Senior Director, Clinical Business Operations

Lantheus is headquartered in Bedford, Massachusetts with offices in Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio.

Lantheus is an entrepreneurial, agile, growing organization that provides innovative diagnostics, targeted therapeutics, and artificial intelligence (AI) solutions that empower clinicians to find, fight and follow disease. At Lantheus our purpose and values guide our behaviors in all interactions and play a vital role in creating a dynamic environment that contributes to our success. Every employee is crucial to our success; we respect one another and act as one knowing that someone's health is in our hands. We believe in helping people be their best and are seeking to bring together a diverse group of individuals with different viewpoints and skill sets to be a part of a productive and inclusive team.

Job Summary

We are looking for an enthusiastic self-starter who wants to join a fast-growing company with responsibility for establishing and leading the Clinical Business Operations (CBO) function. The CBO function will include strategic outsourcing, clinical finance, clinical operations site contracts, and vendor management. This is a strategic leadership role within the Development organization, reporting to the Vice President, Clinical Operations. The ideal candidate will possess expert insight and strong knowledge of best practices in strategic outsourcing, clinical finance, and vendor strategy, oversight, and relationship management. They will work cross-functionally with a variety of departments, including Finance, Accounting, Legal, IT, CMC, Regulatory, etc. and serve as Business Partner to the Vice President, Clinical Operations, Chief Medical Officer, and other Development department heads on a wide variety of tasks and analyses. The individual will play a key role in shaping the company's clinical business operations and outsourcing function and will build capabilities to meet future portfolio needs.

Key Responsibilities/Essential Functions

Strategic Outsourcing & Vendor Relationship Management:

• Establish the Clinical Business Operations function, including strategy and oversight for all CBO activities; Strategic Outsourcing, Vendor Strategy and Governance, Clinical Finance, Site Contracts/Budgets/Payments strategy and oversight, and other business-related support.
• Strategize the ideal approach to site contracting, budgeting, and payments for Lantheus, in partnership with Legal, Clinical Operations, and Finance. This may involve a combination of in-house and outsourced models.
• Drive cost savings and improve operating efficiency through innovative sourcing strategies and preferred partnership models for CROs and other high-spend or key vendors, including discount structures.
• Develop and manage governance structures to maintain transparency, accountability, and compliance with regulatory standards. This includes the establishment of partnership charters, Joint Operating (JOC) and/or Executive Steering Committees (ESC), escalation pathways, and key performance, quality, and risk indicators (KPI/KQI/KRI).
• Manage the end-to-end RFI/RFP process in collaboration with key stakeholders as needed, i.e., Clinical Operations, Regulatory, Data Management, Statistics, Medical, Finance, Legal, IT, and other key stakeholders.
• Lead negotiations and execute agreements, budgets, payment terms, and change orders to optimize vendor relationships, and maximize Lantheus' cash position.
• Drive a culture of innovation and operational excellence, ensuring the Clinical Business Operations function remains at the forefront of industry best practices and emerging trends.
• Inspire and mentor a team of clinical business operations managers (as the portfolio grows) to foster professional growth and excellence.
• Cultivate a collaborative, innovative, and results-driven culture aligned with Lantheus' core values.

Clinical Finance:

• Partner with Finance on a variety of clinical finance deliverables as needed, e.g., clinical trial budgeting, forecasting, long-range plan (LRP), accruals (vendor and site), and reporting with variance analysis and comments.
• Establish periodic meetings with high-spend vendors such as CROs, Finance, Accounting, and Clinical Operations, to ensure the accuracy of monthly and/or quarterly accrual estimates and review of out-of-scope expense items.

Other:

• Ability to hire, mentor, and inspire direct reports, as needed due to the growth of the clinical portfolio.
• Perform other related duties and ad hoc projects as required by the position.

Job Requirements:

• BS/BA degree in a scientific or business discipline (accounting or finance preferred), MBA highly preferred.
• Minimum 12+ years of experience in clinical business operations, strategic outsourcing, and finance within pharmaceutical and/or biotech companies.
• Extensive knowledge of the drug development process and regulatory requirements (ICH, GCP, 21 CFR Part 11).
• Excellent communication and presentation skills to effectively relay information across the organization, from study teams to the executive level.
• Excellent interpersonal skills to build strong and trusted relationships internally across functions, as well as with external vendors.
• Adaptable to changing priorities while effectively managing multiple commitments.
• Exceptional negotiation, analytical, and decision-making skills.
• Highly driven and self-motivated, with a commitment to the highest standards of ethics, honesty, and integrity.
• This position is site-based and requires a presence on-site of 3 days per week in Bedford, MA when not traveling.

Lantheus is an equal opportunity employer that provides a workplace free from discrimination. All qualified applicants and employees are considered without regard to race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any other characteristic protected by law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Lantheus Talent Acquisition team at talentacquisition@lantheus.com.