Director Operational Risk Jobs in Indianapolis, IN

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Purpose:

The Clinical Development Program Lead (CDPL) is the single point of accountability for the cross-functional global clinical development of a given asset or portfolio of assets. As such, the CDPL ensures asset profiles and strategies are developed and clearly defined and leads effective and efficient development and delivery of asset clinical plans. The CDPL achieves this through strong partnerships and influence with asset team leadership (e.g. team leader, COO, medical director, lead CRP) and cross-functional team members from across the CDDA. The CDPL is accountable for developing and maintaining expertise in their therapeutic area including current and evolving clinical paradigms and knowledge of the competitive landscape. The CDPL is also accountable for high quality, efficient execution of the clinical plan, including proactive operational risk management, tracking progress-to-plan, and identifying acceleration opportunities. Finally, the CDPL is accountable for managing cross-functional support of key clinical deliverables in support of submissions, inspections, and publications.

The Clinical Development Program Lead reports to the Associate Vice President within their assigned therapeutic area.

Primary Responsibilities:

This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.

Clinical Planning

• Single clinical development point of accountability for assigned asset(s) from strategy and profile development through to submission, approval and post-launch support.
• Collaborates with and influences asset teams to create competitive profiles and partners across the CDDA to ensure the creation of viable clinical scenarios. Drives communication ofoptions with the assetteam and clinical plan decision making.
• Identifies and supports novel development approaches that have the potential to accelerate the development of assets.
• Champions the asset strategy and drives translation of the strategy to the Clinical Development Trial Lead staff. Ensures that all clinical functions understand the strategy, timelines and risks.
• Demonstrates strong business acumen, problem-solving skills, and agility to help team plan for contingencies, and adjust to changes.
• Demonstrates a strong understanding of clinical paradigms and the external competitive landscape and how competitor trials are designed, etc.

Clinical Execution/Clinical Delivery

• Partners across the CDDA to ensure delivery of the complete trial package (scope, timeline, budget and risk management) that enables the rapid transition into trial execution.

• Ensures the risk plans are developed and maintained during clinical plan implementation in response to new data and changes in the environment.
• Promotes cross-functional and cross-phase collaboration to drive efficient implementation.
• Represents clinical functions at asset team core meetings. Ensures streamlined and efficient project and meeting management.
• Accountable for budget planning, monitoring and control of the overall clinical plan and budget
• Documents and communicates key decisions, actions, and modifications in clinical scope, resources, timeline and risks.

Demonstrated Leadership and Influence

• Communicates and aligns cross-functional resources based on portfolio prioritization inclusive of being flexible across therapeutic areas.
• Maintains compliance culture and a state of inspection readiness for clinical research activities.
• Models judgement-based decision making to navigate compliance and quality requirements.
• Responsible for identification of continuous improvement opportunities in the spirit of streamlining the efficiency and effectiveness of conducting clinical trials and non-trial work.

• Supports and encourages a culture of innovation and the learning that comes from new/novel approaches to clinical development.
• Creates and models an inclusive culture to ensure diverse voices/ideas are considered.
• Serves as mentor for clinical development managers, clinical trial project managers and others in the CDDA.

People Management (as applicable, may be variable over time)

• Recruit, develop, and retain a diverse and highly capable workforce.
• Ensures appropriate oversight of team deliverables through streamlined and efficient project management.

Minimum Qualification Requirements:

• Bachelor's degree, preferably in a scientific or health-related field
• Minimum of 8 years' experience in the pharmaceutical industry and/or clinical research
• Broad understanding of the pharmaceutical drug/device development process
• Prior experience in managing complex/cross-functional projects, and/or clinical trials
• Experience with managing development budgets.
• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or Visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1

Other Information/Additional Preferences:

• Post-graduate degree, e.g., Pharm D, M.S., or Ph.D.
• Early oncology Clinical Development experience
• 2 years previous supervisory experience (as applicable)
• A strong knowledge of regulations and guidelines that apply to the conduct of clinical trials.
• Demonstrated ability to take and defend tough/unpopular positions
• Prior project management experience and/or experience leading with multi-disciplinary team
• Demonstrated ability to take strategic knowledge and effectively influence the direction of daily operations
• This is not a Remote based role. Candidates will be required to work onsite at either our Stamford, CT facility or Corporate Center in Indianapolis, IN, in a hybrid capacity. Relocation assistance can be provided

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women's Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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