GeneCoda has been retained to identify and evaluate candidates for a (Senior) Project Manager to be located in the Research Triangle Park, NC.
About Our Client:
Our client is an innovative, drug development company leveraging machine learning techniques to redesign and optimize drug candidates for known and well validated drug targets.
Our client’s platform enables them to identify novel and better drug candidates based on information from products that have failed in the clinic.
Our client is seeking an accomplished drug development scientist with experience in leading program management from development candidate molecule through IND-filing. The (Sr) Project Manager will work with preclinical project teams and scientific leadership, and CROs developing TPP’s, and driving project strategy and execution. The ideal candidate will have filed at least one small molecule successful IND.
Initially, the (Sr) Project Manager will take over project management of our client’s most advanced candidate. Our goal for the new hire is to successfully manage the project leading to an IND approval in the first year of employment.
- Leads program management activities for development candidates, preclinical development, and IND-filing.
- Works closely with chemistry and machine learning teams and company leadership to drive programs into early clinical development.
- Leads project management for development teams through continuously driving cross-functional coordination and communication to ensure programs and projects are successfully executed within agreed budgets and timelines.
- Manages CRO relationships to enable effective execution of program goals and objectives.
- Prepares, manages timeless for, monitors status of and submits INDs.
- Prepares plans for and oversees CRO work involving clinical Phase 1 and 2.
- Leads meetings to track deliverables and timelines for all development programs.
- Partners with management to develop schedules, budgets and identify resource requirements.
- Identifies and analyzes project plans for contingencies and risk mitigation to maintain milestone dates.
- Develops, maintains, and monitors comprehensive project plans to enable accurate reporting and decision making.
Education: A BS in chemistry, chemical biology, pharmacology, or related scientific discipline. An advanced degree (MS, PhD) is desired. PMP certification is a plus.
Experience and Qualifications:
- 5+ years of project management experience with prior experience in a development stage biotechnology or pharmaceutical company.
- Prior experience in drafting INDs and managing Pre-IND meetings.
- CRO oversight related to all IND-enabling studies.
- Preparation and maintenance of target product profiles (TPP).
- Prior small molecule experience is desired.
- Proficiency with MS Project and Gantt Chart’s.
- Strong collaborative skills. Team player mentality.
- Effective decision-making and problem-solving skills.
- Able to handle complexity and ambiguity as well as be able to prioritize, organize and manage multiple projects simultaneously.
- Excellent interpersonal skills.
- Excellent verbal and written communication skills.
GeneCoda refers qualified applicants for all jobs without regard to race, color, religion, creed, age, sex, disability, marital status, national origin, pregnancy, family medical history or genetic information, sexual orientation or preference, Vietnam Era Veteran status or other protected military status or any other status protected by federal, state, or local law.