Neurocrine Biosciences · 2 days ago
Scientific Director, Clinical Development - Endocrinology
San Diego, CA
Full-time
Onsite
Director/Executive
$188K/yr - $256K/yr
7+ years expNeurocrine Biosciences is a leading neuroscience-focused biopharmaceutical company dedicated to developing life-changing treatments for patients with under-addressed neurological and neuroendocrine disorders. The Scientific Director, Clinical Development - Endocrinology will oversee the clinical and translational strategy for compounds in development, ensuring effective study design and execution throughout all phases of clinical development.
BiotechnologyHealth CarePharmaceutical
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
Qualification
Required
BS/BA degree in Biology, Chemistry, or related science field
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
Benefits
Annual bonus with a target of 35% of the earned base salary
Eligibility to participate in our equity based long term incentive program
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
Company
Neurocrine Biosciences
Neurocrine Biosciences engages in the discovery and development of drugs for the treatment of neurological and endocrine-related diseases.
1001-5000 employees
H1B Sponsorship
Neurocrine Biosciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (16)
2024 (9)
2023 (8)
2022 (2)
2021 (5)
2020 (6)
Funding
Current Stage
Public CompanyTotal Funding
$260MKey Investors
Venrock
2015-02-19Post Ipo Equity· $250M
2009-12-17Post Ipo Equity· $10M
1996-05-31IPO
Leadership Team
Matt Abernethy
Chief Financial Officer
D
Dimitri Grigoriadis
VP, Research
Recent News
2026-01-06
Company data provided by crunchbase