Early Development Program Leader (F/M)
DOMAIN THERAPEUTICS is a biopharmaceutical company that leverages its deep understanding of tumor immunology and immunosuppressive pathways to design new product candidates with the potential to restore the immune response against cancer.
DOMAIN THERAPEUTICS is dedicated to the discovery and development of new drug candidates targeting specifically G Protein Coupled Receptors (GPCRs), one of the most important classes of drug targets.
Located in the heart of the Strasbourg Innovation Park (Illkirch), France, DOMAIN THERAPEUTICS invites you to join a growing structure, within a young and dynamic team, where your involvement will be valued!
In its strategy of innovation and the development of a portfolio of projects in Immuno-Oncology, DOMAIN THERAPEUTICS is enthusiastic to welcome his/her Early Development Program Leader.
Reporting directly to the Director of development, you will interact transversally with Scientific Departments, R&D project managers, Laboratory managers and technical staff.
In order to carry out your mission you will have to :
- Be responsible for the success of a program from development candidate stage to phase II proof-of-concept
- Understand disease area (biology, trends, competition) and the drug development process and challenges to create a vision for the asset, then design a development strategy and set the goals/direction for the program
- Lead the multi-discipline activities (translational research, CMC, non-clinical safety, regulatory, clinical trials) to drive program deliverables and meet program milestones
- Liaise with discovery research to facilitate translational research from preclinical into clinical development
- Identify, select and oversee CDMOs and CROs that will conduct IND-enabling studies, first-in-human and proof-of-concept trials
- Establish a network of consultants/experts in early drug development related activities to advise and to solve specific issues
- Plan and manage the program timelines and budget while ensuring the quality of the data generated
- Identify and anticipate challenges, develop risk management and mitigation planning
- Drive effective resolution of program issues and communicate with executive leadership regarding proposed solutions
- Represent the program at external stakeholder meetings/conferences
- Organize advisory boards with key opinion leaders when needed
- Support business development discussions and contribute to fund raising activities
- Advanced degree in a scientific discipline (PhD, PharmD or equivalent)
- Minimum of 5 years of biotech/pharma industry experience in drug process in the early development space (from drug candidate to phase 2) in immune-oncology
- Record of accomplishment in the field of monoclonal antibody development
- Ability to create a clear purpose, global vision and a strategy for an early clinical phase asset
- Working knowledge of all functional areas of early development activities that include translational research, safety assessment, CMC, regulatory, clinical operations, clinical pharmacology and program management
- Strong capacity at managing and mobilizing multiple external partners/service providers involved in the program
- Understanding of scientific concepts and experience in translational research and biomarker development
- Familiarity with regulatory pathways and interactions such as scientific advice meetings at EMA or FDA
- Clinical experience in managing Phase 1/2 studies in immune-oncology is desirable
- Ability to work independently and to adapt to rapidly evolving situations and needs
- Strong commitment to delivering high-quality work
- Excellent oral and written communication skills
- Willingness to join an innovative, scientifically driven and fast paced biotech.
- Do you have good analytical and problem-solving skills and are you proactive ?
- Are you a force for proposals and able to take initiatives ?
- Are you organized, versatile and have a strong sense of priorities ?
- Are you enthusiastic, committed, and reliable ?
- Are you equipped with a strong ability to adapt, and know how to manage many tasks simultaneously ?
- Are you autonomous, and able to work transversely with other teams ?
- Do you have real communication skills with business acumen?
… then your profile interests us !
→ Permanent position / Full Time
→ Day Package
→ Salary to be determined + many advantages (lunch voucher, Holiday vouchers, leisure bonus, 13th month bonus, health insurance, etc …)
→ Contract start date to be agreed
NEXT STEP IS YOURS
Domain Therapeutics offers you an opportunity to put your skills to good use in a human and caring work environment… Tempted ? Don’t hesitate, join the Domain Therapeutics adventure !