Feasibility Manager - Oncology (On-Site/Hybrid)

BioCT Innovation Commons; Connecticut; Hybrid; USD 115,000 - 181,000; Full time

Job summary

An established industry player is seeking a skilled Feasibility Manager to join their team in Ridgefield, CT. This role is pivotal in conducting comprehensive feasibility assessments for clinical trials, particularly within the Oncology sector. You will collaborate closely with internal stakeholders to ensure the success of trials by identifying capable investigators and sites. The position emphasizes data-driven decision-making and the maintenance of strong relationships with both internal and external partners. This innovative firm values its employees and offers a competitive compensation package, fostering a healthy work-life balance and opportunities for professional growth.

Benefits

Competitive Compensation

Performance-Based Bonus

Health Benefits

Work-Life Balance Programs

Qualifications

• 4+ years in regulated pharmaceutical or healthcare industry required.
• Experience in clinical trial feasibility with oncology focus preferred.

Responsibilities

• Lead US country feasibility analysis and manage site feasibility processes.
• Ensure compliance with regulations and maintain high ethical standards.

Skills

Project Management

Data Analysis

Stakeholder Management

Clinical Trial Feasibility

Oncology Knowledge

Education

Bachelor's Degree

Advanced Science/Clinical Degree

Tools

Clinical Trial Management Systems

Data Sources and Tools

Job description

The Feasibility Manager role is an On-site/Hybrid role, meaning it will be required to work from the Ridgefield, CT site 2-3 days per week.

This role is responsible for the development and deployment of comprehensive country and site feasibility assessments across Boehringer trials and programs and will be working specifically within Oncology. This role ensures recommendations are tactically feasible and considerate of the indications/assets from a holistic industry perspective. In close alignment with internal stakeholders, this role identifies highly capable investigators/sites to meet study requirements and business needs.

The Feasibility Manager applies expertise as a systems and database subject matter expert to improve integrity & quality of feasibility outputs. The incumbent utilizes data and available resources to ensure site selection goals can be met and patient recruitment goals are obtainable and strategic in accordance with upcoming BI trial landscape. This role will be an active representative of Site Planning and Optimization including on local & corporate process improvement projects & initiatives.

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, diversity and inclusion, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

Duties & Responsibilities

• Performs all company business in accordance with regulations (e.g., EEO, FDA, ICH, DEA, OSHA, PDMA, EPA, PhRMA, etc.) and Company policy and procedures.
• Immediately reports all noted/observed violations.
• Demonstrates high ethical and professional standards with all business contacts to maintain Boehringer's excellent reputation within the industry.
• Represents Site Planning & Optimization on projects and work streams, for process improvements or input which support company goals or objectives.

Manages US Country Feasibility Process:

• Leads data-driven, US country feasibility analysis (study, project, TA level) with input from cross-functional stakeholders and SMEs.
• Performs analyses and provides clear outputs with applicable recommendations.
• Responsible for holding related meetings & maintaining documentation.
• Develops and conducts trial and project feasibilities.
• Develops clear, comprehensive Country Feasibility assessment outputs.
• Presents outputs with applicable recommendations to key stakeholders & management to align on global feasibility responses and US patient/site allocations.
• Recommends and develops country feasibility solutions to aid in future Boehringer trials needs/assessments.

Responsible to lead the site feasibility process:

• Constructs site list for site feasibility outreach utilizing tools available and incorporating input from stakeholders.
• Executes site feasibility with sites, networks, strategic alliances.
• Identifies opportunities to expand the pre-qualified potential investigator/network pool in anticipation of future indications by TA.
• Identifies, evaluates, and recommends a sufficient supply of pre-qualified investigators for assigned trials with a focus on data driven site recommendations.
• In close alignment with the medicine team, guides the development and manages the collection of trial specific questionnaires/screens and conduct of site scoring.
• Identifies and recommend sites/networks as opportunities for alliances.
• Supports cross trial/indication/TA site feasibility needs and able to execute accordingly.

In accordance with SP&O processes, maintain and update required systems, databases & shared locations to ensure visibility to feasibility outputs throughout Boehringer Ingelheim:

• Deliverables include, but are not limited to, routine updates, quality of recommendations, process cycle timelines, etc.
• Ensures documentation is maintained in accordance with Corporate/Local procedures.

Drives a data informed culture:

• Functions as an early adopter/advanced user of data sources and tools which support feasibility.
• Represents US CD&O on the review & impact of data sources and tools.

Maintains & strengthens internal & external stakeholder relationships:

• Partners with US & Global functions to ensure alignment of and operational planning and execution of clinical trials.
• Provides regional contributions to local asset teams.
• Communicates team objectives and capabilities & enhances reputation of SP&O to a broader internal audience (I.e., CDMA and Commercial organizations).
• Partners with internal stakeholders to collaborate on and manage operational site/service provider relationships.
• Represents Boehringer Ingelheim to enhance external reputation.

Requirements

• Bachelor's Degree required; Advanced science/clinical degree (PharmD, M.D., DNP, DO, Ph.D., RN, Master’s) preferred.
• Experience in the regulated pharmaceutical or healthcare industry required; a minimum of at least four (4) years’ experience is preferred.
• Two-plus (2+) years Country/site clinical trial feasibility experience with a strong preference of Oncology experience.
• Thorough understanding of all phases of drug development (I-IV).
• Understanding of federal regulations pertaining to IND and NDA regulations.
• Experience working with cross-functional, matrix structured teams/organizations.
• Previous project management experience required OR demonstrated ability to gain respective skills, which include: emotional intelligence, ability to handle stress and make good decisions, strong planning and organization, ability to multi-task, and manage and support clinical teams & timelines.

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 Data

This position offers a base salary typically between $115,000 and $181,000. 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.