Position Summary:This position is responsible for creating the full clinical development plans (CDP), including designing and writing protocols and analyzing results of clinical trials conducted with King products. This key position is committed to following the implementation of trial designs through long-term analysis, reevaluation, and ensuring fulfillment of regulatory requirements and KPI’s business needs. This position also provides strategic input about key drug development decisions and business opportunities.Education:MD RequiredTherapeutic Area - PainSpecific Pain area - OpenExperience:• A minimum of 12-years of direct industry driven, clinical practice experience as well as international clinical research experience, preferably with either a pharmaceutical company or CRO. •Direct experience in developing and implementing successful clinical development protocols and programs.•Direct experience with use of EDC in clinical programs.•Direct experience in working with the FDA and international regulatory bodies would be a significant benefit.Travel Requirements:•Minimal to moderate Certifications/Licensures:•Professional licensure in respective field of study is a significant benefit (e.g. licensed Pharmacist, licensed Physician, etc.) 

Essential Skills
Major Functional Areas and Tasks:Strategic: o Gives major input about strategic decisions and direction of KPI drug development programs, including selection of primary clinical indications and drug life-cycle management. o Advises senior management on commercial opportunities, scientific advances, competitive products and assessment of business opportunities. o Contributes to marketing and sales strategies through participation in the TAST meetings.o Provides scientific input and training for KPI and external PR and investor information. o Participates in the development of publication and disclosure strategy with the TASTs, Regulatory Affairs, Legal and Corporate Communications, via presentations, abstracts, and manuscripts. Decision-Making: o Defines progress milestones in projects and provides scientific direction on continuing, halting or modifying studies and projects. o Sets priorities, defines manpower and budgetary needs for projects. Scientific: o Determines scientifically sound and cost-efficient methods of evaluating drug efficacy and safety. o Basic knowledge of therapeutic and disease processes (e.g., etiology and pathology).o Ensures compliance of studies with applicable laws and regulations (ICH, GLP, GCP) and company SOPs. o Consults with medical professionals to define study endpoints and clinical site procedures. o Creates Clinical Development Plans; analyzes, interprets, presents and defends results of clinical studies. o Recommends new patent opportunities and collaborates with legal counsel to submit and maintain patents and to review patent opportunities. o Represents KPI to regulatory agencies and at national and international scientific meetings. o Serves as the internal expert on potential competition via scientific, pharmaceutical, medical and business literatures / publications.o Reviews proposals for due diligence and other partnership opportunities.Leadership: o Provides overall project leadership on KPI Clinical Development Plans and product development through interactions with senior management in all functional areas (Project Management, Statistics, Regulatory Affairs, Data Sciences, Pharmaceutical Development and Technical Operations). o Lead decision maker in selection and management of investigators, clinical research organizations (CROs) and other providers of clinical operations support services (e.g., central clinical labs, ECG core labs, imaging or angiography labs). o Ability to identify problems and take corrective action quickly and decisively.o Recruits and maintains relationships with clinical and scientific advisors, consultants, corporate partners, and investigators. o Serves as the Scientific Leader of the Project Teams. o Provides input to Investigator selection.o Provides significant input to CRO selection.Writing/editing: o Writes, edits and reviews study protocols, clinical study reports, and FDA submissions, including sections of INDs and IND annual reports, NDAs, documents to support meetings with regulatory authorities, and Investigational Drug Brochures. o Collaborates with clinical investigators, data scientists and statisticians to ensure accurate reporting of clinical study results. o Writes abstracts, manuscripts, prepares posters and slide presentations for national and international scientific meetings. 

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