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Job: Director of Program Management, Locus Biosciences, Research Triangle Park, NC
Director of Program Management
Research Triangle Park, NC 27560 United States
Locus Biosciences is an emerging biotechnology company developing novel antimicrobials with its patented Type I CRISPR-Cas3 technology leveraging bacteriophage delivery to prokaryotes. This platform will enable the design and development of powerful antimicrobials that avoid currently known antibiotic resistance mechanisms while leaving non-target bacteria unharmed. Locus is advancing its platform to create therapeutics for critical disease areas ranging from resistant bacterial infections, such as E. coli and C. difficile, to the microbiome.
Locus is seeking a motivated Director of Program Management that is eager to solve problems that have never been solved before. The ideal candidate is motivated to join a fast-paced work environment with the opportunity to take an indication through an approved therapeutic. He/she will be responsible for the implementation development strategy spanning from pre-IND through BLA filing. The Director of Program Management will be responsible for the complete asset, and will be coordinating with cross-functional teams and serving as the key interface with pre-clinical, clinical, and regulatory affairs.
• Responsible for managing the entire drug development lifecycle for multiple infectious disease and microbiome indications including; pre-clinical study execution, IND submission, CMC, clinical study execution, and BLA submissions.
• Provide direction and oversight to cross functional project teams, including internal and third-party CROs. Ensure team focus and accountability to achieve goals and deliverables.
• Lead development of the activities and timelines and ensure proper integration and alignment with the overall project plan.
• Collaborate with functional representatives to anticipate and identify project risks and develop action and resolution plans.
• Maintain the plan and timelines; monitor and control deliverables, budget and scope.
• Establish and maintain effective communication channels to provide accurate information to the leadership team.
• Prepare monthly status reports and internal team documents.
Job Type: Full-time
Job Location: Research Triangle Park, North Carolina
For immediate consideration, please email your resume or CV to: email@example.com.
Direct applicants only. No agencies please.
• A BS degree in Biology, Biochemistry, Genetics or a related field; PhD preferred.
• Seasoned project management professional with a minimum of 5-8 years of experience. Candidates must have well-established history in project management and program management.
• 2-5 years’ experience in either a top-tier management consultancy, pharmaceutical development organization, or contract manufacturing organization required.
• Experience working with third party CMOs and CROs on validation and product launches required.
• Experience with animal trials and experiments required.
• History of interacting with the FDA required as well as experience with IND submissions for Biologics License Application (BLA). Experience using electronic document management and the eCTD submission process is critical.
• Experience with complaints, adverse event, and CAPA required.
• Experience with Pharmaceutical Development (CMC) and Clinical Trials Services (CTS) is required.
• Strong analytical skills and business acumen specific to operational activities with a strong proficiency in MS Office and mastery of MS Project. Work samples will be required.
• Experience with Operational Excellence programs a real plus.
• Experience writing regulatory documents for FDA review a plus.
• Excellent interpersonal skills with the ability to effectively communicate to all levels within the organization, including Board of Directors.
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