Rita Kirk, Ph.D. Email and Phone Number

• Leadership of global R&D project teams for new drugs and new indications, formulation and combinations.• Steering of all nonclinical development activities as well as enabling drug development activities and ensuring drug supply for clinical studies investigating safety and efficacy of drugs in humans.• Creation and maintenance of project plans for drug development projects, comprising all relevant nonclinical, regulatory and clinical work packages and milestones.• Representation of all R&D aspects in global strategy for drug development.• Regular, transparent and pro-active presentation of project status, project progress and critical issues at steering committees clearly assigning status, risks, challenges and project opportunities as well as preparation of committee decisions.• Responsible for operational aspects according to CMC development strategy.• Responsible for the Project Management of In-Depth-Evaluation (IDE) of global license opportunities.

• Direct and manage drug development programs, and implement most aspects of company strategy and operations• Project planning and management of five investigator-initiated trials and a multi-center contract research organization (CRO)-managed trial in multiple countries, including protocols, budgets, reports, regulatory requirements, and hiring and oversight of CROs• Oversee applications, reports, and interactions with US and EU regulatory authorities, including management of expert consultants in successful preparation of an IND application and milestone meetings with the FDA• Package and present data to successfully garner interest from potential partners and investors; effectively lead due diligence process with multiple pharma and investors simultaneously• Lead and facilitate non-clinical programs and toxicology projects involving outside CROs, including selecting appropriate vendors, obtaining quotes and contracts, overseeing the performed work, and evaluation of findings• Manage the CMC program of peptide bulk API and finished dosage form manufacturing, including selection of manufacturers, contracts, oversight, and clinical and commercial planning• Team leader for managing, monitoring, and reporting for all government grants and contracts

• Project planning and management of clinical trials, including protocols, budgets, reports, regulatory requirements, and hiring of contract research organizations• Lead and facilitate non-clinical programs and toxicology projects involving outside contract research organizations, including selecting appropriate vendors, obtaining quotes and contracts, overseeing the performed work, and dissemination of findings• Management of peptide bulk API and finished dosage form manufacturing, including selection of manufacturers, contracts, and oversight• Team leader for managing, monitoring, and reporting for all government grants and contracts• Prepare study protocols and reports, grant applications, SOPs, and data presentations; assist in preparation of IND applications

Successful development of in vivo and electrophysiology experimental protocols to evaluate the efficacy of rycals in stabilization of the ryanodine receptor complexProgram director for evaluation of rycals in improvement of cardiac and skeletal muscle functionDirect and perform all work involved in a DARPA project grant, including related paperwork, and preparation and presentation of findingsSetup and maintenance of three in vivo research laboratories, including complete outfitting of space, writing IACUC protocols, management of animal colonies, and administrative supportOversee toxicology projects involving outside contract research organizations, including selecting appropriate vendors, obtaining quotes and contracts, overseeing the performed work, and dissemination of findingsAssist in preparation of patents, grant applications, study reports, and presentations of findingsParticipate in interviewing, hiring, training and supervision of staff

Development of in vivo experimental protocols to evaluate the efficacy of rycals in stabilization of the ryanodine receptor complexSetup and maintenance of an in vivo research laboratory, including complete outfitting of space, writing IACUC protocols, and administrative supportAssist in preparation of patent applications, grants, and presentations of findings

Developed in vivo and in vitro experimental protocols to evaluate the effects of chemokines on signaling in the cardiovascular system, contribution to atherosclerosis, and regulation of vasomotor responsesStudied transgenic mouse colonies to assess the effects of tissue specific knockout of CXCR4 on murine cardiovascular development and the role of CXCR4 in specific cell types of the vasculature

Development of in vitro experimental protocols to evaluate the signaling mechanisms involved in regulation and function of the integrin 3 via phosphorylation, and the effect of its phosphorylation state on cell adhesion, platelet activity, and thrombus formationPreparation of manuscriptsPreparation and acceptance of predoctoral fellowship from the American Heart AssociationPresentation of findings at national and international scientific meetings and in departmental forumsPresentation of novel scientific articles in departmental journal clubs

Coordinated and implemented research projects that involved phosphorylation of adhesion molecules and regulation of platelet functionLaboratory maintenance

2002 Instructor for Cell Biology, Graduate School of Basic Medical SciencesOrganized and delivered a 90 min lecture on cell adhesion moleculesReviewed information with students outside of classGenerated and graded exam questions; Discussed objectives of the day's lab with short lectureAssisted students in identifying and locating histological structures Reviewed previous lectures with students