Johnson & Johnson Careers
Head, Medical Affairs Operations, Clinical Operations - Americas
Requisition ID: 8807190305
Janssen R&D is currently recruiting for a Head, Medical Affairs Operations, Clinical Operations for the Americas. This position will be located in Titusville and will report into the Vice President, Global Medical Affairs Operations.
This position is accountable to deliver all Company-sponsored clinical trials and company-supported Investigator-Initiated studies (IIS)/ Collaborative studies for the Pharma Medical Affairs units based in the Americas Region (United States, Canada and Latin America), executed with high quality and meeting all regulatory, Company and ethical requirements, according to timelines and budgets and with right resourcing overall.
This role calls for strong collaboration with the Medical Affairs function, with interfacing groups within Global Clinical Development Operations (GCDO) and with other supporting functions (e.g. legal, human resources, procurement…); excellence in communication is essential.
To perform this role requires an ability to understand the broad range of needs across the company medical affairs portfolios and creatively work with the medical organisation to investigate and propose state-of-the-art operational solutions to address medical evidence generation needs.
A focus on and appetite for innovation and piloting new ways of working in a changing world will be important for the future, particularly with respect to understanding and implementing new means of evidence generation in a growing data environment.
This leader is responsible for oversight of the performance as well as enabling differentiated development of all employees within the department, with a goal of enabling and preparing the organization for today and the future. The role also is responsible to create and maintain an environment that welcomes diversity and ensures a respectful and secure working atmosphere where innovation is actively embraced and encouraged.
This role contributes to setting the global vision for Medical Affairs Operations (MAO), participating to the delivery of all departmental goals expressed in areas of Excellence in Delivery, Unleashing the Potential of our staff, becoming the Partner of Choice with key partners and Innovating for Tomorrow
- Strategic interaction with Medical Affairs Vice-Presidents (MA VPs) and Therapy Area (TA) leaders; point of contact to discuss new programs/trials. Active involvement to provide the operational voice to the Integrated Evidence Generation Plans (IEGP) managed by the medical affairs functions (MAF). Encourage inclusion of patient and investigator input at early stages in program design.
- Organize optimal and timely proposals to MAF partners for the execution of study programs with estimates and proposed vendor agreements that specify realistic milestones, budget and outcome targets. Critical analysis and dialogue with the MAF on feasibility aspects of studies, applying the most up-to-date data analytics capabilities.
- Be the single point of accountability for the execution of all in-scope Medical Affairs study activities in the Americas region, from support of the protocol development to final clinical report, as well as any follow-through communications to the investigators / patients.
- Ensure all MA activities can be executed in line with regulatory, Company policy and SOP and ethical requirements, according with agreed timelines, within agreed budget, including opportunities for enhancing patient and investigator involvement and engagement at all steps of the process.
- Ensure appropriate resourcing for portfolio activities in the region with strategic outsourcing as needed, optimizing supplier relationships and the operational agreements under which we collaborate, working with the Strategic Partnerships group.
- Support optimal performance and development of the employees within the department; including clear goals and objectives to be aligned with the regional Medical Affairs and GCDO/MAO G&Os, development conversations and support focused on individual and team needs, performance management, talent and succession planning and ongoing active feedback. This role is expected to model the behaviors that are aspired to in the GCDO values.
- Champion Medical Affairs Clinical Operations innovation, sharing expertise, encouraging experimentation and appropriate risk management and actively communicating learnings within the organization.
- Build and maintain optimal relationships with key partners, including but not limited to:
- Local, Regional and Global Medical Affairs Functions
- Medical Affairs Operations Leadership team members
- All GCDO enabling functions and leadership, with focused and regular connections and alignment with Global Clinical Operations (GCO) and Portfolio Delivery Operations (PDO)
DECISION-MAKING AND PROBLEM-SOLVING:
- Demonstrates expertise in strategic planning, development and leadership of organizations, including making timely decisions for the management of the departmental and initiatives, overall resource management, portfolio management and people management.
- Monitors program progress and resolves critical issues (refers to the appropriate functions).
- Experience and demonstrated success in fostering a motivating and productive team environment.
- Demonstrates knowledge of - and ability to interpret for decision-making - global and relevant regional or local regulatory requirements related to the different Medical Affairs trial types, and general operational issues.
- Demonstrates knowledge of Clinical R&D, Medical Affairs, and Commercial organisations and issues.
- Applies process (including planning, risk management and change management) to ensure that activities are executed according expectations and with reliable results.
- Manages complexity and demonstrates innovative approaches to change management.
- Interacts with all levels of management and influences decision-making through constructive and authentic influencing
- Contributes to the design, development, modification, and evaluation of the Clinical Operations processes and standards to improve the implementation of clinical trials
- Demonstrated ability to network, build relationships and interact with global team members and diverse styles of management, employees and external partners
- Comfortable with addressing and actively and constructively manages conflict
- A minimum of a Bachelor’s degree is required
- An advanced degree in a scientific discipline (MD, PhD) is preferred
- A minimum of 12 years of experience in the pharmaceutical industry is required
- A minimum 3 years of close working with or experience in Medical Affairs or a similar position is preferred
- A minimum of 5 years of designing and / or executing clinical trials, strategic planning, and specifically in the management of clinical trial operations in the pharmaceutical or biotech industries is required
- Demonstrated experience managing and mentoring clinical team members.
- Effective leadership skills and proven ability to foster team productivity and cohesiveness.
- Excellent communication skills and the innate flexibility to work in a rapidly changing and growing organization.
- In addition, the following competencies are required: collaboration and teaming, integrity and credo based-actions, results and performance driven, sense of urgency, and managing complexity.
- Demonstrated ability to manage challenging situations with open, inclusive, creative and collaborative problem-solving skills
- A limitless desire to learn and grow
- Other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility
United States-New Jersey-Titusville-
Janssen Research & Development, LLC. (6084)
Clinical Trial Coordination