MedFocus Clinical Development Advisor in Indiana

The Clinical Development Organization, partners with colleagues in Research, Oncology, Biomedicines, and Endo to effectively and efficiently design, plan, and execute clinical trials across all phases of research. Uniting authorities in the clinical development and design, laboratory and data sciences, site engagement, and trial capabilities, we focus on patients, participants, and regulators to deliver novel designs and innovative research approaches. We focus on excellence in bringing these capabilities together and providing diverse career opportunities within global clinical development has established Company as an industry leader in bringing new medicines to patients.

Ensuring the effective and efficient delivery of asset clinical development programs that meet the goals and objectives of the asset strategy and profiles are critical. To make this process successful, we are seeking a Clinical Development Advisor. In this role, you will act as a single point of accountability for cross-functional clinical development of assets and/or programs. Experienced delivering high-quality clinical plans that enable efficient execution, proactively manage risk, and finding opportunities to accelerate clinical development.

As an Advisor in the Clinical Development Organization, we will rely on your expertise to ensure support of key clinical deliverables in support of submission, inspections, and publication. You will effectively mentor, develop, and retain a diverse Clinical Trial Project Management team and staff.

This role is an exciting opportunity to collaborate with asset teams to build bold asset profiles and to partner with the Design Hub to craft viable clinical scenarios. You will work to deliver complete clinical trial packages that enable the rapid transition into trial execution. Ideally, you will:

  • Identify and support novel development approaches to accelerate asset development

  • Champion development of the asset strategy and translate to the clinical plan across Clinical Trial Management staff

  • Demonstrate strong business insight, problem solving and agility to help the team adjust to changes.

You will maintain risk plans during trial implementation in response to new data. To successfully accomplish this task, you will promote broad collaborations. You will account for budget planning, monitoring, and control of the clinical plan/budget. You will also:

  • Represent clinical execution/delivery function at core team meeting ensuring efficient and streamlined processes.

  • Document and communicate effectively appropriate information as needed.

It is key that you nurture a culture of innovation and inclusion. You will engage in continuous improvement across areas such as clinical development, complete trial packages, and process improvement. You will actively engage in project prioritization and state of inspection readiness.

Minimum Requirements:

  • Bachelor degree, preferably in a scientific or health-related field

  • Minimum of 8 years experience in the pharmaceutical industry and/or clinical research

  • 2 years supervisory experience

  • Prior experience in leading complex/cross-functional projects, and/or clinical trials

  • Experience with managing development budgets. Additional Skills/Preferences:

  • Deep understanding of the pharmaceutical drug/device development process

  • Post-graduate degree, e.g., Pharm D, M.S., or Ph.D.

  • A strong knowledge of regulations and guidelines that apply to the conduct of clinical trials.

  • Ability to take and defend tough/unpopular positions

  • Prior project management experience and/or experience leading with multi-disciplinary team

  • Demonstrated ability to translate strategic knowledge and effectively influence the direction of daily operations

Please send resume to jobs@inventivhealth.com

Min Salary: $0.00

Max Salary: $0.00

State: IN