Associate Director, Clinical Operations - Study Start-up, US Oncology

Johnson & Johnson Innovative Medicine•Hopewell Township, NJ

3d•$137,000 - $235,750•Hybrid

About The Position

The Associate Director, Clinical Operations - Study Start-up, US Oncology will be accountable for the operational management and successful country execution of all phases of clinical trials within the assigned therapeutic area(s), or specific role(s), including resource allocation, adherence to timelines and budget, compliance with relevant Standard Operating Procedures (SOPs), policies, Health Care Compliance (HCC) and local regulatory requirements. The Associate Director will support the Country Head in shaping and managing local organizational structure to ensure its optimal efficiency. This individual will be responsible for line management of Local Trial Managers (LTMs), Site Managers (SMs), Clinical Trial Assistants (CTA) and/or other DU staff (including Manager, Clinical Operations), as required. May also mentor less experienced Functional Managers (FM)/Clinical Research Managers (CRM) and assume cross-border oversight, if required. Oversee staff performance, development, training, project assignments, workload distribution and support issue resolution with direct reports. Ensure alignment of local goals with organizational objectives. Drive innovative solutions and process improvements for the assigned therapeutic area(s), country, and DU/Global Development (GD) overall.

Requirements

Minimum of a Bachelor's degree is required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy)
Minimum of 8 years of clinical research experience within the pharmaceutical industry, Contract Research Organization (CRO) and/or investigational site
People management experience
Knowledge of the drug development process, clinical research operations and regulatory requirements, including ICH-GCP, Health Care Compliance (HCC) and applicable regulations
Financial management skills (e.g., budgeting, forecasting, risk analysis, etc.)
Must have excellent communication, interpersonal and leadership skills, with the proven ability to foster team productivity and cohesiveness
Must have strong decision-making, issue resolution and negotiating skills
Must have flexibility to work in a fast-changing environment and operate under limited supervision
The ability to evaluate data generated from various reports and sources
The ability to effectively communicate with various internal and external stakeholders (e.g., investigational sites, ethics committees, health authorities, etc.)
The ability to collaborate with all levels of management and handle multiple priorities within a matrix environment

Nice To Haves

Experience in the Oncology (Solid Tumor and/or Hematology) Therapeutic Area
Experience managing direct reports

Responsibilities

Provide line management to direct reports, including setting goals and objectives, performance evaluation and talent development.
Evaluate and forecast resource needs for assigned portfolio and/or other specific areas of responsibility, as required and agreed with local DU management accordingly.
Deployment of the One Delivery Model through collaboration and oversight of vendors.
Accountable for the acquisition of new talents and development of human resources.
Guide direct reports in issue resolution and communication with involved stakeholders.
Lead organizational changes and effectively communicate on priority shifts as required.
Review and approve expenses in compliance with the company policies.
Demonstrate leadership behaviors in alignment with Johnson & Johnson Leadership Imperatives.
Foster an environment that encourages sharing of ideas, information and best practices (internal and external to the organization).
Provide coaching and mentorship as needed, including conduct of accompanied site visits as appropriate.
Define, execute or support long-term strategy in alignment with DU, GD and Johnson & Johnson Innovative Medicine (JJIM) R&D strategies to position the local and global DU organization for success.
Oversight of execution and monitoring of clinical trials through all phases (from feasibility to close-out) and ensuring inspection-readiness within assigned therapeutic area(s) and/or other areas of responsibility, as required.
Accountable for ensuring relevant operational objectives are met in conformance to International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP), relevant SOPs and other procedural documents.
Accountable for appropriate and timely issue escalation and reporting (suspicion) of fraud, scientific/ethical misconduct and health care compliance breach.
Contribute to Corrective and Preventative Action (CAPA) and issue resolution in accordance with required timelines.
Shape and maintain strong relationships within local DU department and Local Operating Company (particularly with Medical Affairs) and other key internal and external stakeholders.
Develop country capabilities for an effective study placement within assigned therapeutic area(s) and/or other areas of responsibility, as required.
Accountable for robust feasibility process and oversight of site selection to deliver on country commitments within assigned therapeutic area(s) and strategic goals.
Review operational and quality metrics regularly and drive follow-up actions as appropriate.
Drive innovative solutions and process improvements for the assigned therapeutic area(s), country, and DU/GD overall.
Foster a culture of continuous improvement and innovation within the local DU team.

Benefits

medical, dental, vision, life insurance, short and long-term disability, business accident insurance, and group legal insurance
consolidated retirement plan (pension) and savings plan (401(k))
long-term incentive program
Vacation –120 hours per calendar year
Sick time - Sick time - 40 hours per calendar year; for employees who reside in the State of Washington – 56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member
Caregiver Leave – 10 days
Volunteer Leave – 4 days
Military Spouse Time-Off – 80 hours
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year