Senior Manager/Director Clinical Operations

Logoslabs; San Francisco (CA); Teletrabalho; USD 180 000 - 240 000; Tempo integral

Resumo da oferta

Logoslabs is seeking a Senior Manager/Director of Clinical Operations to oversee up to two early-phase clinical programs in collaboration with the selected CRO. You will develop strategic operational plans, manage budgets, and guide vendors to ensure on-time, compliant study delivery.

The role requires leadership, strong regulatory knowledge (FDA/ICH GCP), and the ability to build a high-performing team across internal staff and external partners.

Qualificações

• Bachelor's degree required; MS/PhD/PharmD/MD or related advanced degree strongly preferred.
• Minimum 7 years for manager and 12 years for director level in clinical operations.
• Flexible, collaborative leader; benefits from consensus-driven teamwork.

Responsabilidades

• Create and execute clinical operational strategic plans aligned with product strategy and resources.
• Develop study feasibility, cost estimates, input into contracts, and support outsourcing.
• Track study finances, accruals, and approve related invoices.
• Lead and mentor internal staff and vendors; optimize department efficiency.
• Develop and ensure SOPs and guidelines comply with FDA regulations and ICH GCP.
• Oversee relationships with CROs, vendors, and investigative sites.
• Participate in clinical operations and study team meetings.
• Maintain up-to-date knowledge of clinical literature and regulatory practices.
• Remote role with potential travel to corporate HQ up to 2 times per year.
• Travel to clinical sites or CROs as needed to support trials.

Conhecimentos

Leadership

Stakeholder management

Clinical operations

Budget/finances

Vendor management

Strategic planning

Travel readiness

Formação académica

Bachelor's degree

Advanced degree preferred

Descrição da oferta de emprego

Position Summary

The Senior Manager/Director Clinical Operations will be responsible for oversight and management of up to 2 early phase clinical programs in collaboration with the selected Clinical Research Organization (CRO).

Primary Responsibilities:

• Create and execute clinical operational strategic plans in line with product strategy and resource allocation.

• Develop study feasibility, cost estimates, input into contracts, work/change orders and analyze tools and processes to support outsourcing efforts.

• Track clinical program study finances and monthly accruals and review/approve associated clinical site and vendor invoices.

• Build, develop and train internal staff and external vendors, structure department for enhancing efficiency, and create a highly engaged work environment for attracting and retaining highly qualified clinical operations professionals.

• Develop and ensure compliance with SOPs and guidelines, FDA regulations and current ICH GCP guidelines.

• Oversee and maintain the relationships with Contract Research Organizations, vendors, and investigative sites.

• Participate on clinical operations and study team meetings.

• Maintain a high level of professional expertise through familiarity of clinical literature, knowledge of therapeutic area, current medical practice and pharmaceutical regulations.

Additional Expectations

• Although a remote position, it may be necessary to travel to corporate headquarters up to 2 times per year.

• Ability to travel to clinical sites or to the CRO, as necessary to support trial management.

Qualifications:

• B.A/B.S required; M.S., PhD, PharmD, MD or other related advanced scientific degree strongly preferred.

• Minimum of 7 years for manager and 12 years for director level with progressive advancement within clinical operations in the pharmaceutical/biotech industry.

• Flexible and dynamic interpersonal approach, entrepreneurial by nature, a collaborative team player who works well with physicians, scientists, managers, peers, and staff.

• Ability to manage in a consensus environment through teamwork, trust and shared expectations, influencing strategic direction of complex global clinical operations issues, solicit information, listen well, persuade others, make important decisions and shape outcomes.