Vice President of Clinical Development Operations

Strand Therapeutics•Boston, MA

9d•$316,000 - $356,000

About The Position

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.

Requirements

15+ years of clinical trial operations experience in biotech; Experience working in a smaller, fast paced environment highly preferred with 5+ in management or leadership roles.
Experience running oncology trials required.
Experience in and understanding of end-to-end management of clinical trial conduct, the pharmaceutical industry, clinical drug development, clinical trials operations and regulatory components is essential.
Experience with all aspects of clinical trial management including streamlining operational activities of trial protocols and ensuring deliverables are attained in a timely manner.
Proven success participating in cross-departmental clinical strategy, planning and implementation activities. (Departments include executive leadership, regulatory, QA, CMC, translational development, program management, finance, business development, medical affairs and medical writing).
Extensive experience with the identification, negotiation, management, and oversight of external vendor partnerships, such as CROs, for monitoring, database management, statistics, and safety reporting.
Experience building an internal clinical program management function, managing a team of employees and consultants as well as hiring internal stakeholders to support trial needs and leveraging external consultants as needed.
Experience interacting with domestic health authorities, such as the FDA, required

Nice To Haves

Experience with regulatory submissions, including INDs, NDAs and BLAs highly preferred.
Experience interacting with global regulatory health authorities, such as the EMA, PMDA, and/or Australian CTN is a plus.
Strong interpersonal skills with the ability to interact and communicate effectively with individuals from multiple departments at all levels of the organization.
Strong organizational and time management skills.
Strand offers a fast-paced, entrepreneurial, team-focused small company environment.

Responsibilities

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.
Develops 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
Responsible for representing Clinical Operations on cross-functional project teams and vendor/CRO operational meetings and ensuring compliance with operational standards and procedures.
Manages content, agenda, and discussions at clinical operations sub-teams and ensures action items are closed
Along with other Clinical Development personnel, represent Strand Therapeutics externally to Investigators, site staff, and Key Opinion Leaders
Perform and document study level Sponsor Oversight of outsourced clinical activities
Communicate study-status, cost, and issues to ensure timely decision-making by senior management
Oversee/collaborate with Clinical Quality Assurance on and contribute to inspection readiness activities that support audits and regulatory inspections related to clinical trial conduct
Maintain oversight and participate in the creation/review/training/maintenance of departmental and organizational SOPs to ensure compliance
Lead and/or participate in clinical operations workstreams related to departmental and operating model related initiatives
Develop and foster strong, collaborative relationships with key stakeholders both within and external to Strand Therapeutics
Provide oversight and mentorship to assigned Clinical Operations staff by providing clinical operations/functional area expertise and support identification and prioritization of study and program level work. Will have direct line management of Clinical Operations staff.
Strive for continuous improvement and more efficient ways of working in clinical operations
Supervise Clinical Operations Team (CTMs, CRAs, CTAs, etc.) and ensure team member’s adherence to the regulatory requirements, ICH-GCP guidelines, and other relevant procedures.
Participate in the design, development and review of clinical trial protocols and study-specific documents, e.g., informed consent forms, study guidelines, operations manuals, oversight plans, process developments (including Trial RACI).
Keep up to date with industry practice and communicate key messages back to Strand Therapeutics, providing recommendation accordingly.