Vice President, Clinical Operations

The Vice President, Clinical Operations leads a team of operations professionals (Trial Operations, Statisticians, Programmers and Data Managers) and is responsible for overseeing and executing the clinical development strategy and associated operational deliverables of global clinical trials (phase 1- 3, and post-marketing). The role provides leadership by defining and driving global organizational strategies and ensured strategic operational planning, optimal trial resource allocation (including consultants and vendor partners), as well as high quality execution of clinical trials around the globe within agreed clinical program timelines and budget. The role oversees the strategic prioritization of activities and deliverables, in accordance with overall corporate and development objectives, goals and timelines. The role successfully collaborates across the organization including Medical Affairs, Regulatory, Quality Assurance, Business Development, Finance, and Legal as well as external partners and others. This position reports to the Chief Medical Officer.

Responsibilities

• Hires, leads, and inspires a strong team responsible for the functional areas of trial operations and biometrics.
• Provides direction and mentorship to staff including setting goals that are aligned with both corporate and department goals.
• Ensures strong, collaborative partnerships with internal APT functions as well as external vendor partners.
• Develops and delivers operational excellence throughout the operations function and APT.
• Accurately estimates resources (budget and additional support staff) required for implementing and reporting clinical and medical studies.
• Contributes to strategic planning to optimize clinical development plans and ongoing data generation for APT assets and programs.
• Oversees all phases of clinical trials, meeting development objective deliverables.
• Provides direction and leadership for CRO and vendor selection, management, and oversight, including budget negotiation and performance.
• Provides technical expertise for the trial conduct, oversight, and reporting as well as development of documents (Protocols, Monitoring Plans, SAPs, Clinical Study Reports, Investigator Brochures, etc.).
• Key member of cross functional teams contributing to the strategy, messaging, and authoring as well as ensuring delivery of submission documents.
• Participates in interactions with regulatory authorities.
• Responsible for Clinical Operations budget forecasting and management as well as overall delivery to timelines.
• Proactively identifies, mitigates, and manages risk around global trial operations issues including implementation of risk-based assessment and approach.
• Oversees and contributes to the analysis, review, interpretation, and reporting of data, including support of publications.
• Oversees the preparation, review, and revisions of Clinical Development SOPs in partnership with Quality Assurance to assure compliance with GCP requirements and regulations while ensuring inspection readiness.
• Participates in the evaluation of diligence opportunities providing technical feedback on development plans, data, risks, probability of success, costs, and resource needs to bring potential products to market.

Qualifications

• Master's Degree in medical-related field or life sciences required; advanced degree preferred
• Minimum of 20+ years related experience in the Pharmaceutical or Biotechnology Industry.
• Expertise in the areas of Drug Development, Operations and Strategic Planning, specifically Management of Clinical Trial Operations.
• Extensive experience in GCP Compliance with a strong understanding of FDA regulations; EU Clinical Trials Directive, GCP and/ SOPs in pharmaceutical, or biotech environment, required.
• Extensive experience managing CRO's, Central Laboratories and other Clinical Study Vendors, including development and implementation of risk mitigation strategies and forecasts/budgets.
• Experience in Marketing Application Review and Submission.
• Demonstrated and effective leadership skills and proven ability to foster team productivity and cohesiveness.
• Demonstrated experience managing and mentoring Clinical Team members.
• Demonstrated abilities in decision making, evaluating, and solving complex problems, and affecting change.
• Excellent written and verbal communication skills.
• Strong problem resolution and conflict management skills.
• Ability to effectively multi-task and prioritize with strong organizational skills.

Compensation: Salary is industry-standard and is commensurate with experience

APT is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. APT seeks to diversify its work force and is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. At APT, we don't just accept difference — we celebrate it, we support it, and we thrive on it for the benefit of our employees, our therapeutics, and our community.

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