphan drug development an advantage
· Demonstrated track record of working collaboratively in a cross functional environment, and leading people without reporting authority
· Proven track-record of successful project management experience working on pre-clinical/Phase I/II development programs
Knowledge & Skills
· Excellent interpersonal skills with particular emphasis on communication, influencing, & relationship building. Can articulate vision and motivate the team.
·Highly organized and able to work independently on multiple tasks in a fast-paced environment and manage competing priorities.
·Readily adaptable to change and new challenges.
· Rapid and agile decision-maker who can lead the team in soliciting and analyzing multiple points of view. Can exert good judgment regarding when to elevate issues to Sr. Management.
·Excellent planning, project management, and problem-solving skills.
· Ability to create, coordinate, and maintain an integrated product plan and to control or respond to changes in strategy and scope.
·Distinctive communication (oral, written, and presentation), analytical, and strategic thinking skills.
·Strong collaborative skills to assure alignment of strategic and operational plans across functions and geographies. Flexible and positive approach.
·Ability to challenge product/project assumptions in order to resolve conflicts, optimize timelines and cost through sound knowledge of early-phase drug development.
· Expertise in use of project management software solutions (MS Project), including skills in critical path analysis.
· Skilled in use of MS Office (PowerPoint, Excel, Word).