Director/ Senior Director Project Management, Translational Medicine, Clinical Pharmacovigilance, and Regulatory Affairs
New Haven, Connecticut /
Research & Development – Research & Development /
The Project Manager will partner with the project leads in Toxicology, Translational Medicine, Clinical Pharmacology, and Regulatory Affairs (TM, CP, RA) to assist with laying out timelines to execute the activities expected of each function in support of BioXcel Therapeutics pipeline products. The Project Manager will be responsible to ensure that the activities & plans set up by functional leads are tracked for timelines and budget. The Project Manager is responsible for working with functional leads to develop/manage/coordinate budgets & contracts with external vendors, external consultants and other needs across each line functions. Using strong project management skill, the Project Manager coordinates TM, CP and RA strategy development and implementation. The project manager will plan and manage TM, CP and RA project activities, including the development and maintenance of budgets and timelines and participate in decision-making and risk-management process. The project manager will be responsible for setting up an agenda and taking minutes/assigning action items.
This position works cross-functionally, representing TM, Toxicology, CP, and RA functions on project teams, and to stakeholders; Reports to the Senior Vice President & Head, Translational Medicine, Clinical Pharmacology, & Regulatory Affairs.
Duties and responsibilities
- Manages the deliverables in a matrix organization for the assigned TM, Toxicology, CP, and RA projects. Drives project timelines and actively manages budget for areas of responsibility. Provides support to functional leads in assessing resource needs to achieve project timelines and quality milestones.
- Ensures effective, accurate, and timely communication between the project team and TM, Toxicology, CP and RA functions, serving as a primary point of contact for TM, Toxicology, CP, RA project management related issues. Communication responsibilities include but are not limited to weekly/monthly project updates as well as project -specific program overview plans.
- Creates, maintain, and executes TM, Toxicology, CP and RA Project plans, timelines, agendas, resourcing requirements, rolling summaries, and baselining by using tools required to facilitate planning and coordination of deliverables for each assigned project.
- Facilitates the development of the integrated project plans for products in development and commercialization and ensures alignment across relevant functions and smooth transitions among pipeline stages. Facilitates contingency and risk mitigation planning.
- Proactively identifies issues and provides general guidance to resolve TM, Toxicology, CP & RA project issues and develops solutions to meet productivity and quality milestones and objectives. Works with the supervisor to identify and resolve any team or vendor performance issues.
- Develops tools and mechanisms for monitoring progress and problem solving within and outside TM, Toxicology, CP and RA functions. Defines and documents best practices that can be used across projects to ensure that all products are provided efficiently and with high quality.
- Interacts with Sr. Management and the Program Management function. Exercises judgment and exerts influence on the overall objectives and long-range goals of the function. Represents the TM, Toxicology, CP and RA functions in relevant internal/external committees.
- Leads special projects as assigned by supervisor/department management.
Special knowledge and skills needed
- Good knowledge of pharmaceutical drug development acquired by working in suitable pharmaceutical and/or biotechnology companies
- Ample experience within a GLP & GCP environment with a firm understanding of industry regulations, regulatory guidance, and best practices
- Ability to understand and interpret complex scientific issues across multiple projects as it relates to problem solving and strategy.
- Comprehensive knowledge of the cross-functional, drug development process, with a focus on IND and New Drug Application (NDA) processes
- Excellent verbal and written communication and skills.
- Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
- Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
- Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects in development and on market
- Experience in working with nonclinical toxicology, clinical pharmacology, clinical and regulatory functions as it pertains to drug development.
Education and experience
- Minimally requires Bachelor’s degree in any physical or biological science and at least 10 years of overall biotechnology/pharmaceutical industry related experience, with 5+ years of related toxicology, clinical pharmacology, regulatory affairs or overall project management experience. An advanced degree, MS or PhD, is a strong advantage. PMP certification is a plus.
Your Path to Endless Opportunities
If you’re looking to push the envelope and join an innovative company where technology meets drug discovery and development and you’re enthusiastic, creative, with a passion for cutting-edge research, you should join our team! We are looking for highly motivated, passionate employees to help us drive technology solutions for discovering breakthrough treatments for our portfolio of oncology and neuroscience programs, as well as for our partners across major therapeutic areas.
About BioXcel Therapeutics, Inc.
BioXcel Therapeutics, Inc. is a commercial-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology. The Company’s drug re-innovation approach leverages existing approved drugs and/or clinically validated product candidates together with big data and proprietary machine learning algorithms to identify new therapeutic indices. The Company’s commercial product, IGALMI™ (developed as BXCL501) is a proprietary, sublingual film formulation of dexmedetomidine approved by the FDA for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults. The safety and effectiveness of IGALMI has not been established beyond 24 hours from the first dose. BXCL501 is also being evaluated for the acute treatment of agitation associated with Alzheimer’s disease, and as an adjunctive treatment for major depressive disorder. The Company is also developing BXCL502 as a potential therapy for chronic agitation in dementia and, under its subsidiary OnkosXcel Therapeutics, BXCL701, an investigational, orally administered, systemic innate immunity activator for the treatment of aggressive forms of prostate cancer and advanced solid tumors that are refractory or treatment naïve to checkpoint inhibitors. For more information, please visit www.bioxceltherapeutics.com.
BioXcel Therapeutics is an Equal Opportunity Employer. All qualified candidates will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, gender identity, sexual orientation or protected veteran status.