Senior Director, TA – Exploratory Medicine and Pharmacology

Lilly

28d • $156,000 - $228,800

About The Position

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
Purpose:
The purpose of the Senior Director, Exploratory Medicine and Pharmacology role is to be accountable for program management within a therapeutic area. The purpose is to partner closely with the Clinical Pharmacology Scientific Leads, Medical Directors, and other interested parties to ensure that overall strategy, and clinical plans are aligned to enable both the development and commercialization strategy for allocated assets.
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. Advise your supervision regarding your actual job responsibilities and any related duties that may be required for the position.

Requirements

• Bachelor degree in a science field from an accredited college or university.
• Experience in pharmaceutical drug development process
• 5+ years of experience in managing cross-functional projects and/or clinical trials

Nice To Haves

• Advanced or Post-graduate degree, e.g., Pharm D, M.S., M.B.A. or Ph.D.
• Previous experience with or knowledge of drug development processes in specific therapeutic area(s)
• Solid understanding of regulations and guidelines that apply to drug development
• Excellent oral and written communication skills; able to communicate clearly and succinctly with team members and leadership
• Strong problem-solving skills; able to anticipate and recognize problems, diagnose root causes and take corrective action to prevent recurrence within the team
• Excellent self-management and organizational skills; able to manage workload, set personal and team priorities and adjust as needed. Manage working with a large number of different teams with varying styles, issues, complexity.
• Strong interpersonal and teambuilding skills; able to develop effective teamwork between team members with diverse interpersonal styles; able to deliver effective coaching and feedback
• Strong leadership, interpersonal and influence skills; Ability to provide leadership to others, to appropriately network across a wide variety of functional components, external vendors/partners.
• Strong Discernment; Ability to harness business principles within the team while maintaining a corporate view of the portfolio.
• Flexibility to adjust quickly and effectively to frequent change and altered priorities.
• Applied knowledge and practical experience of project management for cross functional project.
• Strong digital literacy; skilled at using Word, Excel, PowerPoint, and Microsoft Project.
• In depth understanding of the drug discovery and development process
• Scientific background, preferably with direct technical experience in clinical pharmacology or within TA medical

Responsibilities

• Lead the development of the overall clinical strategy within the relevant TA in close partnership with the TA aligned Sr Director
• Lead the strategy for delivery of a platform(s) of assets leveraging similar mechanism of action or disease state within the portfolio.
• Demonstrate expertise and delivery excellence in programs requiring specific or new patient populations and establish partnerships to expand our reach of site networks to enable delivery
• Lead strategy for delivery of complex programs requiring new or novel CRO capabilities
• Leverage and identify acceleration efforts for priority programs requiring seamless delivery across different phases of development
• Lead and contribute in Cross TA projects to drive efficiencies and innovation
• Accountable for ensuring continued alignment of asset strategies with the approved asset strategies and scope.
• Lead the alignment between asset strategies, development scenarios, and partner with operations to align operational feasibility of selected plan/scenario.
• Provide or drive immediate and accurate communication of key decisions/results that have team, asset, and/or organizational impact. Work cross functionally to manage communication about the asset inside + as appropriate, outside of the company.
• Effectively manage collaborator communication to enable streamlined portfolio management and execution.
• Provide project management and leadership for special initiatives that are cross functional in nature and advance EMP drug development capabilities.
• Key resource for portfolio and cross-asset shared learning, process improvement, and identification and incorporation of guidelines into future iterations of processes, tools, training, or guidance.
• Mentor and coach others in the development of project management skills and knowledge in drug development/drug discovery.
• Be seen as experts in integrated drug development, drug discovery and project management within and external to the department.
• Serve as a deep technical expert in clinical pharmacology subject areas and project/portfolio management and evaluate and pilot, if appropriate, innovative project management processes, tools.
• Leads the development of the clinical asset strategy for phase 1 using quality decision making principles.
• Understands assigned therapeutic area including trial designs, risks and execution challenges and procedures.
• Provides consultation to the project team for clinical and regulatory documents such as study protocols, Investigator Brochures (IBs), risk profiles, annual reports, briefing documents, New Drug Applications (NDAs), safety updates, clinical study reports (CSRs), abstracts, publications, and manuscripts.
• Stays up to date with current body of knowledge of relevant disease states/targets, competitors, and industry trends and protocols.
• Maintains knowledge of operational requirements to effectively plan exploratory and bio pharmaceutics clinical development studies and submissions e.g., FHD (First Human Dose) requirements, detail of operations to deliver critical path studies and submissions.
• Leads and has expertise in the implementation and integration of clinical project management processes and tools.
• Works with Third Party Organizations (TPOs) to implement the defined clinical strategy, being responsible for key trial results.
• Develops and maintains up-to-date clinical plan timelines and process maps (if appropriate) ensuring communication of progress to the broader molecule team.
• Partners with the financial organization, cross-functional partners, and geographies, to develop and manage the overall clinical budget for the molecule level book of work including initiation and management of the change process.
• Proactively identifies and communicates clinical risk assessment and mitigation/contingency plans within team and to functions, affiliates, and leadership.
• Accountable and responsible for oversight of clinical trial operations and delivery of clinical project achievements on time, on budget
• Create and manage implementation timeline and clinical trial activities
• Involved in selection process and management of vendors, ensuring day to day oversight for operational results of external network of vendors to ensure on time and on budget clinical project results
• Serves as the point of contact for the global clinical team, to resolve clinical implementation issues (internal and external), lead risk assessments and contingency planning, and convey details across and upward
• Partner with regulatory and medical to ensure safety management and monitoring processes are implemented
• Influences and works with quality approach across the clinical team by documenting key decisions, actions and key modifications in clinical scope, resources, and timeline; ensuring accurate collection and communication of clinical metrics; ensuring archival of all relevant clinical information at the termination of a project and as appropriate throughout the project.
• Manages key partnerships and interactions/integration with the clinical team, including leadership in governance forums (if applicable).
• Effectively and reliably communicates and influences at all levels across the organization clear and concise information to enable decision-making by team and governance/Partners
• Collaborates effectively with colleagues at all levels; able to work with, and deliver, through others.
• Skilled at working through ambiguity and effective problem-solving/solution-oriented skills to help develop and evaluate molecule level strategies from lead to legacy.
• Successful in persuasion, influence, and negotiation skills in a matrix environment.
• Champions spirit of learning agility, critical thinking, and the ability to think differently to incorporate new learning
• Contributes to the development of others by being an active source of constructive coaching and feedback to co-workers.
• Recruits, develops, and retains a diverse and highly capable workforce.
• Ensures robust individual training plans and timely completion of required training for direct reports.
• Supports and enables talent identification and career development that reflects an end-to-end mindset and demonstrates judgement-based decision making.
• Contributes to succession planning, talent assessment and performance/promotion processes. Ensure high talent staff are appropriately rewarded and developed.
• Models behaviors and establish an environment where performance and results are valued, and where individuals are learning and growing developmentally.
• Seek opportunities to reward and recognize individuals and teams.
• Leads team workload based on portfolio prioritization, regional requirements, and individual level of expertise, and address implications to overall resource management and strategies.
• Supports and encourages a culture of innovation and the learning that comes from new/novel approaches to clinical development and models’ inclusivity to ensure diverse voices and ideas are heard and considered.
• Coaches and mentors department personnel, and as needed, cross-functional members, in order to affect development and growth of all team members.

Benefits

• 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).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level