Penfield Search Partners
Contact: Neisha Camacho/Terra Parsons – firstname.lastname@example.org
JOB DESCRIPTION: The Project Manager will identify, track, and integrate the companys key drug development and regulatory timelines, identify dependencies and risks of key milestones, and assist with identifying options for achieving specified timelines. Responsibilities include both pre-clinical and clinical development programs. This person will be a key resource to the clinical development and regulatory groups.
- Work with all clinical core program team members to integrate activities from each function (Clinical, CMC, Research, Regulatory, Finance, Commercial, Medical Affairs) into overall clinical program timelines
- Work with all pre-clinical core program team members to integrate activities from each function (Clinical, CMC, Research, Regulatory, Finance, Commercial, Medical Affairs) into overall pre-clinical program timelines
- Work with program teams to identify dependencies among key milestones and deliverables
- Work with program teams to identify risks to key milestones, deliverables, and timelines and assist staff in identifying options to mitigate these risks
- Ensure program team meetings are held as need to accomplish team activities and that meeting minutes are available in a timely manner
- Be responsible for development of content by each team for presentation to senior leadership at Governance Committee meetings
- Identify and track detailed timelines for planned New Drug Application (NDA) submissions and amendments, should there be any
- Develop and track other timelines as needed by the Chief Medical Officer and Head of Research
- Promptly convey any potentially significant risks to key milestones and deliverables to the Chief Medical Officer and Head of Research
- Will report directly to the Chief Medical Office and Head of Research and be a member of the leadership teams of the Clinical and Research groups. As such, this Project Manager will be considered a key leader in these groups.
SKILLS & REQUIREMENTS:
- BS Degree
- 5 + years experience managing timelines/projects relevant to drug development.
- An understanding of the overall drug development process and basic knowledge of regulatory requirements, with hands-on experience
- Relevant experience in Clinical Development and/or Regulatory Affairs project management
- Relevant experience as a line-manager is a plus
- Ability to use verbal and written communication and negotiation and interpersonal skills to achieve understanding and accurate updates of timelines from across the company