Position – Global Program Manager
The Global Program Manager will be responsible for leading and providing oversight for our multiple phase trials including our most advanced clinical stage program, NLY01. This person will serve as the key interface across all departments including Clinical, Non-Clinical, Regulatory Affairs and R&D Management. The successful candidate will have strong leadership skills as validated by having previously delivered results in a similar role within a multi-disciplinary, matrixed environment that also required in-depth technical knowledge of Biologics product development.
•Responsible for development and communication of the overall project strategy including budgetary oversight and control.
•Facilitate effective planning and documentation with all Project Team members to define development requirements, timelines, risks/gaps, contingency plan and resource requirements for project execution.
•Develop and maintain MS Project GANNT charts for all assigned projects.
•Prepare monthly high-level status reports for senior management.
•Ensure cross-program coordination, cross-functional alignment and organizational support for the execution of the program plan.
•Manage multiple projects’ day-to-day needs (internal and external) to ensure each project is executed on time and on budget.
•Ensure successful implementation, tracking and revision of project plans for assigned projects.
•Communicate timely, appropriate project information to the CSO and internal department leaders
•Promote effective teamwork among project team members; helping to resolve conflicts as needed.
•Managing project resource needs in conjunction with functional heads and establish contingency plans for key resources.
•Facilitate the initiation of process improvements to enhance the efficiency and the quality of work for all studies conducted at the US site.
•Monitor the progress of each individual project deliverable against project plan and budget.
•Ensure written approval of all amendments to a contract or budget is obtained prior to initiating any project-related procedures as determined by the functional group.
Education and Experience:
•Bachelor’s degree in relevant technical discipline required
•Advanced degree and/or Project Management Professional (PMP) certification preferred.
•Minimum five (5) years of pharma/biotech/CRO experience required
•Minimum two (2) years of direct Project Management experience.
•Working knowledge of all phases of drug development including general understanding of GLP, GMP and GCP preferred
•Demonstrated understanding of project management principles applicable to the biopharmaceutical environment
•Excellent communication skills, both oral and written, as well as proven conflict management and negotiation skills
•Demonstrated ability to balance scientific, technical and business objectives
•Demonstrated leadership skills required
•Excellent time management skills and must be able to prioritize projects.
•Proficiency with MS Project
•Attention to detail to ensure accuracy of data and adherence to project requirements.
Position – Associate Director, CMC Management
The Associate Director, CMC Management is responsible for planning, coordinating and managing CMC activities for all Neuraly pipeline products. This includes, but is not limited to, analytical / process / product development, technical transfer, regulatory documentation, clinical manufacturing and packaging. The Associate Director leads CMC activities and coordinate with external and internal stakeholder to ensure quality and compliance with timelines and budgets. This person will work closely with CROs/CMOs and internal stake holders e.g. Pre-clinical, Clinical, Regulatory, and Quality, etc..
•Review CRO/CMO proposals and implement studies to ensure sound scientific rationale, efficient approach, comprehensive process / product understanding, and fit for regulatory expectation for analytical, process, and product development projects.
•Manage project startup, tech transfer, and cGMP drug substance and drug product manufacturing.
•Manage clinical supply, including demand assessment, inventory tracking, labeling/packaging and distribution activities
•Serve as project manager for CMC activities; proactively identify and communicate progress, issues, risks and mitigation plans to broader team and management.
•Assist regulatory filing (IND / IMPD) preparation.
•Organize project information using best practices and tools. Document decisions and lessons learned. Champion knowledge management practice.
Education and Experience:
•Ph.D., M.S. or B.S. degree in Biology, Chemistry, Engineering or other relevant life science discipline with at least 8 years’ relevant industry experience. Level of position may be adjusted based on level of competency and years of experience.
•Knowledge and broad understanding of the CMC approaches, requirements and relevant regulatory guidelines in Pharmaceutical Development and cGMP manufacturing operations. Late stage development and product registration experience preferred
•Experience interfacing with internal operations groups and CROs/CMOs
•Experience participating in and leading cross functional teams such as CMC teams
•Demonstrated ability to apply and establish best practices of project management
•Excellent oral and written communication skills
•Passionate to work in a people orientated, start-up environment.
•Ability to independently and rapidly evaluate impact of new information, anticipate solutions, identify the need for decisions, frame issues, inform impacted stakeholders and drive resolution using inclusive, collaborative approach and sound judgement
Position – Toxicologist
The successful candidate will be responsible for design and oversight of preclinical safety assessment for all Neuraly and Theraly products and will report to the VP of Translational Medicine and Regulatory Affairs. This person will lead and manage our toxicology programs, communicating toxicology plans, results, and reports to FDA and other regulatory authorities as needed. Considerable prior experience managing safety assessment studies is expected. A strong background in toxicology including extensive knowledge and understanding of ICH requirements and Good Laboratory Practices is required.
•Design and oversee the conduct, interpretation, and reporting of regulatory toxicity studies
•Plan, design, and effectively manage/conduct and oversee designated toxicology programs necessary to support the selection and timely development of potential drug candidates through close interactions with consulting toxicologists, and affiliated nonclinical and clinical development functions as necessary
•Coordinate toxicological/nonclinical safety evaluations of development candidates locally and internationally with CROs and consultants
•Aid in authorship of pertinent sections of internal and external regulatory documents (IBs, IND sections, briefing documents etc.)
•Coordinate resolution of toxicological issues arising in drug development programs, to allow adequate assessment of the relevance of any toxicological findings to human safety.
•Collaborate on design of investigative toxicity studies in support of development compounds as needed
Education and Experience:
•MS, Ph.D. in Toxicology or DVM with relevant toxicology experience
•DABT Board certification a plus
•5 plus years of experience in the pharmaceutical/biotech industry with a proven track record of conduct of drug safety assessment studies, demonstrated ability to manage multiple scientific projects, make sound scientific interpretations and provide risk assessments
•Experience with Pharmacokinetic (PK) analysis is a plus.
•Proficient knowledge of general toxicology
•Working knowledge of US and ICH regulatory toxicology requirements
•Experience with design and execution of GLP toxicology studies required for safety assessment of biologics including PK and ADA assessment
•Experience with GLP toxicology study design required for safety assessment of small molecules a plus
•Strong interpersonal skills with an ability to develop solid working relationships and to work effectively in a team setting/matrix-type organization
•Oral and written communication capabilities sufficient for successful management of CROs and regulatory writing