Director of Research Operations in Leipzig/ Germany
Heat Biologics, USA
Heat Biologics (www.heatbio.com) is a clinical-stage immunotherapy company focused on developing novel, off-the-shelf drugs to combat a wide range of cancers and viral infections. Heat’s proprietary allogeneic vaccine platform exploits the natural ability of diseased cells to activate the immune system and amplifies the body’s natural defenses. The company is currently in Phase II clinical trials with its lead product and has a robust pipeline of products in various stages of testing. Heat Biologics is based in North Carolina, USA, and is opening a Leipzig subsidiary company to support our collaboration with the Fraunhofer Institute for Cell Therapy and Immunology and to progress development and testing of innovative vaccines based on Heat’s vaccine platform technology.
We are seeking a Director of Research Operations. The Director will plan, direct, and manage the research and operational affairs of Heat Biologics’ project/product teams in Germany under the leadership of the General Manager. The Director will be a key interface between Heat’s US office and collaborators at the Fraunhofer Institute. The Director will communicate with funding agencies, the Paul-Ehrlich Institute, and product/project teams. The Director will be responsible for supervision of project progress and budget utilization, will generate progress reports, and will prepare communications for diligence activities and regulatory agents. The Director will provide support for both research and commercial activities in Germany and will also participate in sourcing of new funding opportunities, conducting market research analysis, and interfacing with CROs and consulting firms.
Tasks:
- Acting as a liaison between Heat Biologics and the Fraunhofer Institute for Cell Therapy and Immunology.
- Oversight of grant proposals to funding agencies. This includes but is not limited to opportunity identification and assessment, grant writing, proposal delivery and reporting, communication with researchers, program officers, and regulatory agencies.
- Oversight of research project planning and execution. Establishing and setting project timelines, milestones and action items, determining project resources, identifying operational issues and facilitating their resolution.
- Developing internal and external status reports. Will be involved in the preparation of clinical trial reports and development of regulatory documents including INDs, IND annual updates, briefing documents, CTAs, and regulatory meeting briefing documents.
- Working with the General Manager to plan and direct project and personnel schedules and to monitor budgets and spending.
- Developing presentation materials and documentation to support business growth and commercialization activities.
Qualifications:
- Advanced degree (PhD or MD) with experience in immunology, oncology, or a relevant area of the biological sciences. The ideal candidate will be familiar with the action of immunotherapeutic drugs and will be able to contribute to development of our unique technology platform. Will consider direct relevant experience plus a bachelor’s degree in the sciences in lieu of advanced degree.
- Superior verbal and written communication and interpersonal skills, including a positive and professional attitude to tasks and projects.
- Adept at handing multiple projects and tight deadlines in an extremely fast-paced work environment with little direct supervision.
- Strong project management skills, ability to persuade and motivate others.
- Ability to prepare and present research updates to senior management and collaborators, as well as regulatory and funding agencies.
- Proven track record of success in project management, ideally in the pharmaceutical, biotech or healthcare industries
- Fluency in both English and German (additional languages a plus).
Contact
Please send cover letter, resume or CV, and salary requirements to ccostantino [at] heatbio.com