Director, Clinical Management Early Phase, CNS

About the role

The Director is responsible for the operational strategy and management of Otsuka clinical programs, including coordination with other relevant parties.

Responsibilities

• Planner, executor, and completion of clinical programs according to applicable regulations and guidance; ICH Guidelines, Good Clinical Practices (GCP), and Otsuka SOPs, within agreed upon timelines and budget.
• Provides scientific clinical research and operational expertise in the development of overall strategy and objectives of the Global Clinical Development Plan (GCDP).
• 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.
• Leads development of clinical sections of regulatory documents (i.e., Investigators’ Brochures, briefing books, submission dossier, and responses to Health Authorities questions) and inspection readiness programs, where appropriate.
• 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.
• May have supervisory responsibilities including: Coordinating the training and onboarding of new employee(s) on corporate culture, corporate goals/vision and departmental policies and processes.
• Assuring compliance with departmental, SOP, compliance, and corporate training.
• Ensuring assigned staff have access to all required materials, systems, and training to complete job responsibilities.
• Setting clear performance expectations and individual development plans and providing specific and frequent feedback to the employee on his/her performance.

  Qualifications/ Required Knowledge/ Experience and Skills

  • 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 Statement of Work (SOW).
  • Advanced understanding of drug development principles and clinical trial implementation and management.
  • 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

  • Bachelor’s Degree with a minimum of 14 years of applicable pharmaceutical industry experience including 10 years clinical trial management experience.
  • Previous supervisory experience.

  Preferred

  • Advanced Degree.

  Pay

  $186,489.00 - $278,875.00, plus incentive opportunity: The range shown represents a typical pay or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.

  Schedule

  Full-time.

  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.

  Contact Information

  For more information about Otsuka and our benefits offerings, visit: https://www.otsuka-us.com/careers-join-otsuka.

  Disclaimer

  Otsuka will not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka’s application portal without a valid written search agreement in place for the position will be considered Otsuka’s sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. For further information regarding Otsuka’s policy on recruitment fraud, please contact the FBI through the Internet Crime Complaint Center at: https://www.ic3.gov, or your local authorities.