Director, Clinical Management

About the role

The Director is responsible for the operational strategy and management of clinical development programs, with a strong preference for experience supporting Central Nervous System (CNS) therapeutic areas. The Director will provide leadership across cross-functional teams to ensure successful planning, execution, and delivery of global clinical programs.

Responsibilities

• Provides scientific clinical research and operational expertise in the development of overall strategy and objectives of the Global Clinical Development Plan (GCDP), including performing/overseeing and providing background research.
• May represent Clinical Management in the development of the Clinical Development Plan, timelines, and budget for Business Development opportunities.
• Ensures program specific standards (e.g., CRFs, outsourcing specifications, slides, training, templates) are developed and applied across all studies to ensure consistency of clinical dossier.
• Contributes to final analysis and interpretation including the development of clinical trial reports, publications, and internal/external presentations.
• Develops program level financial estimates and contributes to the MLTP.
• Leads program level teams as Co-Chair and/or serves as lead clinical management representative for various meetings including, CRT/GBT/PDC/JDC/Alliance.
• Contributes to the preparation and defense of clinical program documents (investigator brochure (IB)/IMPD, IND/CTA annual reports, Health Authority briefing books and submissions (NDA, MA, NDS etc.), including ongoing maintenance of filings and support of labeling teams).
• Develops strong scientific partnership with key advisors in assigned therapy area to optimize scientific quality/innovation of clinical study design, execution, reporting and publication.
• Leads program-related advisory boards/committees and meetings.
• Serves as contact for Medical Affairs/PBS related to medical information requests, public disclosure of information (e.g., clinicaltrials.gov) and publications strategies.
• Represents assigned programs to senior management and OPCJ and disseminates information and tasks to team members.
• Participates in External Service Provider (ESP) partnership governance and alliance management activities as assigned.
• Assists Senior Director with portfolio level resource planning.
• Gives direction, training, and support to Clinical Management personnel within program/compound team.
• Participates in ongoing review of clinical trial data focusing on data integrity, trending, and consistency.
• Ensures inspection readiness activities are planned and conducted appropriately across program.
• Participate in program-level risk mitigation activities.
• Represent Clinical Management in departmental and cross-functional initiatives, as assigned.
• Leads and/or contributes to assigned departmental, ESP and corporate standardization and continuous improvement efforts.

Qualifications/ Required Knowledge/ Experience and Skills

• Extensive experience in CNS drug development and clinical trial management, including oversight of global studies within psychiatric, neurologic, or other CNS-related therapeutic areas.
• Comprehensive knowledge of clinical operations, drug development process, standard operating procedures (SOPs) and GCP/ICH regulations.
• Thorough knowledge of contract research organizations (CROs), outsourcing, and evaluation of work performed against vendor.
• Advanced understanding of drug development principles and clinical trial implementation and management.
• Significant pharmaceutical industry experience leading and managing clinical development programs in CNS therapeutic areas (e.g., psychiatry, neurology, neurodegenerative disorders, or related CNS indications).
• Demonstrated experience supporting CNS clinical trials from early development through registration is strongly preferred.
• Strong knowledge of global regulatory requirements and compliance, biostatistics, data management, and medical writing.
• Strong communication, organization, planning, analytical, problem solving, and people management skills.
• Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook).
• Good understanding of clinical trial related software (e.g., eCRFs, IRT, CTMS, etc.).
• Ability to travel up to 25%.

Qualifications

• Required: Bachelor’s Degree with a minimum of 14 years of applicable pharmaceutical industry experience, including 10 years of clinical trial management experience.
• Candidates should have substantial experience managing clinical programs within CNS therapeutic areas.
• Previous supervisory experience required.

Benefits

Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.