We are seeking a Clinical Project and Portfolio Management Lead, who has extensive experience in the clinical drug development process. This position will partner with multiple members of the clinical development team and manage programs bridging discovery stage entities into the clinic as well as through the various stages of clinical development and into commercially viable therapeutics. The successful applicant will report to the Chief Medical Officer and have the unique opportunity to impact the strategy and execution of multiple projects in support of Kallyope’s pipeline.
The Clinical Project and Portfolio Management Lead will work cross-functionally and collaboratively with Medical, Regulatory, Nonclinical, Development Operations (multiple functions), Business Development, CMC, R&D, Finance, and Legal to support development and Life Cycle Management activities.
- Create and oversee the integrated program/project plan and adapt as changes to the program strategy arise.
- Facilitate strategic discussions across various internal functional team member leads and implement a full project plan for all assigned projects.
- Act as the team liaison to ensure that proactive actions and risk mitigation scenarios are developed to ensure project plan goals are met.
- Manage MS Project schedules (or equivalent), project reports, team agendas, team meeting minutes, and team budget summaries.
- Collaborate with finance and cross functional areas within the development structure to plan, address, and manage resource needs across the program.
- Support development of program governance procedures as well as other infrastructural elements of the Clinical Project and Portfolio Management department.
- Ensure development team activities align with the project plan and ensure communication of progress to all necessary entities throughout the life of the program.
- Work with finance as well as internal partners to ensure accurate forecasting and accruals for clinical programs.
- Prepare reports and/or presentation materials aimed at summarizing program status, metrics, issues, risks for senior management, business development initiatives, BOD meetings, or governance activities.
- Compile and maintain up-to-date project plans, collating key metrics across the team, tracking progress of activities against plan, notifying relevant personnel of potential delays and/or issues, and ensuring that key milestones are achieved in a timely manner.
- Direct highly complex project communications and ensures that all project team members are fully informed and knowledgeable of project activities and their status.
- Organizes preparation of high-quality documents for review by internal management in collaboration with the project team and represents the Development Team at relevant meetings, when needed.
QUALIFICATIONS AND EDUCATION REQUIREMENTS
- M.S. (preferred) or B.S. in biology, chemistry or related discipline, or equivalent industry experience
- Minimum of 10 years of industry experience (Biotech/Pharmaceutical) including 5 years of clinical drug development experience
- Minimum of 8 years of Project Management experience required
- In depth knowledge of the drug development process including familiarity with country level regulatory pathways (i.e., Pre-IND, IND, NDA, MAA).
- Understanding and application of principles, concepts, practices, and standards of pharmaceutical project management
- Advanced knowledge and skill with Microsoft Project, Microsoft Excel, Power Point, and other reporting and tracking tools
- Past experience, direct or indirect, with supporting business development and/or alliance management tasks or initiatives
- Ability to synthesize information and demonstrate strategic thinking
- Strong organizational and communication skills, attention to detail
- Demonstrated ability to work effectively in a collaborative setting
- Demonstrated initiative and ability to develop, communicate, and implement successful strategic initiatives for multiple constituents with sometimes conflicting / competing objectives and goals
Additional preferred experience includes:
- Project Management Professional (PMP) or other certification
- Prior experience with regulated document environments