Senior Director, Global Clinical Operations, Oncology Country Head
Janssen R&D is recruiting for a Sr. Director, Global Clinical Operations, Oncology Country Head. This position can be located at any US Janssen R&D Facility. The Oncology Country Head is accountable for strategic and operational management of Oncology clinical research and development activities in a large-size country. This leads to successful country execution of Research and Development and Medical Affairsclinical trials from Ph2 through end of the lifecycle of the compound. This includes resource allocation, adherence to timelines and budget, compliance with relevant Standard Operating Procedures (SOPs), policies, Health Care Compliance (HCC) and local regulatory requirements. The Oncology Country Head shapes and manages local Oncology organizational structure to ensure its optimal efficiency and demonstrates an effective issue management within the country to support the growing portfolio. This is accomplished through leading a large, diverse team of headcount and flex. This role is responsible for line management of Functional Managers and other GCO staff, as required. Ensures alignment of local goals with organizational objectives. Drive innovative solutions and process improvements for the successful planning and execution of the portfolio conducted in the country. This role will partner closely with the Cross-Therapeutic Area leadership and functional leaders from around Global Development. This individual will be a regional Leadership Team member and be involved in the strategic and operational management and decision making within the region.
Responsibilities:
Drive the strategic planning and delivery of the Oncology portfolio in the country. Accountable for building and inspiring a high performing team through ongoing development, performance management and coaching. Ensure the Oncology clinical programs in the country are executed to the highest quality standards according to the protocol, International Guidelines for Good Clinical Practice, international and national SOPs and local procedures and regulations. Help shape and communicate the local and regional vision through leadership and alignment by building informed, aligned, and engaged workforce. Partner with the regional leadership team to drive aligned organizational capabilities to ensure effective study delivery for present and future opportunities including connects/influences external environment. Partner closely with stakeholders such as Therapeutic Area Leads, Medical Affairs and Global Development functions to support successful delivery. Identify strategic improvement opportunities, and sponsor/lead/contribute to the critical improvement projects for regional GCO. Oversee workload for staff to ensure optimal utilization rate of resources. In collaboration with the Business Operations Lead in the region, manages relationship with flex providers to ensure optimal talent engagement to meet the needs of the portfolio. Accountable for an appropriate and timely issue escalation and reporting (suspicion) of fraud, scientific/ethical misconduct and health care compliance breach. Primary point of contact for Health Authority agencies for activities related to clinical operations Country legal representative for GCO related activities (authorized to sign contracts and agreements). Accountable for functional budget and affiliate funding in compliance with relevant financial processes. Shape and maintain strong relationships within Global Development and Local Operating Company (particularly with Medical Affairs). Might participate in Local Operating Company Management Board and Regional Management Teams Contribute to shaping environment for clinical trials in the country (e.g. through involvement in pharma industry associations). Strongly demonstrate leadership behaviors in alignment with J&J Leadership Imperatives. Foster an environment that encourages sharing of ideas, information and best practices (internal and external to the organization). Foster a culture of continuous improvement and innovation within the local GCO team. Define, execute or support of long term strategy in alignment with GCO, Global Development, and Janssen R&D strategies to position the local and global GCO organization for success. Model Credo based culture within the local GCO team. Interview, hire, develop and train staff. Qualifications A minimum of a Bachelor's degree or equivalent is required. An education in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy) is preferred Advanced degree in a scientific discipline and/or Master's degree is preferred A minimum of 10 years of clinical research experience required in pharmaceutical industry, CRO or investigational site. Excellent communication and leadership skills. Proven ability to foster team productivity and cohesiveness. Ability to manage complexity under pressure. Proven track record of people and project management. Strong in hiring, training, developing and evaluation of leaders and people managers. Strong decision-making and financial management skills. Flexibility to work in a rapidly changing environment with the appropriate sense of urgency. Experience in transforming organizations in response to business needs. Effective issue resolution and ability to generate and implement contingency plans for both productivity and quality issues when required. Excellent knowledge of drug development, clinical research operations and regulatory requirements including ICH-GCP, HCC and applicable regulations. Ability to synthesize and evaluate data generated from various reports and sources Demonstrated skills in effective communication with various internal and external stakeholders (e.g. investigational sites, ethics committees, health authorities. etc.). Influential in improving the clinical research environment at a country level. Visionary leader who can shape the organizational culture to improve adoption of future state. Operates under limited supervision. Proficient in English language. Computer literacy. Strong interpersonal and negotiating skills. Excellent organizational skills and the ability to collaborate and handle multiple priorities within a matrix environment. Perform activities in a timely and accurate manner. Primary Location United States-New Jersey-Titusville-1125 Trenton Harbourton Road Other Locations North America-United States Organization Janssen Research & Development, LLC (6084) Job Function R&D Requisition ID 2206051081W
Salary Range:
$200K -- $250K
Minimum Qualification
Account Management, Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
Responsibilities:
Drive the strategic planning and delivery of the Oncology portfolio in the country. Accountable for building and inspiring a high performing team through ongoing development, performance management and coaching. Ensure the Oncology clinical programs in the country are executed to the highest quality standards according to the protocol, International Guidelines for Good Clinical Practice, international and national SOPs and local procedures and regulations. Help shape and communicate the local and regional vision through leadership and alignment by building informed, aligned, and engaged workforce. Partner with the regional leadership team to drive aligned organizational capabilities to ensure effective study delivery for present and future opportunities including connects/influences external environment. Partner closely with stakeholders such as Therapeutic Area Leads, Medical Affairs and Global Development functions to support successful delivery. Identify strategic improvement opportunities, and sponsor/lead/contribute to the critical improvement projects for regional GCO. Oversee workload for staff to ensure optimal utilization rate of resources. In collaboration with the Business Operations Lead in the region, manages relationship with flex providers to ensure optimal talent engagement to meet the needs of the portfolio. Accountable for an appropriate and timely issue escalation and reporting (suspicion) of fraud, scientific/ethical misconduct and health care compliance breach. Primary point of contact for Health Authority agencies for activities related to clinical operations Country legal representative for GCO related activities (authorized to sign contracts and agreements). Accountable for functional budget and affiliate funding in compliance with relevant financial processes. Shape and maintain strong relationships within Global Development and Local Operating Company (particularly with Medical Affairs). Might participate in Local Operating Company Management Board and Regional Management Teams Contribute to shaping environment for clinical trials in the country (e.g. through involvement in pharma industry associations). Strongly demonstrate leadership behaviors in alignment with J&J Leadership Imperatives. Foster an environment that encourages sharing of ideas, information and best practices (internal and external to the organization). Foster a culture of continuous improvement and innovation within the local GCO team. Define, execute or support of long term strategy in alignment with GCO, Global Development, and Janssen R&D strategies to position the local and global GCO organization for success. Model Credo based culture within the local GCO team. Interview, hire, develop and train staff. Qualifications A minimum of a Bachelor's degree or equivalent is required. An education in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy) is preferred Advanced degree in a scientific discipline and/or Master's degree is preferred A minimum of 10 years of clinical research experience required in pharmaceutical industry, CRO or investigational site. Excellent communication and leadership skills. Proven ability to foster team productivity and cohesiveness. Ability to manage complexity under pressure. Proven track record of people and project management. Strong in hiring, training, developing and evaluation of leaders and people managers. Strong decision-making and financial management skills. Flexibility to work in a rapidly changing environment with the appropriate sense of urgency. Experience in transforming organizations in response to business needs. Effective issue resolution and ability to generate and implement contingency plans for both productivity and quality issues when required. Excellent knowledge of drug development, clinical research operations and regulatory requirements including ICH-GCP, HCC and applicable regulations. Ability to synthesize and evaluate data generated from various reports and sources Demonstrated skills in effective communication with various internal and external stakeholders (e.g. investigational sites, ethics committees, health authorities. etc.). Influential in improving the clinical research environment at a country level. Visionary leader who can shape the organizational culture to improve adoption of future state. Operates under limited supervision. Proficient in English language. Computer literacy. Strong interpersonal and negotiating skills. Excellent organizational skills and the ability to collaborate and handle multiple priorities within a matrix environment. Perform activities in a timely and accurate manner. Primary Location United States-New Jersey-Titusville-1125 Trenton Harbourton Road Other Locations North America-United States Organization Janssen Research & Development, LLC (6084) Job Function R&D Requisition ID 2206051081W
Salary Range:
$200K -- $250K
Minimum Qualification
Account Management, Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
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