About the Role: Supports clinical development in early and late phases through registration. Responsibilities include informing study design, overseeing execution, maintaining databases, data analyses, and summary of results. Contributes to multidisciplinary teams through complex decision-making, integrating input from medical, scientific, regulatory and commercial perspectives with emphasis on clinical trial methodology, management and development of outcome measures. May be a resource to program teams for guidance of all matters related to analysis and communication of clinical data. May lead program discussions and data presentations internally and externally. Your Contributions (include, but are not limited to): • Provides clinical support and scientific opinion to study teams and functional areas such as regulatory, clinical operations and line management • Provides input to study design, protocol concepts/protocols preparation, statistical analysis plans, and reporting within assigned programs to yield high value clinical endpoint insight for future critical decisions • Contributes within clinical development program teams on selection of established and development of novel outcome measures in the context of clinical trials in early and late stages of clinical development • Leverages personal subject matter experience, and conducts research into relevant literature, to identify optimal development paths, clinical study designs,and outcomes for inclusion in clinical trials • Collaborates with external opinion leaders. internal clinicians, translational sciences and clinical operations to ensure appropriate study designs are achieved for successful implementation of • Works with study and program teams to achieve program goals and provides deliverables in approved timeframes • Monitors patient data and study-related information related to clinical study sites and clinical trial participation • Monitors site adherence to protocol activities and expectations and works with sites to ensure clear, concise and accurate data entry • Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency Requirements: • BA/BS or MA in Data Sciences, Psychology or related field and 2+ years of industry relevant experience • Provides timely and accurate monitoring of patient data and study-related information from source documents, research records, and site visits where applicable. • Applies best regulatory practices and drug development precedent to assigned programs • Supports the development of regulatory documents for filings and agency meetings • Reviews and interprets scientific knowledge of competitor landscape (molecule/indication) • Proactive identification of issues/problems and recommend solutions • Participate with team members to prepare abstracts, manuscripts, and presentations for external meetings as well as author clinical sections of regulatory documents (IB, IND sections) • Remains up to date with current information on pharmaceutical regulations, guidelines, and practices and therapeutic area knowledge and ensures consistent best practice across all activities • Maintains knowledge of ICH-GCP, external regulations and procedures – required for regulatory filing • Strategic skills thinking skills with the ability to synthesize data, formulate, develop and execute clinical strategies • Excellent computer skills • Excellent communications, problem-solving, analytical thinking skills • Excellent project management skills. May develop an understanding of other areas and related dependencies The hourly rate we reasonably expect to pay is $35.35-$47.34. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 15% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.