Clinical Development Scientist (Senior Director)

The Clinical Development Scientist (Senior Director) is responsible for scientific oversight data integrity and quality of clinical trials in Internal Medicine with direct responsibility for clinical deliverables for one or more studies leading and contributing to process improvement initiatives. They may also manage supervise and mentor others.

JOB RESPONSIBILITIES

• Independently leads clinical execution of one or more studies; accountable for program level clinical deliverables

• May provide input to the protocol design document; leads development of the protocol including protocol amendments Protocol Administrative Change Letters and Dear Investigator Letters

• Represents the study team in internal protocol review governance submissions and interactions; partners with/supports the Global Development Lead in study and disease area strategy; may participate in protocol-related KOL and Health Authority interactions

• Ensures development of Study Informed Consent Documents and responses to external stakeholder (e.g. Health Authority and Independent Ethics Committee) requests

• Provides clinical guidance to the development of the Statistical Analysis Plan and Tables Listings and Figures

• Provides clinical guidance to the development of the clinical data collection strategy instruments and data review plan ensuring alignment with the protocol and SAP optimized data collection principles and clinical data review best practice; sets the clinical data review strategy and leads the team in the review of emerging clinical data and trends; reviews and queries data; presents data to internal and external stakeholders; partners with site-facing colleagues in support of data issue resolution; ensures all clinical queries are appropriately addressed in support of database lock

• Provides clinical guidance to the development of the Safety Review Plan and Safety Narrative Plan; reviews safety data and ensures clinical documents are updated in response to emerging safety profile; tracks and reconciles Serious Adverse Events; leads clinical safety data discussion during Safety Review Team meetings in collaboration with Medically Qualified Individual(s); reviews safety narratives

• Provides clinical guidance to the development of the Risk Management Plan; ensures clinical activities are consistent with the approved Plan and partners with key stakeholders to develop and implement risk mitigations

• Establishes and manages External Data Monitoring Committees and Adjudication Committees including chartering contracting provision and presentation of data and documentation and dissemination of Committee recommendations

• Develops site selection criteria provides clinical input to selection of sites and ensures protocol training is delivered to site-facing colleagues

• Participates in investigator meeting planning and develops and delivers protocol training; develops and delivers ongoing protocol training in response to e.g. protocol amendments emerging data issues and quality events

• Serves as the primary clinical point of contact with investigators and study team for questions relating to clinical aspects of the protocol; manages clinical response development delivery documentation and curation (e.g. in FAQ)

• Ensures protocol deviation sub-categories are established; ensures protocol deviations identified during clinical data review are reported; ensures all reported protocol deviations are appropriately managed and reconciled; leads protocol deviation trends review

• Ensures TMF compliance for clinical documents

• Provides clinical input and review of the Clinical Study Report

• Ensures disclosure of safety and efficacy data and trial conclusions; may contribute to publications

• Provides clinical support to audits and inspections including responding to and addressing audit and inspection findings

• May contribute to clinical sections of regulatory filings (e.g. Briefing Documents Pediatric Investigational Plan Investigator Brochure IND/NDA Annual Reports Periodic Safety Update Reports responses to Health Authority requests)

• Leads the adoption and implementation of continuous improvement / process enhancement activities and innovative approaches to maximize effectiveness of clinical trial execution at the program and portfolio levels; contributes to enterprise-level initiatives

• May have managerial responsibility for other clinical colleagues or contingent workers; may supervise mentor or develop others

BASIC QUALIFICATIONS

• Science degree (PhD PharmD or equivalent) with at least 7 years or MA/MS with at least 10 years or BA/BS with at least 12 years of Clinical Research experience in a similar role in the biopharmaceutical industry

PREFERRED QUALIFICATIONS

• Cardiometabolic disease experience e.g. obesity diabetes endocrinology etc.

• Clinical research experience in the biopharmaceutical industry in study design start-up conduct and close-out including regulatory submissions and inspections

• Scientific productivity via publications posters abstracts and/or presentations

• Extensive knowledge of clinical development global and regional regulation and ICH/GCP

• Clinical administrative and project management capabilities; effective verbal and written communication skills

• Experience launching managing and training clinical development teams

• Track record of achievement in pharmaceutical development; able to coordinate and execute clinical development during design start-up conduct close-out and reporting

• Understands the complexities and recent developments in the principal disease areas; competent discussing scientific and regulatory aspects of drug development

• Able to set priorities and manage cross-functional teams and complex projects to deliver milestones according to budgets and priorities; able to define and manage resource requirements

• Effective leader; able to mentor/coach delegate to and oversee others; able to develop others skills and move them toward autonomy

• Able to resolve conflicts equitably; fosters open dialogue; addresses conflicts; reads situations quickly; negotiates agreements; escalates issues when appropriate; takes responsibility for decisions

• Shares wins and success; defines success in terms of the whole team; develops strong team morale and spirit; creates a sense of belonging

• Takes personal responsibility for delivery of results

• Able to demonstrate perspective and poise in uncertainty and organizational change

NON-STANDARD WORK SCHEDULE TRAVEL OR ENVIRONMENT REQUIREMENTS

Global travel may be required

Work Location Assignment:This is a hybrid role requiring you to live within commuting distance and work on-site an average of 2.5 days per week.

Relocation assistance may be available based on business needs and/or eligibility.

Candidates must be authorized to be employed in the U.S. by any employer.

U.S. work visa sponsorship (such as TN O-1 H-1B etc.) is not available for this role now or in the future.