Description:

The Associate Director, Clinical Operations is responsible for oversight of US clinical development providing vision, leadership, and mentoring of staff. The Associate Director is also a valuable team member providing input into clinical trial implementation, execution, and outcome, building consensus within the global clinical operations team. The Associate Director is also responsible for the day-to-day operations management of clinical trials. This position is also charged with the management of internal staff and external vendors and contractors.

o Contribute to strategic planning to ensure optimized clinical development plans

o Acquire knowledge of the therapeutic area and products

o Comprehensive understanding of ICH/GCP requirements, principles, concepts, industry

practices and standards

o Participate directly in all study activities, including protocol review, development of study

materials, clinical trial site selection and interaction, contractor and CRO selection and

management and safety reporting

o Responsible for departmental resource management, budgets, benchmarking, metrics,

performance reviews and establishing standards operating procedures and guidelines

o Regularly interact with upper management in a global setting

o Develop, manage, and adhere to annual departmental budget

o Manage clinical staff (SR. and JR. CRAs, Clinical leaders, Admin, etc.)

o Provide training and mentoring, and ensure fulfillment of responsibilities in accordance with

regulations, company policies, and procedures

o Ensure successful execution of projects according to regulatory guidelines, provide technical

leadership, and facilitate effective internal and external relationships (e.g., key investigators,

opinion leaders, and other industry leaders)

o Provide technical direction in CRO and vendor selection and management

o Conduct performance appraisals as assigned. Provide measurable feedback to managed

staff and outlines actions for improved performance. Formulates and implements employee

corrective actions as needed

o Working knowledge of data management, data review, analysis, and regulatory submissions

o Assess staffing requirements and fill open positions with qualified candidates

o Provide leadership through effective objective setting, delegation, communication, and role

modeling

o Provide technical training and mentorship for the development of clinical documents

(protocols, monitoring plans, clinical trail reports, investigator brochures, and trial conduct)

o Manage adverse event review process with medical monitor and drug safety unit to ensure

accuracy and completeness

o Participates in development of study protocols, integrated clinical study reports, and IND

annual reports

o Take a lead role in presenting data at investigator meetings

o Cooperate in interdisciplinary teams (Corporate Clinical R&D, Regulatory, Medical Affairs) and

ensures that timelines are met, conflicts resolved, and projects are kept on time and within

budget

o Perform other reasonable duties as assigned by the Senior Director, Clinical Operations

Additional Skills & Qualifications:

o BS/BA or higher, preferably in a healthcare or life science discipline

o Advanced degree preferred

o 6 years of clinical, drug, or biologics development in the pharmaceutical or biotech industry

o Additional healthcare, life science experience is beneficial

o Expertise in clinical drug development, operations, and strategic planning, specifically

management of clinical trials operations

o Demonstrated experience in managing and mentoring of clinical team members

Experience Level:

Expert Level

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.