SVP Clinical Development

Avetix Bio

Boston (MA)

On-site

USD 250,000 - 500,000

Full time

14 days+

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Job summary

A biotechnology company based in Boston, MA, seeks an experienced SVP of Clinical Development. This role involves strategic oversight of clinical trials, collaboration with cross-functional teams, and a strong focus on regulatory compliance. Ideal candidates will have over 15 years of clinical research experience and expertise in managing clinical development programs. This full-time position offers a pivotal role in impacting patient outcomes.

Qualifications

Minimum of 15 years clinical research experience in academic or industrial settings.
Hands-on experience with FDA and other regulatory agencies.
Pharmaceutical/Biotech industry experience managing clinical trials.

Responsibilities

Provide strategic input to portfolio management and prioritization.
Develop Study Protocols, Investigator's Brochures, and other key documents.
Collaborate with Medical Directors and Scientists on new strategic options.
Contribute to Study Protocols, Investigator's Brochures, DSURs, publications, and regulatory documents.
Participate in cross‑functional teams to ensure high‑quality study execution.
Support regulatory submissions and responses to authorities/IRBs as needed.

Skills

Clinical research

Regulatory submissions

Cross-functional collaboration

Strategic planning

Job description

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