Director of Clinical Affairs- Raritan, NJ, Rochester, NY, San Diego, CA, Athens,
Raritan, NJ  / Rochester, NY  / Athens, OH  / San Diego, CA ...View All
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Posted 19 days ago
Job Description
The Career Potential

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.

The Opportunity

As we continue to grow, we are seeking aDirector of Clinical Affairs to be responsible for defining and executing clinical trials that support regulatory submissions for QuidelOrtho new product development and evidence generation for all QuidelOrtho products worldwide. A scientific and operational leader, the Director of Clinical Affairs generates innovative clinical strategies and drives decisions to create, maintain, and execute clinical development plans. He/She will be responsible for clinical trial budget forecast and management and will apply his/her in-depth knowledge of clinical trial design in IVD studies, strategic outsourcing expertise, partnership management, and exceptional team leadership capabilities to achieve QuidelOrtho's business objectives. The Director of Clinical Affairs will be responsible for critical clinical trial documents including study strategy, design, protocols, and reports. He/She will occasionally act as the internal expert/consultant recognizing clinical requirements and expected trial costs in potential business development opportunities.

This position plays a critical role in partnering with product management, the R&D development teams, Medical, Clinical Operation, and Regulatory, as well as leading the Clinical Affairs team. He/she is capable of balancing risk, assessing progress, and allocating resources based on the changing business needs. He/she will serve as the day-to-day supervisor, coach, and mentor for the Clinical Affairs team, offering direction to team members, assessing performance, and training needs, and creating a climate in which individuals are empowered and motivated to do their best.We are looking for a battle-tested leader in this space. This position can be located in Raritan, NJ, Rochester, NY, San Diego, CA, or Athens, OH or can be a remote position.

The Responsibilities
  • Provides subject matter expertise for IVD clinical strategy, clinical trial design, and operations to ensure studies and programs are delivered on time, within budget, and with a high-quality outcome.

  • Drives performance and delivers outcomes with external stakeholders (staffing agencies, regulatory authorities, etc.)

  • Creates and maintains key clinical trial documents such as study protocols and reports.

  • Works in close collaboration with project teams to assess early key project risks and clinical requirements for successful trial execution.

  • Collaborates with and strongly influences internal stakeholders (marketing, R&D, Medical, Clinical Operation, Regulatory, HCC, etc.) and global functional areas in managing the study.

  • Mentors, trains, and guides internal team members and experienced contractors.

  • Trains stakeholders on required procedures and the role of contractors.

The Individual
  • B.A. degree required; Master's degree preferred.

  • MD or Ph.D. is preferred.

  • Minimum of 8 years of Clinical Affairs / Clinical Operations experience. Experience in a leadership role is required.

  • Must have a minimum of 3 years of supervisory experience.

  • Demonstrated experience with a minimum of 4 successful clinical trials is highly preferred.

  • Registration of clinical trial management and clinical trial design experience required.

  • Experience working with key opinion leaders and principal investigators in complex medical conditions and translating their expertise into efficient and lean clinical trial plans.

  • Proficiency in interacting with hospital systems and clinical trial coordinators, and proven ability to fast track through Institutional Review Boards by relationship, reasoning, proficiency, planning, and staying within budgeted parameters are essential traits of this proven leader.

  • In-depth knowledge of Good Clinical Practices (GCPs) and the current regulations related to the clinical trial execution is preferred.

  • Experience with regulatory authority audits globally is preferred.

  • Excellent written and oral communication skills are required.

  • Excellent organization, negotiation, and presentation skills are required.

  • Must have the ability to collaborate with and strongly influence internal stakeholders (marketing, R&D, Medical, Regulatory, HCC, etc.)

  • Experience collaborating with external stakeholders (staffing agencies, regulatory authorities, etc.) is required.

  • Demonstrated ability to exercise a highly complex level of independent judgment and execute work independently with limited direction while establishing the priorities of the Clinical Affairs Team required.

  • Demonstrated quality-oriented mindset and consistent attention to details

  • Strong analytical skills preferred

Colorado State Posting Details: This position's starting salary is between $120,000 and $253,000 per year, and it is bonus eligible. Salary will be determined by the education, experience, knowledge, skills, and abilities of the candidate, in addition to internal equity and alignment with market data. Ortho offers a comprehensive benefits package, including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, paid time off (including paid sick time) and paid holidays. All benefits are non-contractual, and Ortho may amend, terminate, or enhance the benefits provided, as it deems appropriate.

EOE/AA Disability/Veteran

#LI-Remote



"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."

 

Job Summary
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Experience
8+ years
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