Director, Study Management/Clinical Operations, Cardio-Renal-Metabolism (On-site/Hybrid)

BioCT Innovation Commons; Ridgefield (CT); Hybrid; USD 220,000 - 350,000; Full time

Job summary

An established industry player is seeking a Director of Study Management/Clinical Operations to lead clinical trials and ensure compliance with regulatory standards. This role involves strategic leadership, team management, and collaboration with stakeholders to drive excellence in trial execution. The ideal candidate will possess extensive experience in the pharmaceutical industry and a strong background in clinical trial management. Join this innovative firm and contribute to impactful projects that enhance patient care while enjoying a supportive work environment that values work-life balance and professional growth.

Benefits

Competitive compensation

Performance-based bonuses

Health benefits

Work-life balance initiatives

Qualifications

• 10+ years in scientific, clinical, or medical fields with 6+ years in the Pharmaceutical industry.
• Expertise in clinical trial conduct and regulatory compliance.

Responsibilities

• Lead planning, execution, and reporting of clinical trials.
• Manage team performance and resolve operational issues.

Skills

Leadership

Problem-solving

Communication

Decision-making

Customer service

Education

Bachelor's degree

Advanced science/clinical degree (PharmD, M.D., DNP, DO, Ph.D., Master’s)

Tools

Relevant software applications

Job description

The Director, Study Management/Clinical Operations role is an On-site/Hybrid role, meaning it will be required to work from the Ridgefield, CT site 2-3 days per week.

The Director, Study Management/Clinical Operations is responsible for leading and supporting the planning, execution, and reporting of clinical trials within the assigned therapeutic area/s. They ensure compliance with regulatory and legal requirements, prioritize quality, patient safety, and data integrity, while embracing innovative technologies. The Director also manages the professional development and performance of the team, oversees trial and department budget, and resolves any operational issues that may arise. They are responsible for stakeholder management and providing critical trial updates cross-functionally and to senior management, while creating and maintaining a culture that drives empowerment, smart risk taking and one common CD&O identity.

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

Duties & Responsibilities

• Ensure excellence in trial planning, design, and execution.
• Evaluate data objectively and make data-driven decisions.
• Steer team delivery of pipeline commitments and maximize value for patients.
• Oversee optimal planning, resourcing, execution, and delivery of clinical trials.
• Participate in strategic meetings and represent the Clinical Development & Operations (CD&O) department.
• Collaborate with stakeholders and resolve operational challenges.
• Manage resources within the assigned group and across the entire TA portfolio.
• Cross-functional cooperation within and across departments in the key activities of audits (internal and external), inspections (sponsor/site) and joint initiatives.
• Foster a customer-focused culture and maintain strong stakeholder alignment.
• Build and maintain strong relationships with internal and external partners.
• Drive continuous process improvement and stay updated on industry best practices.
• Provide strategic leadership to Clinical Trial Managers and Clinical Trial Leaders and establish a performance-based team culture with accountability and a sense of urgency by effective recruitment, coaching, development, and performance monitoring.

Requirements

• Minimum of Bachelor's degree required; Advanced science/clinical degree (PharmD, M.D., DNP, DO, Ph.D., Master’s), preferred.
• Minimum of 10 years professional experience in a scientific, clinical, and/or medical space.
• Minimum of 6 years direct Pharmaceutical industry experience.
• Demonstrated expertise in clinical trial conduct and regulatory compliance.
• Previous experience directly leading people and/or leading project teams is highly preferred.
• Strong problem-solving and decision-making skills.
• Excellent customer service, communication, and leadership abilities.
• Proficiency in relevant software applications.
• Experience in conducting large-scale multinational clinical trials.
• Knowledge of drug development phases and federal regulations.
• Ability and willingness to travel domestically and internationally (10-20% of time).

Eligibility Requirements:

• Must be legally authorized to work in the United States without restriction.
• Must be willing to take a drug test and post-offer physical (if required).
• Must be 18 years of age or older.

Compensation

This position offers a base salary typically between $220,000 and $350,000. The position may be eligible for a role specific variable or performance-based bonus and or other compensation elements. For an overview of our benefits please click here.