Director, Clinical Management Early Phase, rare/specialty disease

Otsuka America Pharmaceutical Inc.; Hartford (CT); Remote; USD 180,000 - 260,000; Full time

Benefits offered by this job

Comprehensive medical, dental, vision

401(k) match

Generous paid time off

Tuition reimbursement

Job summary

Otsuka America Pharmaceutical Inc. is seeking a Director of Clinical Management to oversee operational strategy and management of clinical programs.

You will coordinate with internal departments and ESPs to plan, execute, and complete studies in compliance with ICH, GCP, and SOPs within budget and timelines. Responsibilities include developing the Global Clinical Development Plan, leading teams, and supporting regulatory submissions.

Qualifications

• Comprehensive knowledge of clinical operations, drug development process, SOPs and GCP/ICH regulations.
• Thorough knowledge of CROs, outsourcing, and evaluation of SOW.
• Advanced understanding of drug development and clinical trial management.
• Strong regulatory, biostatistics, data management, and medical writing knowledge.
• Excellent communication, organization, planning, analytical and leadership skills.
• Proficient with MS Office and trial software like eCRFs, IRT, CTMS.
• Ability to travel up to 25%.

Responsibilities

• Provide scientific clinical research and operational expertise for Global Clinical Development Plan.
• Oversee development of Clinical Development Plan timelines and budgets for opportunities.
• Ensure program-wide standards across studies for consistency of clinical dossiers.
• Contribute to clinical trial reports, publications, and presentations.
• Lead program-level teams as Co-Chair or lead clinical management representative.

Skills

Clinical operations

GCP/ICH regulations

CROs & SOW

Regulatory compliance

Biostatistics

Data management

Medical writing

Leadership

Travel readiness

Education

Bachelor's degree with 14+ years pharma

Advanced degree

Job description

Remote

Full time

R11844

Job Summary

In collaboration with the Senior Director of Clinical Management, the Director is responsible for the operational strategy and management of Otsuka clinical programs, including coordination with other relevant parties (e.g., other Otsuka departments, external service providers (ESPs), etc.). Responsibilities include the planning, execution, 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.

Job Description

• 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.
• 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.
• Supports the design & implementation of a program level HEOR strategy, including endpoint development where necessary.
• 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.
• Participates 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.
• Performs other duties, as assigned.

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%.

Educational Qualification Required

• 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

Competencies

• Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
• Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.
• Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
• Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
• Respectful Collaboration - Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.
• Empowered Development - Play an active role in professional development as a business imperative.

Application Deadline

This will be posted for a minimum of 5 business days.

Company benefits

Company 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.

Disclaimer

This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.

If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting [e-mail] .

Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: “Otsuka–people creating new products for better health worldwide.” In the U.S., Otsuka is comprised of two companies, Otsuka America Pharmaceutical, Inc., and Otsuka Pharmaceutical Development & Commercialization, Inc., that share a deep commitment to the development and commercialization of innovative products in the spaces of neuroscience, nephrology, and digital medicine.

Driven by our purpose to defy limitation, so that others can too, we have an unwavering belief in doing more and transcending expectations. In going above and beyond—under any circumstances—for patients, families, providers, and for each other. It’s this deep-rooted dedication that drives us to uncover answers to complex, underserved medical needs, so that patients can push past the limitations of their disease and achieve more than they thought was possible each and every day.

OPDC and OAPI are indirect subsidiaries of Otsuka Pharmaceutical Company, Ltd., which is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 34,400 people worldwide and had consolidated sales of approximately USD 14.2 billion in 2023.

We invite you to explore our open positions for an opportunity to join our 2,200 colleagues in the U.S. whose passion for our mission and pride in our company have earned us certification as a Great Place to Work by the Great Place to Work Institute.