Vice President of Clinical Development Operations

Company Overview

Strand Therapeutics is a clinical stage biotechnology company utilizing synthetic biology to genetically program mRNA to deliver truly revolutionary immunotherapies to patients. Building on the idea of creating smart therapies based on Boolean logic circuits, Strand was started by biological engineers working together at MIT who were seeking to apply the concept of the emerging field of mRNA therapeutics. Strand's technology is therapeutic‑area and mRNA modality agnostic where therapeutic proteins are encoded onto modified, self‑replicating, or circular mRNA backbones which in turn are programmed with cell‑specific sensors and circuits.

Today, Strand has established multiple programmable mRNA platforms with one clinical stage asset and several programs in preclinical development as well as early discovery. Our lead program, STX‑001, is currently being evaluated in a Phase 1 clinical trial for solid tumors. Our corporate headquarters is located in the Fenway district of Boston, Massachusetts.

Strand is looking to build a team that understands the value of working at a start‑up. Joining Strand now places you alongside the founding executive team and world‑leading advisors. We are looking for people who have the enthusiasm and motivation to be a highly contributing member of a small but extremely productive team. This opportunity will offer the employee the ability to work closely with the founding team and be a part of the growth strategy of the company.

We are looking for a highly motivated and enthusiastic leader for the role of Vice President of Clinical Development Operations. Reporting to the Chief Medical Officer, the Vice President of Clinical Development Operations will lead all clinical trial activities and operations for the organization. This individual will drive all trial activities for our 2 clinical stage programs as well as support the planning and development of other company programs as they advance throughout pre‑clinical development into first‑in‑human clinical trials.

This will also be an opportunity to work closely with various cross‑functional teams internally and externally to prepare for regulatory interactions and drive the development of our programs forward.

• Serve as the clinical operations expert for all clinical stage and preclinical stage programs for the company.
• Accountable for delivery of assigned clinical program/trial budgets, managing study timelines, and resource management with focus on quality, including making recommendations and decisions regarding operational strategies to support study and/or program objectives
• Develop operational strategy and clinical operations plans in support of execution of the Clinical Development Plan
• Develop clinical timelines, budget forecasts and ensure accountability for tracking and deliverables.
• Develop and maintain departmental resource and budget plans.
• Ensures oversight and study‑specific Risk Management Plans (RMP) (e.g., milestones, metrics, and critical path), ensuring appropriate escalation when required. Evaluate study-level issues for broader impact (e.g., cross‑study, cross‑program etc.) and ensure resolution
• Partner and collaborate with cross‑functional stakeholders, external consultants, and other relevant stakeholders
• Lead and oversee execution of clinical trials in compliance with ICH/GCP, local regulations, and Strand Therapeutics' SOPs to ensure quality and data integrity
• Support the selection, oversight, and management of CROs and other vendors including financial aspects of the partnerships.
• Oversee site feasibility/capability assessments in collaboration with the CRO and cross‑functional team.
• Develop site recruitment, enrollment, and engagement strategies for all clinical trials
• Review and provide clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports and other documents and plans as appropriate
• Manage and provide oversight to the cross functional teams and CRO/vendor(s) related to all aspects of clinical trial operations
• Responsibl…