Senior Director, TA – Exploratory Medicine and Pharmacology
Eli Lilly and, Indianapolis, IN, United States
Overview
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 put people first and strive 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 role partners 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. Advise supervision regarding actual job responsibilities and related duties that may be required for the position. Lead the development of the overall clinical strategy within the relevant Therapeutic Area (TA) in close partnership with the TA-aligned Sr Director.
Lead the strategy for delivery of a platform 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 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 the 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 and 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.
Be a 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 and tools.
Scientific and Therapeutic Area Expertise
Lead the development of the clinical asset strategy for phase 1 using quality decision making principles.
Understand assigned therapeutic area including trial designs, risks and execution challenges and procedures.
Provide consultation to the project team for clinical and regulatory documents such as study protocols, Investigator Brochures (IBs), risk profiles, annual reports, briefing documents, NDAs, safety updates, CSRs, abstracts, publications, and manuscripts.
Stay up to date with current knowledge of relevant disease states/targets, competitors, and industry trends and protocols.
Maintain knowledge of operational requirements to effectively plan exploratory and bio pharmaceutics clinical development studies and submissions, e.g., First Human Dose requirements and operational detail to deliver critical path studies and submissions.
Clinical Project Management
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, 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 the team and to functions, affiliates, and leadership.
Clinical Delivery: Accountable for oversight of clinical trial operations and delivery of clinical project achievements on time and on budget.
Create and manage implementation timelines and clinical trial activities.
Involved in selection process and management of vendors, ensuring day-to-day oversight for operational results of an external network of vendors to ensure on-time and on-budget results.
Serves as the point of contact for the global clinical team to resolve implementation issues, 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.
Communication and Team Management
Influences and works with a quality-focused approach across the clinical team by documenting key decisions, actions and modifications in scope, resources, and timeline; ensure accurate collection and communication of clinical metrics; archive all relevant information at project termination and as appropriate.
Manages key partnerships and interactions with the clinical team, including leadership in governance forums (if applicable).
Effectively and reliably communicates to enable decision-making across the organization.
Leadership
Collaborates effectively with colleagues at all levels; able to work with and deliver through others.
Skilled at working through ambiguity and problem-solving to develop and evaluate molecule-level strategies from lead to legacy.
Successful in persuasion, influence, and negotiation in a matrix environment.
Champions learning agility and critical thinking; ability to incorporate new learning.
Contributes to the development of others through coaching and feedback.
People Management (where Applicable)
Requires recruiting, developing and retaining a diverse and capable workforce.
Ensures robust individual training plans and timely completion of required training for direct reports.
Supports talent identification and career development with end-to-end mindset and judgment-based decision making.
Contributes to succession planning, talent assessment and performance/promotion processes with recognition and development of high-talent staff.
Models behaviors and creates an environment where performance and learning are valued.
Seeks opportunities to reward and recognize individuals and teams.
Leads team workload based on portfolio prioritization and regional requirements, addressing implications for resource management.
Supports a culture of innovation and learning from new approaches to clinical development and inclusivity of diverse voices.
Coaches and mentors department personnel and cross-functional members to support development and growth.
Minimum Qualification 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.
Other Information/Additional Preferences
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 with team members and leadership.
Strong problem-solving skills; able to diagnose root causes and take corrective action.
Excellent self-management and organizational skills; able to manage workload and priorities in a multi-team environment.
Strong interpersonal and teambuilding skills; able to develop effective teamwork across diverse styles and provide coaching and feedback.
Strong leadership and influence skills; ability to network across functional components and external partners.
Strong discernment; ability to balance business principles with portfolio perspective.
Flexibility to adapt to frequent change and shifting priorities.
Applied knowledge of project management for cross-functional projects.
Strong digital literacy; proficient in Word, Excel, PowerPoint, and Microsoft Project.
In-depth understanding of the drug discovery and development process.
Scientific background, preferably with direct experience in clinical pharmacology or TA medical.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when applying. If accommodation is required to submit a resume, please complete the accommodation request form at: https://careers.lilly.com/us/en/workplace-accommodation. This is for accommodation requests only and 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 Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $156,000 - $228,800. 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. #WeAreLilly
#J-18808-Ljbffr
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 put people first and strive 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 role partners 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. Advise supervision regarding actual job responsibilities and related duties that may be required for the position. Lead the development of the overall clinical strategy within the relevant Therapeutic Area (TA) in close partnership with the TA-aligned Sr Director.
Lead the strategy for delivery of a platform 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 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 the 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 and 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.
Be a 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 and tools.
Scientific and Therapeutic Area Expertise
Lead the development of the clinical asset strategy for phase 1 using quality decision making principles.
Understand assigned therapeutic area including trial designs, risks and execution challenges and procedures.
Provide consultation to the project team for clinical and regulatory documents such as study protocols, Investigator Brochures (IBs), risk profiles, annual reports, briefing documents, NDAs, safety updates, CSRs, abstracts, publications, and manuscripts.
Stay up to date with current knowledge of relevant disease states/targets, competitors, and industry trends and protocols.
Maintain knowledge of operational requirements to effectively plan exploratory and bio pharmaceutics clinical development studies and submissions, e.g., First Human Dose requirements and operational detail to deliver critical path studies and submissions.
Clinical Project Management
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, 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 the team and to functions, affiliates, and leadership.
Clinical Delivery: Accountable for oversight of clinical trial operations and delivery of clinical project achievements on time and on budget.
Create and manage implementation timelines and clinical trial activities.
Involved in selection process and management of vendors, ensuring day-to-day oversight for operational results of an external network of vendors to ensure on-time and on-budget results.
Serves as the point of contact for the global clinical team to resolve implementation issues, 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.
Communication and Team Management
Influences and works with a quality-focused approach across the clinical team by documenting key decisions, actions and modifications in scope, resources, and timeline; ensure accurate collection and communication of clinical metrics; archive all relevant information at project termination and as appropriate.
Manages key partnerships and interactions with the clinical team, including leadership in governance forums (if applicable).
Effectively and reliably communicates to enable decision-making across the organization.
Leadership
Collaborates effectively with colleagues at all levels; able to work with and deliver through others.
Skilled at working through ambiguity and problem-solving to develop and evaluate molecule-level strategies from lead to legacy.
Successful in persuasion, influence, and negotiation in a matrix environment.
Champions learning agility and critical thinking; ability to incorporate new learning.
Contributes to the development of others through coaching and feedback.
People Management (where Applicable)
Requires recruiting, developing and retaining a diverse and capable workforce.
Ensures robust individual training plans and timely completion of required training for direct reports.
Supports talent identification and career development with end-to-end mindset and judgment-based decision making.
Contributes to succession planning, talent assessment and performance/promotion processes with recognition and development of high-talent staff.
Models behaviors and creates an environment where performance and learning are valued.
Seeks opportunities to reward and recognize individuals and teams.
Leads team workload based on portfolio prioritization and regional requirements, addressing implications for resource management.
Supports a culture of innovation and learning from new approaches to clinical development and inclusivity of diverse voices.
Coaches and mentors department personnel and cross-functional members to support development and growth.
Minimum Qualification 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.
Other Information/Additional Preferences
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 with team members and leadership.
Strong problem-solving skills; able to diagnose root causes and take corrective action.
Excellent self-management and organizational skills; able to manage workload and priorities in a multi-team environment.
Strong interpersonal and teambuilding skills; able to develop effective teamwork across diverse styles and provide coaching and feedback.
Strong leadership and influence skills; ability to network across functional components and external partners.
Strong discernment; ability to balance business principles with portfolio perspective.
Flexibility to adapt to frequent change and shifting priorities.
Applied knowledge of project management for cross-functional projects.
Strong digital literacy; proficient in Word, Excel, PowerPoint, and Microsoft Project.
In-depth understanding of the drug discovery and development process.
Scientific background, preferably with direct experience in clinical pharmacology or TA medical.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when applying. If accommodation is required to submit a resume, please complete the accommodation request form at: https://careers.lilly.com/us/en/workplace-accommodation. This is for accommodation requests only and 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 Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $156,000 - $228,800. 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. #WeAreLilly
#J-18808-Ljbffr