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 Manager is accountable for providing oversight to the site management activities of phase I-IV clinical trials outsourced to a vendor i.e. Contract Research Organization (CRO) from trial planning and site feasibility through study close-out, in compliance with MorophoSys processes, ICH GCP and regulatory requirements.
- Maintains a strong knowledge of the protocol to be able to answer operational questions from CRO Site Management Team (i.e. Clinical Trial Managers/Lead Clinical Research Associates (CTMs/Lead CRAs) and Clinical Research Associates (CRAs) and investigator sites
- Recognizes potential challenge within the protocol and operational aspects of the trial and escalates to Clinical Trial Leader (CTL) for development of appropriate actions if required
- Contributes to the development of trial execution plan and supports trial feasibility
- Trains CRO Site Management Team on the protocol and key trial elements together with CTL for performing site selection
- Recommends list of sites for trial participation to Clinical Trial Team (CTT)
- Develops and implements site management oversight plan
- Monitors the progress of site selection and site initiation visits
- Works with CRO Site Management Team and ensures that all essential documents are in place for approval of site initiation and release of Investigational Medicinal Products (IMP) to the sites
- Provides training as needed to the CRO Site Management Team and any other activities that support site readiness to recruit
- Ensures monitoring visits are performed by CRO CRA according to the monitoring plan
- Reviews site issues and relevant monitoring visit reports to identify quality/compliance issues that require escalation to CTL and/or require follow-up with the CRO Site Management Team for resolution with the sites
- Performs co-monitoring visits with the CRO CRA as required
- Performs periodic review of protocol deviations and issues to identify any trends for communicating and taking appropriate actions with CTL and/or Quality Assurance
- Provides governance on country and site-specific TMFs maintained by the CRO Site Management Team
- Communicates with CRO Site Management Team on a regular basis to assure proper adherence to protocol, timelines and other trial related topics
- Serves as main contact to CRO Site Management Team for any potentially significant quality/compliance issues and escalates to CTT as required
- Attends and participates in CTT meetings
- Reviews and communicates with CRO Site Management Team to ensure timely CRF data entry and resolution of data issues by the sites
- Ensures that all trial close-out activities are performed, in close cooperation with CRO Site Management Team and CTL
- Participates in internal audits and HA inspections as required
- Leads or actively contributes to process improvement or acts as Subject Matter Experts for training or SOPs
- Coaches new CTMs during their onboarding as assigned