Avetix Bio
Direct message the job poster from Avetix Bio
The SVP of Clinical Development will be a key member of the leadership team and will be responsible for asset and indication strategy, clinical trial strategy, execution, and analysis of all data. Along with this, the SVP of Clinical Development will support and build the clinical development team which includes medical leads, medical directors, and clinical research scientists who will be responsible for designing and monitoring assigned trials. This individual will work across the organization working with the PV, Regulatory, QA, Commercial, Medical Affairs, Business Development, Data management and Clinical Operations.
Reporting to our Chief Medical Officer you will positively impact patients’ when you:
Responsibilities
Provide strategic input to portfolio management and prioritization Serve as the key partner and contributor for the strategic planning, support early and translational development; and prepare specific strategic plans and initiatives. Closely collaborate with the Medical Director and Scientists in the development of new strategic options for assets in late development. Participates in the development of Study Protocols, Investigator's Brochures, DSURs, publications, presentations and other key documents in conjunction with other line functions and with minimal guidance. Participates in cross-functional teams, as needed, for assigned trials, working with other team members to achieve efficient, high-quality study execution. Reviews and may participate in the preparation of regulatory documents in support of regulatory submissions, including clinical section of INDs and CTAs, IND safety reports and annual reports for assigned trials, responses to regulatory authorities and Ethics Committees/IRBs, and other documents as appropriate. Candidate Profile & Requirements
Minimum of 15 years clinical research experience in an academic or industrial setting, with experience in analysis of research data and publications. Ability to work across multiple clinical programs and disease states Hands-on experience working with the FDA and other regulatory agencies on registrational studies, and post-approval activities Pharmaceutical/Biotech industry experience, including time managing clinical trials and/or clinical development program(s) Seniority level
Executive Employment type
Full-time Job function
Science, Project Management, and Business Development Industries
Biotechnology Research and Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Avetix Bio by 2x Get notified about new Vice President Clinical Development jobs in
Boston, MA . We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr
Provide strategic input to portfolio management and prioritization Serve as the key partner and contributor for the strategic planning, support early and translational development; and prepare specific strategic plans and initiatives. Closely collaborate with the Medical Director and Scientists in the development of new strategic options for assets in late development. Participates in the development of Study Protocols, Investigator's Brochures, DSURs, publications, presentations and other key documents in conjunction with other line functions and with minimal guidance. Participates in cross-functional teams, as needed, for assigned trials, working with other team members to achieve efficient, high-quality study execution. Reviews and may participate in the preparation of regulatory documents in support of regulatory submissions, including clinical section of INDs and CTAs, IND safety reports and annual reports for assigned trials, responses to regulatory authorities and Ethics Committees/IRBs, and other documents as appropriate. Candidate Profile & Requirements
Minimum of 15 years clinical research experience in an academic or industrial setting, with experience in analysis of research data and publications. Ability to work across multiple clinical programs and disease states Hands-on experience working with the FDA and other regulatory agencies on registrational studies, and post-approval activities Pharmaceutical/Biotech industry experience, including time managing clinical trials and/or clinical development program(s) Seniority level
Executive Employment type
Full-time Job function
Science, Project Management, and Business Development Industries
Biotechnology Research and Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Avetix Bio by 2x Get notified about new Vice President Clinical Development jobs in
Boston, MA . We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr