Ortho Clinical Diagnostics, Inc. Clinical Affairs Lead in Rochester, New York
|Clinical Affairs Lead|
|Job Country||United States|
|Category||Medical Affairs and Professional Education|
Ortho Clinical Diagnostics (Ortho) is a global leader of in vitro diagnostics. Ortho serves two primary industries in the medical field: clinical laboratories, by producing platforms and assays that test for a variety of diseases, conditions, and substances; and immunohematology, by providing the means to ensure blood transfusion recipients receive appropriate and compatible blood.
With a history of more than 75 years, Ortho is a pioneer in life-impacting advances in diagnostics. Worldwide across hospitals, hospital networks, blood banks and labs, Ortho’s high-quality products and services enable health care professionals to make better-informed treatment decisions. Headquartered in Raritan, NJ, Ortho Clinical Diagnostics has approximately 4,300 employees serving customers in more than 120 countries.
Ortho is recruiting and retaining the best and brightest around the world. People, who are performance driven, want to make a difference and who help Ortho grow their leadership position in a changing marketplace. The power to reimagine starts with empowered people, who are empowered to grow and given the chance to succeed in ways they hadn’t thought possible before.
Ortho’s purpose is simple: to improve and save lives with diagnostics. They do that by reimagining what’s possible. It’s what defines them. It’s the Ortho difference.
Ortho is an independent company, sponsored by The Carlyle Group, one of the world’s largest and most successful investment firms. The company's executive leadership team has extensive diagnostic experience and a strong heritage of driving market change and innovation. Ortho is a strong brand with solid positions in attractive, growing segments and regions.
Ortho Clinical Diagnostics is committed to improving and saving lives with diagnostics. To do this we hire people who share this dream and are ready for new adventures. As a valued team member, you will carve your own career path and be part of building this company stronger and better than ever before. There is no limit to the experiences, opportunities and new directions you will have access to here at Ortho Clinical Diagnostics. More importantly, you will be driving the surge of a whole new direction in important medicine. That’s something we can all take pride in as we take this journey together.
Ortho is known in the industry as a leader in customer service and support. Deeply understanding and exceeding the needs of our clinical lab, hospital and blood bank customers is what we do. It’s who we are. If you join Ortho, no matter what your role, you will be expected to keep that Customer Excellence focus in your work.
As the company continues to grow, we are seeking a Clinical Project Group Leader who will lead the planning and oversight of clinical development activities to support the validation of assigned assays. This position is responsible for interpreting medical, scientific and clinical strategy and driving clinical development and trial management of multiple moderate to highly complex clinical programs including, but not limited to, the planning, implementation, oversight, project management and completion of clinical trials conducted by Clinical Affairs or Contract Research Organizations (CRO). The Clinical Project Group Leader will drive results through inspired leadership with a focused and disciplined approach to clinical development that is consistent with best practices in the industry. He/she will work collaboratively with clinical, product management, regulatory, and R&D teams to design, execute and deliver clinical programs.
• Lead the design, planning, development and monitoring of sample collection programs to support the validation of biomarkers for in vitro diagnostic assays and to support assay product development, regulatory market application submissions of new or reformulated IVD products or additional indications. Independently plans and executes clinical studies and applies expertise in collection or acquisition of clinical samples.
• Independently develop and present strategies to ensure that the clinical sample collections effectively support the overall assay product development program objectives within approved budgets and committed timelines. Define, track and report schedule attributes such as durations, interdependencies, milestones, critical path and other key deliverables including efficiency and effectiveness of plans and staff.
• Manage operational plans and timelines to achieve on-time enrollment and study completion. Lead, coordinate and oversee adjudication activities.
• Identify, qualify, select and manage external service providers responsible for large budgets. Responsible for management of vendor performance to ensure adherence to scope of work within timelines and budget at a task level. Proactively assess potential risks to the study and propose mitigation plans.
• Identify and facilitate academic collaborations and interactions with key opinion leaders that are aligned with company goals. Actively participate in external communication and collaborations with thought leaders in clinical development ensuring the highest level of competency and professionalism in all activities and that all projects are aligned to the needs of the customers and business, and that timelines are met.
• Ensure compliance of program conduct and study documentation practices with company policies and procedures. Actively participate in establishing best practices through strategic planning; training and writing/editing appropriate documentation.
• Participate on project teams and supervise the participation of direct reports. Provide project leadership and assign projects or activities to individual contributors.
• Knowledge of regulations and standards (CFR, GCP, ICH, ISO, QSR, etc.)
• Ability to deal with ambiguous situations, perform work effectively with a high degree of independent judgment without direct oversight with multi-level teams, manages multiple projects and resources in a fast paced and changing environment.
• Ability to proactively identify and manage risks and issues (including mitigations and contingencies) to ensure cost effective timely delivery of the project including escalation.
• Maintain knowledge of the medical, biological and technical/analytical aspects relevant to clinical programs.
• Ability to provide critical thinking and leadership when issues arise during execution of clinical studies.
• At least 3 years of demonstrated individual/team supervisory and management experience with budgetary responsibility is preferred.
• Demonstrated track record of leadership of complex clinical sample collections. Directly lead global clinical sample collections used in support of FDA 510k, PMA and BLA submissions & CE declarations. Demonstrated prior experience with strong client and vendor relationship management skills.
• Demonstrated and effective interpersonal, communication and negotiation skills for a wide variety of audiences.
• Demonstrated experience in computer skills to include Microsoft Word, Excel and basic templates.
Travel up to 25% on an annual basis.
Work visa sponsorship is not available for this position
Ortho Clinical Diagnostics believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. Ortho Clinical Diagnostics is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform their job related duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at email@example.com.
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"At Ortho Clinical Diagnostics, we are proud of the empowering, inclusive and innovative culture we are growing. Our team is passionate about our work, and brings deep knowledge, industry experience and diverse thinking that drive results, making Ortho a place to grow your career.
Ortho Clinical Diagnostics is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other characteristic protected by law."