Senior Manager/Associate Director, Clinical Business Operations

Menarini Group; United States; Remote; USD 130,000 - 185,000; Full time

Job summary

An established industry player is seeking a Senior Manager/Associate Director for Clinical Business Operations. This strategic role will oversee the operational excellence of clinical trials, managing vendor relationships and ensuring compliance with contracts. The ideal candidate will have extensive experience in the pharmaceutical industry, particularly in clinical outsourcing and project management. Join a dynamic team dedicated to innovation and excellence in patient care, and help shape the future of oncology treatments. This position offers a competitive salary and a comprehensive benefits package, reflecting the organization's commitment to its employees.

Benefits

Short-Term Incentive Programs

Fidelity 401(k) with company match

Anthem Premier PPO and HDHP insurance plans

Company paid Basic Life & AD&D insurance

Pre-tax FSA/HSA programs

Qualifications

• 6+ years of experience in pharmaceutical industry with clinical outsourcing.
• Strong negotiation and project management skills required.

Responsibilities

• Drive operational excellence across clinical trials and manage vendor relations.
• Monitor vendor budgets and ensure compliance with contracts.

Skills

Negotiation Skills

Project Management

Data Analytics

Communication Skills

Relationship Building

Analytical Skills

Education

BA/BS or equivalent related work experience

Degree in healthcare, legal and/or finance

Tools

Microsoft Office Suite

Project Accounting Tool

Job description

Overview

Founded in 1886 in Naples under the name of Farmacia Internazionale, Menarini moved in 1915 to Florence where the Group’s headquarters are still located today. High quality therapeutics and diagnostics solutions for patients, ethics as our underlying principle, dedication to innovation and advancement, strong people centricity and environmental sustainability. These five pillars form the foundation of the Menarini Group, an Italian pharmaceutical company with nearly 135 years of history.

The Menarini Group is present in 140 countries around the world. Its companies span from Europe to Asia, to Africa and the Middle East, to Central America and to the United States where with the acquisition of Stemline Therapeutics, a NASDAQ-listed biopharmaceutical company, the company marked its entry into the US oncology market.

Thanks to the valuable contribution of around 18,000 employees, every year more than 500 million packs of drugs are produced at the Group's 18 manufacturing sites including a biotech plant for the manufacturing of monoclonal antibodies that also serves external clients distributed across 6 continents.

Menarini has made a strong commitment to oncology, investing in a pipeline of five investigational compounds for the treatment of a variety of hematological and solid tumors. The acquisition of Stemline Therapeutics in June 2020, further strengthened Menarini’s oncology portfolio, adding both commercial and clinical-stage assets. ELZONRIS (tagraxofusp) is a novel, first in class targeted therapy for patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN). To date, Elzonris is the only approved treatment for BPDCN in the U.S. and EU, and the first and only approved CD123-targeted therapy.

In January 2023, Stemline Therapeutics, received U.S. FDA approval for ORSERDU (elacestrant), the first and only treatment specifically indicated for postmenopausal women or adult men with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer. ORSERDU is the first endocrine innovation in more than 20 years, and specifically addresses a major unmet need.

Responsibilities

Opportunity

The Senior Manager/Associate Director, Clinical Business Operations is a strategic role within the R&D GCO organization, dedicated to driving operational excellence across clinical trials. This individual will act as a primary point of contact for all vendors and GCO business partners for their therapeutic & functional areas of support across the portfolio. They will collaborate with clinical program directors, clinical program leads, clinical trial leads, finance, procurement & strategic sourcing, legal, and other internal stakeholders to secure services for our clinical trials and drive the governance and overall management of their scope of work.

Responsibilities

• Influences and strategically manages the linkages between GCO across functional areas, including finance, project management, data management, PK, biostatistics, clinical development, medical affairs, regulatory, drug supply, pharmacovigilance, translational, CMC, and QA to drive the successful implementation of the outsourcing strategy for an assigned project or program.
• Work closely with Finance and clinical program team to closely monitor scope of work, vendor budgets, out-of-scope activities, accrued units or milestones, and tracking of vendor payments.
• Acts as the first line of contact for issue escalation related to contracts and budgets.
• Provides training of internal stakeholders on key contractual terms and obligations to ensure compliance and understanding as the business partners execute the work performed under the contract.
• May independently lead the RFP and RFI process, analyze supplier services, budgets and proposals, conduct bid defense meetings, award vendors, negotiate and execute complex agreements.
• Cultivate and maintain strategic partnerships with Contract Research Organizations (CROs) and other vendors to optimize timelines, budgets, and quality across the portfolio.
• Independently identifies, escalates and manages non-preferred provider vendor performance issues and develops and implements solutions to ensure overall performance, compliance, and quality.
• Partner with functional leaders to drive alignment across the clinical trial portfolio, ensuring strategic priorities are consistently met.
• Driving a culture of innovation and operational excellence, ensuring the clinical operations function remains at the forefront of industry’s best practices and emerging trends.
• Provide effective communication and recommendations to the business with support from the SME to ensure Menarini Stemline receives the best value for the contracted service.
• Actively monitors study progress for possible changes in study scope to ensure timely change order implementation and finalization utilizing advanced knowledge to drive the negotiation of the change orders and associated costs to minimize the risk to Menarini Stemline.
• May lead or contribute as a subject matter expert on key projects, initiatives, and committees including governance vendor meetings to identify and implement process improvements and standards while ensuring Menarini Stemline’s business needs and purchasing/compliance requirements are met.
• May oversee the selection, implementation, and management of key clinical technologies (e.g., project accounting tool).

Qualifications

Qualifications

• BA/BS or equivalent related work experience is required; Degree in healthcare, legal and/or finance preferred.
• Minimum 6 years of extensive experience in research, industry or legal setting with pharmaceutical industry experience in clinical outsourcing contracting or finance is required.
• Must have demonstrated ability in negotiation and project management skills with the ability to coordinate across projects/program/timelines. Must have superior written and oral communication skills, with the ability to convey overall engagement objectives and maintain open lines of communication between the internal stakeholders and the service providers.
• Ability to build internal and external relationships to effectively and independently provide leadership and mentor other team members to strategically drive the business and solve issues efficiently and mitigate risk.

Skill/Knowledge Requirements

• Proven experience selecting and managing, and overseeing CROs, vendors, and clinical trial consultants.
• Demonstrated expertise in forecasting, budgeting, data analytics, modeling, and process improvement design.
• Strong project management skills and the ability to lead cross-functional teams in a matrixed environment.
• Experience with technology implementation and operational transformation within clinical trials.
• Demonstrated success in scaling operations within a fast-paced, entrepreneurial biotech or pharmaceutical setting.
• Strong analytical skills with the ability to synthesize complex data and communicate actionable insights.
• Strong interpersonal skills with demonstrated ability to connect, collaborate and build relationships across all levels and functions and establish credibility with leaders and key external stakeholders.
• Strong oral and written communication skills with ability to communicate effectively at all levels and present complex and/or new ideas both internally and with external stakeholders.
• Extensive knowledge of GCP and ICH principles of clinical trial conduct.
• Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint).

Please note--this position is classified as a corporate office position. In accordance with the New York employer convenience rule, Stemline will withhold New York state income taxes for all corporate office employees, regardless of whether these employees work in New York or remotely.

Base Salary Range of $130,000-$185,000. Menarini Stemline offers generous compensation and benefits packages, including Short-Term Incentive Programs, Fidelity 401(k) (with company match), Anthem Premier PPO and HDHP insurance plans, Company paid Basic Life & AD&D insurance and pre-tax FSA/HSA programs.

Menarini Stemline is committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.