About the Role:
Responsible for the development of clinical research strategies and independent direction of Phase 1-3 clinical studies while working with a cross-functional project teams (clinical project managers, preclinical/clinical pharmacology, biometrics, regulatory, drug safety). May work closely with Research and Preclinical Development to develop biomarkers necessary for the most effective evaluation of novel molecules in early clinical development. Responsible for medical oversight of Drug Safety activities in conjunction with operational activities of the Drug Safety Director. Partners with Business Development in the assessment of external innovation.

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Your Contributions (include, but are not limited to):

• Develops and implements study protocols as in conjunction with a multidisciplinary Development Team

• Assist in the identification and selection of clinical investigators for clinical trials and maintain appropriate communication and professional relationships as Sponsor medical monitor/representative

• Conduct medical assessment and disposition of adverse events (in conjunction with Drug Safety physician) and evaluate safety of clinical compounds prior to and during ongoing clinical studies;

• Oversee the clinical trials program in conjunction with Clinical Operations in accordance with NBI SOPs, Good Clinical Practice, and applicable regulations

• Analyze, interpret, and present results of clinical studies to internal and external audiences as directed by Sr. Management;

• Identify resource requirements, assist in budget planning and personnel forecasting for clinical research programs;

• Assists in the recruitment, training and development of the clinical teams.

• Identify and select clinical consultants

• Provide or assist in the scientific writing and review of clinical study reports and related regulatory documents;

• Provides periodic status updates and effectively communicates with Senior Management Team

• Leads the development of clinical biomarker strategies for early clinical development

• Assist in the recruitment, training and development of the clinical teams;

• Identify and select clinical consultants;

• Work with Medical Affairs and external opinion leaders to secure new collaborators and present trial results;

• Identify resource requirements, assist in budget planning and personnel forecasting for clinical research programs;

• Interface with Research, Product Development and Business Development to assess new product opportunities, develop clinical research strategy and product development plans;

• Other duties as assigned

Requirements:

• MD or DO degree with accredited residency training and board certification in relevant clinical specialty for the therapeutic area required and 2+ years of experience in clinical research and development (Phase 1-4) in either a pharmaceutical/biotechnology company or a clinical research/academic environment or related experience required

• Recognized as an internal thought leader with extensive technical and business expertise within a strategic organization

• Applies in-depth knowledge of own function, business / commercial / scientific expertise to solve critical issues successfully and innovatively

• Evaluates key business / scientific challenges and completes complex, ambiguous initiatives having cross-functional impact

• Strong interpersonal and communication skills as well as strong organizational and team leadership skills are required

• Able to work independently and prioritize multiple tasks and goals to ensure the timely, on-target and within-budget accomplishment

• Knowledgeable in Good Clinical Practice, regulatory procedures relevant to investigational drug development

• Strong knowledge in translational medicine and biomarker evaluation, clinical study execution, regulatory requirements and documents, study design, biostatistics, data analysis, report writing, and scientific presentation of data

• Able to effectively operate in a multi-level matrix corporate environment, requiring interaction with, and/or direction of clinical research project teams, including physicians, scientists, monitors, administrative, regulatory, commercial, and consultant personnel

• Demonstrated success managing interactions with external CROs, consultants and other contract organizations, especially from the context of a small group

• Proven track record of success across all phases of drug development, proven success record in clinical trial design

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The annual base salary we reasonably expect to pay is $254,600.00-$347,000.00. 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 35% 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.