Senior Director, Clinical Science

SENIOR DIRECTOR, CLINICAL SCIENCE

Position Summary:

Global Blood Therapeutics is looking for an experienced leader and innovative drug developer with passion and creativity and who places the patient at the center of everything they do.

The individual will be a self-starter with excellent, communication (within and outside of the organization) and multi-tasking skills. They should have a strong experience with clinical study conduct, data analysis and health authority document preparation and interactions.

Essential Duties and Responsibilities:

• Clinical point of contact for all study related matters including clinical study operational conduct, data gathering, analysis and interpretation, safety assessments, regulatory documentation and publications
• Execution of study related activities in a GCP-compliant manner
• Clinical lead in communications to senior management and governance committees on study progress and strategic updates
• Perform responsibilities independently and exhibit proficiency as the Medical Monitor for clinical trials
• Support Health Authority document writing, review and interactions, including protocols, CSRs, Information Requests, CTD modules for regulatory filings, Investigator Brochures, pediatric investigational plans, and aggregate reports for pharmacovigilance
• Provide medical support for allied non-Development functions within the organization, including Business Development, Commercial, Corporate Communications, Medical Affairs, Research, and Technical Operations

Cross-Functional Team and People Management

• Participate in Product Development Teams (PDTs) and lead product-specific Clinical Sub Teams (CSTs)
• Represent Clinical Science in program sub-teams
• Provide clinical leadership to support the training and monitoring of study sites
• Review and provide guidance on appropriate personnel assignments and budgets
• Where applicable, hiring, retaining and managing direct reports and clinical consultants

Clinical Development Planning

• Take a leadership role in proposal development to identify effective clinical and regulatory implementation strategies
• Stay abreast of internal and external clinical and SCD landscape developments and update Clinical Science and other development functional areas
• Participate in Health authority document preparation and interactions
• Provide clinical input into the relevant therapeutic/disease area scientific strategy
• Provide clinical input for transitioning new drugs/indications into clinical development

Clinical Development Plan Implementation

• Provide clinical oversight of relevant studies and progress, including participation in Study Execution Team meetings, reviews of medical/safety data, CSR writing
• Provide clinical leadership for clinical studies, including site feasibility/startup, site interactions, fielding medical questions, clinical monitoring, and conducting Investigator Meetings
• Represents GBT through collaborations with internal and external partners such as investigators, clinicians, scientists and key opinion leaders
• Collaborate with Biometrics to ensure appropriate medical/scientific data collection and interpretation for study reporting and health authority interactions
• Lead, develop and provide clinical science input into annual strategic lifecycle plans

Qualifications:

• Bachelor of Science or equivalent degree required; MS, MBA or equivalent may be desirable; specialty training in hematology or industry experience working on hematology products strongly desired
• 12-17+ years of industry experience, predominantly in a clinical development role, ideally with significant experience in authoring study protocols, collaborating with thought leaders, data safety monitoring boards, and clinical investigators, interacting with regulatory agencies, starting up clinical trials, medical monitoring, evaluating potential safety signals, and authoring CSRs
• 5+ years of experience managing people desired for leadership positions
• Experience in writing and submission of Health Authority documents, including INDs, NDA/BLAs, Information Requests, and pediatric investigational plans
• For Senior Directors, at least 5 years of line management experience desirable
• Ability to work independently and in a fast paced, hands-on, growth-oriented work environment

Fit with GBT culture:

• Ability to build strong relationships with co-workers of various backgrounds and expertise
• Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor
• Values-based leadership consistent with GBT's Core Values
• Excitement about the vision and mission of GBT
• Flexibility
• Integrity

NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

Global Blood Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or any other characteristic protected by law.

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