Executive Director, Business Excellence - US Biomedicine - Remote *PC 1474

Miltenyi Biotec Inc; Boston (MA); Remote; USD 120,000 - 180,000; Full time

Job summary

An established industry player is seeking a dynamic leader to drive operational excellence and strategic alignment for the launch of a groundbreaking CAR T-cell therapy. This pivotal role involves overseeing cross-functional teams, ensuring compliance, and optimizing business operations to support long-term success. The ideal candidate will have extensive experience in the biopharmaceutical sector, particularly in managing complex therapies. Join a passionate team dedicated to revolutionizing biomedical research and making a real impact on patient care.

Qualifications

• 12+ years of leadership experience in biopharmaceutical operations.
• Proven track record in managing operational readiness for product launches.

Responsibilities

• Drive strategic alignment across U.S. functional teams for operational efficiency.
• Lead cross-functional launch planning and project management efforts.

Skills

Leadership in Business Operations

Project Management

Cross-Functional Collaboration

Data Analytics

Compliance Knowledge

Operational Excellence

Education

Bachelor's Degree

Advanced Degree (MBA, MPH, PharmD, PhD)

Tools

CRM Systems

Data Warehousing

Business Intelligence Tools

Job description

Description

Your Tasks:

This position will be responsible for driving strategic alignment and operational excellence across functional teams in the U.S. to support the successful launch and long-term commercialization of the company's first CAR T-cell therapy. This role will ensure efficient execution of key business processes, compliance, patient support operations, data approach, launch planning, and project management, while also serving as a bridge between U.S. teams and global functions. This individual will play a hands-on role in building and leading a high-performing team responsible for the implementation of the control tower system and processes, business intelligence capabilities, and execution of launch-critical operational initiatives, including promotional review, sponsorships, speaker bureau logistics, and congress planning. Beyond launch, this leader will be responsible for optimizing and evolving business operations to drive long-term efficiency, compliance, and scalability as the organization grows.

This position will report to the Chief Officer, North America Biomedicine.

Essential Duties and Responsibilities:

Strategic & Operational Excellence

• Ensure strategic alignment across U.S. functional teams (Commercial, Medical Affairs, Market Access, Manufacturing, Logistics, Compliance, IT, Legal, Finance) to drive operational efficiency and execution of business priorities.


• Serve as the central point of coordination between U.S. and global teams, ensuring alignment on CRM, data warehousing, and reporting needs.


• Implement and oversee the control tower system and processes to optimize patient support operations, compliance tracking, and real-time business intelligence.


• Lead cross-functional launch planning and project management efforts, ensuring all teams are aligned and meeting key milestones.


• Oversee the operational execution of the promotional review process, ensuring materials meet regulatory and legal compliance standards.


• Develop scalable operational frameworks to support the business beyond launch, ensuring continued process improvements and efficiencies.

Ensure seamless execution by providing oversight and strategic direction to direct reports across the following functional areas:

Organizational Alignment, Launch Excellence & Compliance

• Oversee the implementation of a comprehensive compliance program in collaboration with the Compliance Officer, ensuring adherence to regulatory and industry standards.


• Oversee the implementation of pricing and transparency reporting programs in collaboration with Legal & Finance, ensuring compliance with federal and state laws.


• Establish a cross-functional US Launch Team and lead the development and execution of a fully integrated plan to support the successful launch of a first CAR T for the company.


• Develop and monitor key performance indicators (KPIs) for launch readiness, ensuring teams meet critical milestones.

Patient & Logistics Operations

• Leading the design and implementation of the patient journey framework, ensuring seamless coordination between patient support services, manufacturing, and supply chain logistics.


• Integration of patient scheduling, manufacturing processes, and logistics operations to optimize chain-of-identity and chain-of-custody management.


• Development and oversight of the control tower system, enabling real-time tracking of patient movement, supply chain processes, and logistics performance.


• Collaboration with Manufacturing, Supply Chain, and Market Access teams to establish efficient workflows and ensure uninterrupted patient access to therapy.

Business Intelligence & Operational Excellence

• Leading efforts in data procurement, CRM/data warehousing, and analytics capabilities, ensuring alignment with global teams and U.S. commercial needs.


• Collaborating with Finance and IT to implement critical procurement processes, reconciliation processes, and system modifications to ensure compliant and efficient operations.


• Manage the promotional review process, sponsorship processing, speaker bureau logistics, and congress planning, ensuring regulatory compliance and operational efficiency.


• Support for treatment center onboarding, ensuring training, certification, and logistics integration are streamlined for launch.

Requirements:

• Bachelor's (BA/BS) degree required, advanced degree (MBA, MPH, PharmD, PhD) preferred; Minimum of twelve (12) years of progressive leadership experience in business operations, commercial excellence, or related leadership roles in the biopharmaceutical industry; or a combination of education and experience.


• Proven track record of leading operational readiness for launch, ideally in cell therapy, oncology, rare disease, or other complex therapies.


• Experience managing and overseeing cross-functional business operations.


• Expertise in business intelligence, data analytics, CRM systems, and operational infrastructure.


• Deep knowledge of compliance, patient services, logistics, and commercial operations in a highly regulated environment.


• Strong understanding of manufacturing and supply chain integration for complex therapies, including patient scheduling and logistics.


• Extensive experience across multiple functional areas within the pharmaceutical or biotech industry, such as sales, marketing, market access, commercial operations, patient services, supply chain, medical affairs, or compliance. A broad understanding of cross-functional alignment is highly desirable.


• Ability to travel domestically and internationally as required (5-10%)

Knowledge, Skills & Abilities

• Deep cross-functional understanding of U.S. and global pharmaceutical environment.


• Hands-on leader who can execute in the pre-launch phase and transition to strategic leadership post-launch.


• Ability to design and implement scalable processes to support launch and long-term commercialization.


• Deep understanding of U.S. healthcare regulations (FDA, OIG, PhRMA) and compliance best practices.


• Strong cross-functional collaboration, problem-solving, and leadership skills, with the ability to influence across all levels.


• Ability to navigate ambiguity, drive innovation, and execute in a fast-paced, high-growth environment.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to walk; use hands to finger, handle, or feel; reach with hands and arms, talk, and hear. The employee is required to stand; climb or balance and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception and ability to adjust focus. Must have ability to handle more than one task at a time and must work at a rapid pace while maintaining attention to detail.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. This job is performed in a variety of facilities. Each person performing this job must have a home office environment, which is temperature controlled. This job requires the person to be mobile to visit customer sites. Due to the travel requirements, this position may be exposed to natural elements of nature. Used research/clinical equipment may be handled in this job and strict SOPs and PPE must be worn.

Miltenyi Biomedicine, Inc. is an EO Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity

Miltenyi Biomedicine, Inc. participates in E-Verify.

Are you ready to start revolutionizing biomedical research? When you join Miltenyi Biotec, you join a family that is passionate about making a real impact - one breakthrough at a time. For over 30 years, we have played a pivotal role in the design, development, manufacture, and integration of products for sample preparation, cell separation, cell analysis, imaging, and cell culture needs. These developments have led to cutting-edge cell and gene therapies - transformative methods that mobilize the body's own cells and genetic blueprint to tackle diseases such as cancer and autoimmune conditions. Today, our more than 18,000 solutions play a vital role in paving the way for the medicine of tomorrow.

Equal Opportunity Employer

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