Project Manager II - Early Development Team (EDT), Translational Sciences

Description

Who We Are

From research and discovery to post-market clinical development, our WWRD engine involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with genetic diseases.

POSITION SUMMARY:

This individual project manages drug development programs for the Research and Early Development (RED) organization that range from late-stage research, IND-enabling, through post approval phases, for both nonclinical and clinical endeavors. This individual will partner with the drug program Early Development Team (EDT) Lead in driving the operational and strategic direction in order to meet the program's corporate goals and objectives, within budget and on time, primarily concerning Research, Bioanalytical, Immunogenicity, Clinical Pharmacology and Toxicology. This individual will identify and manage project-related priorities; maintain and track high-quality integrated project plans and dashboards to enable accurate reporting and decision making; enable effective team meetings and high-performance teams; manage risk assessment/escalation; develop strategies for monitoring progress and for intervention/problem-solving in collaboration with stakeholders. The Project Manager interacts with individuals within RED as well as across all departments ranging from Drug Discovery to Commercial to ensure corporate goals are met.

RESPONSIBILITIES:

• Responsible for project managing 2-3 programs in late-stage research/IND-enabling and/or clinical development phase for the RED organization.
• Facilitates the integration of all key workstreams supporting the product.
• Drives collaboration and transparency, while influencing the team's critical thinking with inclusive strategic planning.
• Develops detailed project schedules that integrate key activities, timelines, and tracks the critical path for assigned projects.
• Develops, independently and as part of a team, decision-making methodologies, tools, and solutions for the EDT to identify complex issues with cross functional mid- to long-term project- and program-level impact.
• Manages project risk assessment and reporting to applicable stakeholders.
• Responsible for ensuring and analyzing accurate budget and resourcing requirements are maintained for each functional group within the EDT, and escalating change or out of scope requirements.
• Partners with the EDT Lead (EDTL) to facilitate the Team meetings, including but not limited to, meeting organization, meeting summaries and follow up on cross-functional actionable items.
• Partners with the EDTL to schedule as-needed local departmental Governance meetings to discuss strategy, emerging data, budget/resourcing, and align on data-driven decisions.
• Utilizes strong influence management skills with the EDT functional leads to coordinate cross-functional efforts and meet overall team objectives. Functional leads include Toxicology, Clinical Immunology, Clinical Pharmacology, Bioanalytical Sciences, Research, and other ad-hoc members such as Clinicians, Nonclinical Study Management, Regulatory, CMC etc.
• Manages SharePoint Team Collaboration Sites and associated dashboards for the EDT alignment and communication.
• Maintains EDT's OKRs (Objectives and Key Results), keeping the team on track and communicating change, risk and impact.
• May mentor and/or supervise junior staff.
• Other duties as assigned.

EXPERIENCE:

Required Skills:

• 4-8 years of work experience in drug development (pharma/biotech or contract research organization), with a minimum of 3-5 years of direct project management experience in early and/or late stage clinical development
• Ability to drive, motivate and enable effective team meetings and high performing teams, while developing and maintaining professional interpersonal relationships with colleagues
• Strong understanding of GLP, GCP & GMPs
• Strong documentation, organization and time management skills in a fast-paced environment

• Experienced with Project Professional software
• Minimum: Bachelor's (BS/BA) in Biological Sciences or closely related field

Desired Skills:

• Experience in the overall drug development process across various modalities including Gene Therapy, Biologics & Small Molecule
• 2-4 years of nonclinical project management experience for IND-enabling (2+ drug class types)
• Strong familiarity with Regulatory submission requirements (IND through BLA/NDA)
• Experience with nonclinical study management/monitoring
• Experience with Microsoft Excel, SharePoint, PowerBI (PBI) and Microsoft Teams
• PMP certification preferred (or equivalent)
• We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.