Clinical Trial Specialist
MorphoSys is focused on creating significant value for all of its stakeholders through a strategy that balances short- and long-term growth potential along with a focus on our customers. We are dedicated to bringing breakthrough medicines in oncology to market to help address unmet needs for patients with serious diseases. By applying our proprietary technologies, MorphoSys has become a world leader in the field of therapeutic antibodies. The company has established successful and lasting partnerships with industry-leading companies from the pharmaceutical and biotechnology sectors. For example, we recently entered into a global collaboration and license agreement with Incyte Corporation to further develop and commercialize MorphoSys' lead investigational asset.
The product pipeline, one of the broadest in the biotech industry, includes over 100 distinct investigational drugs, and more than 25 therapeutic antibodies in clinical trials. This foundation combining high science and innovative technology elevates the standards for how antibodies will be made in the future enabling their use as research, diagnostic, and therapeutic tools.
Through specific in-licensing and co-development activities of our own, and in conjunction with our partners, the company is adding higher value programs to the pipeline at a significant rate. Our comprehensive partnering strategy is an important feature of our business model, and a vital source of MorphoSys' financial strength.
To advance the development of Tafasitamab and in preparation for its planned commercialization MorphoSys founded MorphoSys US Inc., a wholly owned subsidiary of MorphoSys AG, and raised independent funding by successfully closing an IPO on the Nasdaq U.S. stock exchange in April 2018. Our focused, controlled growth and commercialization journey has been substantial starting in 2018 with our US IPO and culminating in our Incyte Corporation partnership in 2020. These three years have been important for MorphoSys as we continue to strive to deliver innovative medicines to patients who need them. The company is realizing our goal of becoming a fully integrated global biopharmaceutical company.
Tafasitamab is an investigational, Fc-engineered therapeutic antibody targeting CD19 that is in development for the treatment of B cell malignancies. The focus of the development program is on relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), a particularly aggressive form of lymphoma. Tafasitamab received a breakthrough therapy designation (BTD) from the FDA in 2017 based on preliminary data from the phase 2 L-MIND study, which is evaluating the safety and efficacy of Tafasitamab in combination with lenalidomide. MorphoSys published the final L-MIND data in May 2019, and filed the BLA for Tafasitamab with the FDA in December 2019 which got accepted on March 2nd, 2020 with a priority review status.
Job Summary & General Responsibilities
The Clinical Trial Specialist is responsible for supporting all aspects of operational activities of phase I-IV clinical trial(s) from planning through close-out as assigned under the leadership of the Clinical Trial Leader (CTL).
Provides support to the CTL in:
Organizing Clinical Trial Team (CTT) meetings and prepare meeting minutes
Tracking and following up on outstanding actions from the CTT meetings
Ensuring all operational trial deliverables as assigned are met according to timelines, budget, operational procedures and quality standards
Preparing outsourcing specifications and in the follow up with day to day operation with vendors
Managing in-house Trial Master File (TMF) and ensuring implementation of TMF management plan and QC plan
Managing interactions with the CTT and Vendors
Coordinating of activities to set-up trial-related systems and documents leading to site initiation
Planning investigator meetings or equivalent investigator training and monitor trainings
Collecting and tracking trial status such as enrollment, timelines and data entry/queries for updating the relevant internal/external boards
Ensuring accuracy of trial information in all trial databases, TMF, and tracking systems
Initiating trial close out activities and ensuring completion of final drug accountability
Ensures inspection/audit readiness including TMF documentation and participates in internal audits and inspections as required
Contributes to process improvement or acts as Subject Matter Experts for training or SOPs
Coaches new CTSs during their onboarding as assigned
Job Qualifications, Experience & Skills
Bachelor's degree or equivalent qualification in life science/healthcare
Min. 3 years clinical trial support experience required
Previous involvement with clinical study development, implementation or reporting activities preferred
Good communication, organization and tracking skills
Good knowledge of Good Clinical Practice
Familiar with clinical trial and drug development process
Ability to work in a matrix organization and demonstrates collaboration skills
Ability to work under pressure
Effectively prioritizes workload
Fluent English (oral and written)