Scientific Director, Clinical Development - Endocrinology

Neurocrine Biosciences

2d

About The Position

A responsible member of the clinical and program teams, dedicated to the development and execution of the clinical and translational strategy and program (scientific, clinical, and operational) of compounds in development, leveraging expertise in clinical trial methodology, statistical principles, and regulatory strategy. Directs study design, protocol development and execution of clinical research studies in all phases of clinical development through registration (NDA/MAA). Accountable for end-to-end execution of process for each assigned clinical project in a timely and cost-effective manner. Contributes to the interpretation and reporting of clinical study results. Leads multidisciplinary team through complex decisions, integrating input from medical, scientific, regulatory, and commercial perspectives with emphasis on clinical trial methodology, management and development of outcome measures and will also be a resource to program teams for guidance of all matters related to analysis and communication of clinical data. May also participate in the evaluation of business development including licensing opportunities.

Requirements

• BS/BA degree in Biology, Chemistry, or related science field and 15+ years of relevant experience OR Master’s in Biology, Chemistry, or related science field and 13+ years of related experience OR PhD or equivalent combination of education and work experience and 7+ years of related experience
• Has knowledge of best practices in the functional discipline and familiarity with the broader underlying concepts of related business disciplines
• Strategic skills thinking skills with the ability to formulate, develop and execute clinical strategies
• Works to improve tools and processes within functional area
• Develop reputation inside the company as it relates to area of expertise
• Ability to work as part of and lead multiple teams
• Exhibits leadership skill and ability, typically leads lower levels and/or indirect teams
• Excellent communications, problem-solving, analytical thinking skills
• Ability to see the broader picture and impact on multiple departments/divisions
• Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency
• Excellent project management skills
• Excellent computer literacy
• Assimilates data and research findings outside of Neurocrine for application to new scientific projects
• Maintains substantial knowledge of scientific principles and theories and possesses intellectual mastery of one or more scientific areas
• May develop an understanding of other areas and related dependencies
• Advanced knowledge and demonstrated ability working with / recommending a variety of laboratory equipment/tools
• Knowledge, experience, and skills typically developed by a strong track record of accomplishment in the field of translational research in Neuroscience
• Experience in developing medicines for Mood Disorders, Schizophrenia and other psychiatry diseases
• Experience in the design and conduct of Phase I/2/3 studies in Neuroscience

Responsibilities

• Representative of the clinical team, dedicated to the development and execution of the clinical strategy and program (scientific, clinical)
• Providing recommendations to and expertise to study teams and functional areas such as regulatory, clinical operations and line management
• Designs clinical development plans and study protocols within assigned programs to yield high value clinical insight for future critical decisions
• Leads effort within clinical development program teams to identify appropriate assessments and to develop novel outcome measures as needed for clinical trials in early and late stages of clinical development
• Manages the development of the target product profiles, clinical development plans, Investigator’s Brochures, clinical study concepts/protocols, clinical study reports, regulatory documents, and other critical clinical study documents, for each clinically assigned project or program in partnership with supporting departments
• Uses subject matter experience to influence clinical teams, conducts research into relevant literature or competitor activities, identify optimal study design including population selection and clinical endpoints
• Collaborates with external opinion leaders, internal clinicians, translational sciences and clinical operations to ensure appropriate study designs are achieved for successful implementation of data analyses and accomplishment of intended study outcomes
• Designs trials from a patient-focused perspective and collaborates with opinion leaders and patient advocacy groups to inform study design and procedures
• Drives critical decisions including preparation of critical success factors, go/no-go decisions, dose selection, etc.
• Works with research and pharmacology colleagues to develop translational plans for disease models and biomarkers
• Works with commercial colleagues to develop clinical strategies for optimal product positioning and reimbursement
• Works with health economics and outcomes research colleagues to align clinical plans and trial designs with real world data from registries, claims and medical records
• Manages and supports study and program teams to achieve program goals and provides deliverables in approved timeframes
• Provides timely and accurate monitoring of all study data (patient data, clinical site data, source documents, etc.)
• Leverages data analytics and data science approaches in a cross-functional manner to produce insights before (e.g. modeling), during (e.g. blinded analytics), and after (e.g. post-hoc analysis) a clinical study
• Monitors the investigator adherence to research protocols, regulatory requirements and good clinical practices and provides input into data validation plan
• Monitors study sites and audit facility selection; including site visits as needed
• Implements best regulatory practices and drug development precedent to assigned programs
• Provides recommendations of 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 recommends solutions
• Directs and manages 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
• Liaises with bioanalytical laboratories, pharmacokinetic scientists, biomarker representatives and data managers to ensure key PK, PD and clinical safety data are available when needed for critical Clinical Team decisions
• Liaises with statisticians and programmers to help develop and implement the statistical data analysis plans
• Evaluates and selects clinical study research centers and appropriate investigators
• Leads clinical support for Regulatory Affairs activities for a clinical program (e.g., health authority documents/responses, labeling, filing activities)
• Collaborates/assists with safety responsible physicians in medical monitoring and evaluation of adverse events, patient eligibility, and protocol deviations in clinical trials
• Provides guidance to the interpretation and reporting of clinical research results and presents results to internal and external audiences
• Prepares presentations, medical publications, etc emerging from the team and its affiliates
• Creates and manages the budget for all project related activities (internal and external partners) of each individually assigned project
• Subject eligibility review
• Mentors or develops clinical team members
• Other duties as assigned

Benefits

• retirement savings plan (with company match)
• paid vacation, holiday and personal days
• paid caregiver/parental and medical leave
• health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 1,001-5,000 employees