Development and strategic planningResearch administrationFinancial managementProject management

Responsible for safety, quality, delivery and financial objectives. Supported more than 300 customers with analytical development and testing services.

Responsible for Analytical Development Services group, including Stability (Analytical and Storage), Quality Control & Compendial Analysis, and Early Development.

Serve on dissertation committee for student in Dept. of Pathology and Laboratory Medicine.

·Manage global Medical and Scientific Affairs Department, including Medical Writing, Medical Monitoring and Drug Safety, and Clinical Development (15 employees in US, Germany and India)•Serve as Clinical Development Liaison for portfolio drug development partnerships with pharmaceutical/biotechnology companies in oncology, CNS, cardiovascular and infectious disease•Represent global drug development services business as part of Jubilant Life Sciences integrated programs. Interface with sponsors, prepare integrated drug development proposals•Successfully managing six opportunities currently with large pharma and biotechnology companies. Assisted with closing one large pharma deal in 2011.•Serve as senior scientific advisor for business development activities across the organization, including devising strategy for targeting potential sponsor companies•Prepare scientific/medical considerations for proposals across therapeutic areas•Create and deliver therapeutic training to Clinsys personnel•Develop, write and/or edit clinical development plans, protocol synopses, and full protocols•Develop, write and/or edit orphan drug applications, pre-IND briefing books and IND applications•Perform research and prepare scientific/market/competitive landscape reviews of drug development programs for business development and in the process of vetting assets for sister company•Created and maintain published literature database as a resource for the company•Research and prepare background materials (white papers) in specific CNS and oncology indications•Interface with biostatistics, data management, regulatory services, drug safety, and clinical operations departments•Communicate directly with clients and KOLs and participate in bid defenses, kick-off meetings

· Serve as chairperson of Process Review Committee · Serve as senior scientific advisor on clinical project teams in CNS and oncology · Provide scientific support for business development team at capabilities presentations and bid defenses · Train Clinsys personnel in therapeutic areas · Review and provide scientific input for proposals and other requests for information · Plan, write, and/or edit clinical development plans, protocol synopses, and full protocols in area(s) of expertise · Plan, write, and/or edit orphan drug applications, pre-IND briefing books and IND applications · Prepare scientific/market/competitive landscape reviews of drug development programs as part of the investment/partnership vetting process for sister company · Create and maintain database of published literature (organized by indication) for use by clinical project teams · Prepare scientific background materials ("white papers") in specific CNS and oncology indications · Organize Therapeutically-aligned Program Strategist (TPS) teams for CNS, Dermatology, Respiratory and Cardiovascular · Interface with biostatistics/data management personnel, medical and drug safety staff, regulatory services department and project managers as a member of project teams · Communicate with clients on project-related issues and questions · Participate in internal and client meetings (bid defense, kick-off meetings, rally meetings, investigator meetings) · Management of one clinical scientist and one intern in matrix organization · Publication of four manuscripts in peer-reviewed journals · Certification as Six Sigma Green Belt

Regulatory Experience and Responsibilities: · Served as senior scientific advisor on clinical project teams · Planned, drafted, and edited clinical trial protocols, pre-IND briefing documents, Investigator's Brochure, IND, literature summaries · Performed regulatory document reviews · Provided scientific support for business development team at capabilities presentations and bid defenses · Trained Clinsys personnel in therapeutic areas · Served on Standard Operating Procedures (SOP) Review Team · Managed one internal Clinsys employee and three external medical writing contractors · Prepared and filed an IND for Phase 2 ADHD study

Management Responsibilities and Experience: · Directed all internal and advised on external research programs in oncology and CNS-related indications (including Alzheimer's disease research). Provided day to day management of laboratory and a scientific team consisting of four scientists and a patent agent. · Provided guidance in the development and participated in authoring patent applications as an inventor. · Served as the scientific spokesman for the company at international meetings, at press briefings, and in meetings with the investment community. · Presented scientific rationale and clinical data for Alzheimer's therapeutic and oncology indications to bankers, venture capital firms, pharmaceutical companies and shareholders, as part of overall capitalization and partnering strategy. · Served on the Communication Review Team. · Interfaced with the Alzheimer's research community at scientific meetings and helped to recruit and establish a medical and scientific advisory board. · Provided scientific direction to the company for potential pipeline products. · Developed collateral materials and scientific presentations of experimental and clinical data for distribution at meetings and for private placement memoranda and filings to the Securities and Exchange Commission. · Established and directed scientific publication strategies. · Established relationships with academic and government clinical trial sites to provide clinical trial expertise for pipeline products.

Management Responsibilities and Experience: · Responsible for establishment of molecular biology/protein biochemistry laboratory, including laboratory design, budgeting, scientific staffing, securing all necessary certifications for management of radioactivity, a vivarium, and laboratory safety. · Responsible for management of laboratory, including budget, staffing and scientific direction. · Authored patent applications as an inventor and managed patent applications through the patent review process.

Regulatory Experience and Management Responsibilities: · Provided scientific support for patent development. · Served as scientific liaison with collaborating academic laboratories. · Primarily responsible for interfacing with the Food and Drug Administration and the regulatory management of an open IND for two Phase II Alzheimer's disease clinical trials. · Responsible for reporting of adverse events, filing MedWatch forms, and maintenance of regulatory records. · Managed and contributed to the writing, assembly and filing of an IND for a Phase I safety and tolerability trial.

Management Responsibilities and Experience:•Established laboratory and staffed with one technician. Became faculty advisor for one graduate student.•Secured federal and university funding to support laboratory.•Served on departmental graduate student admissions committee.•Served as laboratory instructor for Gross Anatomy I, UNC Medical School, Fall 2002.•Published five manuscripts in peer-reviewed journals.

Management Responsibilities and Experience:•Directed research team of two technicians. Collaborated with several other laboratories on various projects and successful grant applications.•Served as laboratory instructor for Gross Anatomy I, UNC Medical School, Fall 2001•Became member of UNC Lineberger Comprehensive Cancer Center.•Published twelve manuscripts in peer-reviewed journals.

Molecular and cell biology research focused on androgen receptor function in prostate cancer