The Clinical Scientist will provide scientific, pharmacologic and/or medical input into Curis publications, trial designs and protocols across all stages of clinical development and support regulatory submissions worldwide. This person will work with cross-functional teams and global collaborations to integrate broad medical and scientific input into assigned development programs. This individual will work with clinical research, translational, program management, regulatory and operational staff (among others) to develop and implement protocols, publications, presentations and submissions that advance clinical development plans for assigned programs and molecules.
This role will work with cross-functional and global collaborations to integrate broad medical and scientific input into Curis’ development programs and clinical development plans for assigned programs and molecules. Depending on corporate/programmatic needs and individual aptitudes, the role may primarily focus on Safety, Clinical or Scientific Research aspects of assigned programs.
Responsibilities in collaboration with the project physician will include, but are not limited to:
• Project work and responsibilities as appropriate, including:
a. Prepare and/or assist with preparation of key documents e.g., Investigator Brochures, regulatory submission documents, internal and external presentations;
b. Prepare synopses and protocols (writing, reviewing, amending and cross-functional facilitation as appropriate) and Informed Consent Forms;
c. Participate in clinical development plans for assigned compounds;
d. Review safety, primary efficacy variables, and laboratory data
• Review scientific literature and prepare presentations, regulatory submission documents, etc.;
• Collaborate with and support interactions with clinical sites as needed;
• Support the planning of investigator meetings with Meeting Planning. Develop and deliver study specific training presentations as needed
• Review clinical data including: safety, primary efficacy variables, and laboratory data.
• Participate in reviewing and testing of specifications and edit checks for internal (i.e. electronic data capture (EDC) and external (e.g. Interactive Voice/Web Response Systems (IVRS/IWRS), laboratory vendors) systems. Monitor data during the course of the study. Identify potential clinical data issues and provide senior team members with feedback to remediate issues.
• Assist in the review TFLs and SAS outputs of cleaned data at test runs and database close.
• Contribute to the development of clinical study report.
• May contribute to the review for SOPs, training guidances, and templates as needed.
• At least 2-4 years clinical research experience in the pharmaceutical industry or CRO
• PhD/PharmD/RN/DO or the equivalent preferred.
• Oncology experience required;
• Working knowledge of clinical trial design and execution;
• Experience in protocol development and regulatory submissions;
• Adherence to the highest standards for trial conduct, patient safety and data integrity;
• Medical/technical writing and basis statistics expertise preferred;
• Working knowledge of GCP, ICH Guidelines and standard medical terminology;
• Facility with Microsoft Office applications (e.g., Excel, Powerpoint);
• Electronic data capture (EDC) system (PhaseForward, InForm) background
• Proficiency in literature searches and standard data mining, interpretation and presentation;
• Ability to assimilate technical and scientific information accurately and quickly;
• Able to work with cross-functional teams and meet deadlines in a fast-paced work environment;
• Outstanding written and verbal communication skills; and
• Meticulous and well-organized.
Curis is a publicly-traded biotechnology company (NASDAQ: CRIS) focused on the development and commercialization of innovative drug candidates for the treatment of human cancers.
Curis’s most advanced drug candidate is CUDC-907, an orally-available, small molecule inhibitor of histone deacetylase, or HDAC, and phosphatidylinositol-3-kinase, or PI3K enzymes. Curis is currently investigating CUDC-907 in a Phase 2 clinical trial in patients with relapsed or refractory diffuse large B-cell lymphoma, or DLBCL with alterations in the MYC oncogene. Curis is also conducting a Phase 1 study of CUDC-907 in patients with solid tumors, and has recently directed efforts in this study to enroll patients with MYC oncogene involvement, including patients with NUT midline carcinomas, or NMC.
In addition, Curis is party to an exclusive collaboration agreement focused on immuno-oncology and selected precision oncology targets with Aurigene Discovery Technologies Limited, or Aurigene, a specialized, discovery stage biotechnology company and wholly-owned subsidiary of Dr. Reddy’s Laboratories (NYSE: RDY). In October 2015, Curis exercised options to license the first two programs under this collaboration. The first licensed program is focused on the development of orally-available small molecule antagonists of PD-1 and VISTA in the immuno-oncology field, including the development candidate currently being investigated in Phase I clinical trials, designated CA-170. The second licensed program is focused on orally-available small molecule inhibitors of Interleukin-1 receptor-associated kinase 4 (IRAK4) in the precision oncology field. In addition, in October 2015 the Company selected a second preclinical program within the immuno-oncology field that is focused on evaluating small molecule antagonists with dual PD-1 and T-cell immunoglobulin and mucin domain containing protein-3 (TIM-3) targeting properties. Curis expects to file an IND and initiate Phase 1 clinical testing of the IRAK4 inhibitor in 2016.
Curis’ other collaborators, F. Hoffmann-La Roche Ltd, or Roche, and Genentech Inc., or Genentech, a member of the Roche Group, are commercializing Erivedge® (vismodegib), a first-in-class orally-administered small molecule Hedgehog signaling pathway inhibitor, in advanced basal cell carcinoma, or BCC. Roche and Genentech are also continuing Erivedge’s clinical development in less severe forms of BCC, and have recently initiated clinical studies of Erivedge in idiopathic pulmonary fibrosis, or IPF, and myelofibrosis.
Our corporate culture is focused on learning and growing in a challenging environment with a committed group of peers working together as a team.
For more information, visit Curis' website at www.curis.com.
Curis is an Equal Opportunity Employer.