Job description
Join VitaNova Therapeutics as a Senior Clinical Research Director focused on specialized medicine and rare disease programs. You will lead cross-functional teams to design and execute adaptive trials, ensure regulatory readiness, and translate scientific insights into patient impact. This is an opportunity to shape the next generation of therapies at a fast-growing biotech in Boston.
We offer a premium compensation package, flexible work options, and a culture that rewards initiative, collaboration, and scientific excellence.
Responsibility
- Lead the planning, execution, and oversight of early- to late-stage clinical trials in specialized medicine, ensuring scientific rigor and patient safety.
- Direct cross-functional teams across Medical Affairs, Regulatory, Data Science, and Clinical Operations to meet program milestones.
- Develop and optimize trial design, endpoints, statistical analysis plans, and adaptive trial strategies in collaboration with statisticians.
- Ensure regulatory submissions and safety reporting meet global standards (FDA, EMA, etc.).
- Mentor and guide junior clinical operations staff, medical writers, and CRAs to build a high-performing team.
- Oversee vendor management, budgeting, and risk mitigation to ensure on-time delivery and quality.
Qualification
- MD or PhD in life sciences with 8+ years in clinical development or medical affairs, preferably in rare diseases or oncology.
- Proven track record leading global clinical trials and cross-functional teams.
- In-depth knowledge of regulatory requirements (FDA, EMA, ICH) and pharmacovigilance processes.
- Strong statistical understanding and experience with adaptive trial designs and endpoints selection.
- Excellent communication, negotiation, and leadership skills with ability to influence at executive levels.
- Experience with EDC systems, data standards (CDISC), and data privacy regulations (HIPAA, GDPR).
- Willingness to travel up to 25-30% for site monitoring and conferences.