at Loxo@Lilly in Springfield, Illinois, United States
Job Description
About Loxo@Lilly:
Loxo@Lilly aims to create medicines that make life better for all those affected by cancer around the world. Bringing together the focus and spirit of a biotech with the scale, resources, and heritage of Lilly, our team is focused on rapidly delivering impactful new medicines for people with cancer. Our approach centers on creating oncology medicines that unequivocally show early signs of clinical activity and will matter to patients. We intend to curate a balanced pipeline of medicines, either internally or externally discovered, with the potential to treat cancer with dramatic effect. Loxo@Lilly was created in December 2019, combining the Lilly Oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. Loxo@Lilly is a global organization with team members in Louisville, Colorado; Indianapolis, Indiana; New York City, New York; San Diego, California; South San Francisco, California; Stamford, Connecticut; and Madrid, Spain.
Position Summary:
This role is responsible for oversight of all Clinical Data Management (DM) related work for assigned Clinical Pharmacology studies conducted by or on behalf of Loxo Oncology at Lilly. This will include, but not limited to the following responsibilities: overseeing CRO’s, data collection strategy, data flow management, transfer management, maintaining a high degree of data quality and integrity and any other activities pursuant to study execution per policy and protocol.
This role will work closely with program leads from cross functional groups including, but limited too, Clinical Operations, Biostatistics, Medical Monitoring. This role is also responsible for DM vendor management, contract reviews and relationships to ensure vendor tasks and responsibilities are in compliance with standard operating procedures and regulatory agency guidelines. This role ensures all Data Management activities stay within full compliance of Loxo regulatory and legal policies.
Roles and Responsibilities of the Position:
+ Represent CDM from a strategic planning and execution capacity in development team meetings.
+ Oversees service providers to perform core data management functions including CRF design, edit check development, user acceptance testing, data cleaning, reviewing listings, and database locking procedures.
+ Evaluates and makes recommendations related to inter- and intra-departmental processes in order to identify and implement efficiencies and quality improvement measures Leads and manages DM tasks outsourced to external vendors and ensures that milestones, deliverables, quality and timelines are met within budget and in accordance with regulatory requirements.
+ Executes according to the DM outsourcing and related strategies and processes, developing positive partnerships with CROs and ensuring a high standard of deliverables is maintained.
+ Works closely with Data Management Clinpharm Leadership (DMCP) for streamlining DM related aspects.
+ Supports collaboration, communication, coordination and prioritization within the department working in conjunction with line Manager and DM CP Leadership.
+ Contribute to the evaluation of RFPs, subsequent bid defenses and the eventual selection of vendor partners.
+ Proactively identifies potential Study and delivery issues/risks and recommends/ implements solutions.
+ Serves as the DM focal point on assigned studies for all internal and external teams and preserves a fluent workflow with the cross-functional departments and stipulated procedures and processes.
+ Develop and ensure that deep knowledge of internal, external and regulatory requirements/expectations are understood, well communicated and applied to data deliverables.
+ Effectively apply knowledge of applicable internal, external, and regulatory requirements/expectations (MHRA, FDA, ICH, GCP, PhRMA, Privacy, etc) to data collection, validation and CDM documents.
+ Support CDM department-level improvement initiatives.
+ Monitors the progress of all data management activities on all studies to ensure project timelines are met.
+ Performs all other tasks and activities as assigned/requested.
+ Represents Data Management and facilitates project related integration with other groups, notably Clinical, Operations Stats Programming, Statistics, QA and Regulatory.
+ Collaborate with other Clinical Data Management leads upon need.
+ Authors, Reviews or Approves Data Management Plans for completeness and accuracy as required by relevant SOP.
+ Provides input into CDMS development and requirements, assuring protocol requirements are met. Oversees and performs risk-based UAT on CDMS components as needed.
+ Acquires knowledge related to drug development, clinical trials methodology, and applies the relevant information in recommending changes in data management to better satisfy business requirements.
Required Qualifications and Preferred Background:
+ Required:
+ Bachelor’s degree in life sciences, math, computer science or related field required.
+ Minimum of 5+ years’ clinical data management experience.
+ Minimum of 3 years’ Oncology/Hematology experience.
+ Demonstrated knowledge of drug development processes.
+ Demonstrated project management skills.
+ Demonstrated ability to effectively partner/influence cross functionally to deliver results.
+ Thorough and broad knowledge of data management processes, including EDC and interactive voice response system (IVRS)experience.
+ Knowledge of regulatory guidelines such as GCP, 21 CFR Part 11 etc.
+ Knowledge of study data tabulation model (SDTM, ADaM, CDISC).
+ Must have excellent verbal, written and communication skills.
+ Ability to work independently as well as in a team environment.
+ Excellent time management skills and a proven ability to work on multiple projects at any given time in a fast-paced environment.
+ Demonstrated ability to stay abreast of trends and new information in the profession.
Ideal candidate will also have:
+ Managing or Oversight of healthy subject/clinical pharmacology studies.
+ Sponsor experience is a plus.
+ Line Management experience is a plus.
+ Advanced degree strongly preferred.
Available Locations for this Role:
+ Remote- US Based
+ Stamford, CT
+ South San Francisco, CA
Loxo@Lilly currently anticipates that the base salary for the Associate Director level could range between $109,500 to $160,600. and will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. This position will also be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Loxo provides a comprehensive benefit program to eligible employees, including vacation, medical, dental and vision benefits; participation in a 401(k) plan; life and accidental death and disability coverage; parental leave benefits and employee discounts for certain items. The compensation described above is subject to change and could be higher or lower than the range described.
Physical Demands/ Travel:
The physical demands of this job are consistent with light office duties.
This position will travel occasionally; up to 10% with some variation based upon the demands of the business imperatives.
The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Work Environment:
This position’s work environment is in an office setting.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
_*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of
