• Lead clinical strategy and execution for ophthalmology trials, including protocol development, study oversight, and data interpretation. • Serve as medical monitor for clinical studies, ensuring patient safety and data integrity. • Author and review clinical documents including protocols, IBs, ICFs, INDs, CSRs, and regulatory submissions. • Collaborate with cross-functional teams (clinical operations, regulatory, biometrics, safety, CMC, commercial) to drive program success. • Engage with external experts, organize advisory boards, and contribute to scientific and medical communications. • Identify and mitigate clinical and programmatic risks. • Support portfolio development and evaluation of new clinical opportunities. • Represent the company in regulatory and scientific forums as needed.

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/Executive Director, Global Regulatory Affairs, Global Regulatory Lead (GRL) role is to develop and implement innovative global regulatory strategies for product(s) in the assigned therapeutic area. The GRL is the accountable decision maker for the development & execution of global regulatory strategies from portfolio entry to end of life cycle to ensure strategies meet global business objectives and regional/local affiliate requirements. The GRL creates and leads the Global Regulatory Team (inclusive of GRA central functions, GRA-CMC, GRA-Devices, and regional regulatory scientists) and is responsible for forming and maintaining a highly effective global regulatory team. The GRL is responsible for the creation and maintenance of the Regulatory Strategy Document (RSD) and ensures local plans, created by the regional regulatory teams, are aligned to the Global Brand Development (GBD)/global program team and business priorities in terms of the program’s value proposition, workflow, product labeling, risk management, and issues management. Accordingly, the GRL is the primary interface with and will represent GRA on GBD/global program team to ensure global input into development plans, provide solutions (created with the regulatory team) to development and regulatory barriers, and reflect and manage risks. The GRL will represent regional regulatory plans to the GBD/global program team and at stakeholder/governance meetings and is responsible to include GRA functional and regional experts as needed to inform development and manage issues. For preclinical and early clinical development programs, the GRL leads the US submissions and agency interactions. All other agency interactions will be the responsibility of the regional regulatory scientists. Primary Responsibilities: Regulatory and Scientific Expertise Develop, Update and Execute the Global Regulatory Strategy - Initiate and Update Regulatory Strategy Document (RSD) - Obtain input from the global regulatory team members to develop a global regulatory strategy which supports product (including delivery device and relevant medical devices) development, registration, and lifecycle maintenance globally. Ensure regulatory strategy is integrated into the development team plan from Candidate Selection to End of Product Lifecyle (including NILEX). Develop and implement innovative approaches and solutions, and drive acceleration strategies. Identify and effectively communicate regulatory risks. - Lead Global Regulatory Team in the development of RSD(s) for assigned programs. Initiate and maintain regulatory strategy documents by leveraging team expertise, as well as scientific, drug/device clinical development and knowledge from health authorities such as regulatory policies, regulatory precedents, trends, and emerging regulatory science. Integrate information from the external environment, product specific regulator advice, and other public information (i.e. Advisory Committees) to develop robust, innovative regulatory strategies and solutions. - Provide input for and attend key regulatory agency meetings, as needed, that could impact the global product strategy or brand. - Enable discussion of the RSD and regulatory issues/challenges at the Regulatory Strategy Forum together with Global Regulatory Team. - Continually expand therapeutic area knowledge. Monitor and assess impact of relevant global regulations, guidance, and current regulatory environment. Monitor upcoming and recent approvals of competitive development programs/plans. - Ensure strategic messaging and content of global regulatory submission documents. Provide regulatory direction in the development of the core data sheet and claims mapping to align commercial objectives in the context of available and expected scientific data, regulatory guidance, and precedent. - Ensures local strategies and solution deliver to the global regulatory strategy and meets BU and brand goals. - Provide timely and effective communication updates to the GBD teams and BU management and other internal stakeholders, as appropriate. Lead Global Regulatory Team - Lead Global Regulatory Team consisting of regional regulatory scientists, GRA-CMC, GRA-Devices, GRA-RD&E, and GRA-Global Labeling and Product Communications. Ensures clear and transparent two-way communication between GBD/global program team and Global Regulatory Team. - Coach and facilitate a feedback culture within the Global Regulatory Team to develop team performance. - Communicate and share key information to enable seamless execution of global regulatory strategy and cross-functional shared learnings. Represent Regulatory on the GBD/Global Program Team - Support development teams in strategic planning, trial design and registration strategies for all in-scope countries for assigned products/programs, bringing in regional, CMC and Device regulatory scientists as needed. - Consistently communicate well defined, successful regulatory strategies throughout the organization. For Preclinical and Early Clinical Development Programs: Lead and develop the US strategy for submission and amendments for IND and IDE - Determine and communicate submission and approval requirements and regulator expectations. - Generate regulatory documents and ensure the regulatory documents contain appropriate data/information based on regulator expectations and are clearly written to articulate Lilly’s scientific position. - Anticipate, resolve, and communicate key technical, operational, and strategic issues that may impact other development functions or the development team. - Propose innovative solutions to regulatory issues to meet the business objectives while maintaining compliance with applicable regulations and internal quality systems. - Own relationship and interaction strategy with US FDA - Execute high quality communications with FDA and internal stakeholders to articulate and ensure understanding of the regulatory strategy and complex issues. - Accountable for communications to the regulator, development teams, GRA, other development functions, Research, and BU leadership. Engage in, influence, and shape external environment initiatives related to portfolio assets - Creates and fosters strategic relationship with key external players to identify and anticipate opportunities for growth. Review corporate communications press releases - Set appropriate direction with Global Marketing and GBD team for development, review, and approval of promotional claims. - Partner with Regulatory Product Communications reviewer to advise GBD team on promotional strategy. - Partner with Regulatory Product Communications reviewer to review and approve press materials and IR communications. Lead/Influence/Partner - Exemplify Team Lilly behaviors: Include, Innovate, Accelerate, and Deliver in internal and external interactions. - Model the innovation, leadership behaviors and regulatory excellence attributes as described in Global Regulatory Affairs white papers. - Participate in forums that share regulatory information across GRA components and other Lilly teams and business partners. - Constructively challenge teams to reach the best solutions to issues. - Serve as a mentor for GRA personnel. - May have direct reports. Minimum Qualification Requirements: - Advanced scientific degree (i.e., PhD, PharmD) and 8+ years Industry-related experience in regulatory affairs and/or drug development experience OR - Bachelor’s degree with 10+ years of industry-related experience in regulatory affairs and/or drug development experience Other Information/Additional Preferences: - Proven experiences and leadership assignments demonstrating bold leadership, exemplary team attributes, effective communications with peers and executive leaders, and effective conflict management skills - Travel expected (10-15%) - Experience in regulatory submissions and regulatory interactions in the US, EU, China and Japan - Previous regulatory or leadership assignments across multiple countries - Industry-related experience in regulatory affairs and/or drug development experience for 10 years - Direct experience in clinical and CMC regulatory sciences - Experience in applicable therapeutic area - Knowledge of Global regulatory procedures and practices and awareness of evolving regulatory reform initiatives - Demonstrated deep knowledge of the integrated drug development process and Lilly’s (or external peer company) regulatory/business strategies - Demonstrated ability to find solutions and alternatives through teamwork, resulting in positive business outcomes - Demonstrated ability to assess and manage risk in a highly regulated environment - Strong written, spoken and presentation communication - Demonstrated negotiation and influence skills - Demonstrated attention to detail 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 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 $169,500 - $248,600 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

Company Overview: It’s not often you get the chance to make a real impact on the lives of others, while expanding your own possibilities. You’ll find that rare opportunity at PharmaEssentia. Join us, and let’s transform lives, together. PharmaEssentia Corporation is a rapidly growing biopharmaceutical innovator. We are leveraging deep expertise and proven scientific principles to deliver effective new biologics for challenging diseases in the areas of hematology and oncology, with one product approved in Europe and a diversifying pipeline. We believe in the potential to improve both health and quality of life for patients with limited options today through the combination of rigorous research and innovative thinking. Founded in 2003 by a team of Taiwanese-American executives and renowned scientists from U.S. biotechnology and pharmaceutical companies, today we are listed on the Taiwan Stock Exchange (6446) and are expanding our global presence with operations in the U.S., Japan, and China, along with a world-class biologics production facility in Taichung. Position Overview: The Director, Field Medical is responsible for providing leadership to the field medical/MSL team across PharmaEssentia’s therapeutic area(s). This position must be based out of Florida or Boston and will be responsible for developing, deploying, and monitoring key performance indicators and encouraging individual professional development goals across the field medical team. This person will also create a robust field medical plan and activate the team to implement. Importantly, this individual will foster and identify opportunities to collaborate across functions and to support critical projects such as engagement with clinical trial sites and clinical trial investigators. Job Responsibilities: - Provide leadership to the field medical team - develop and track team goals and ensure technical/skills training. - Develop, deploy, and monitor key performance indicators - deliver and communicate reports to senior leadership regularly and as needed. - Uphold and ensure compliance standards across the field medical team - support adherence to relevant regulatory requirements, required trainings, and company Standard Operating Procedures. - Effectively demonstrate and communicate the value of Field Medical across the PharmaEssentia global organization, and to senior leadership. - Create a robust field medical plan across US national, regional, and community healthcare practitioners, including academic institutions and community centers. Activate team to develop and execute individual territory plans annually and revisited quarterly or as needed. - Support development and execution of stakeholder engagement strategy to ensure timely and accurate scientific communication. - Drive scientific exchange and ensure the field medical team has the resources necessary to support robust communication- both proactive and reactive. - Develop and drive reactive and proactive field medical initiatives; collaborate to oversee creation and approval of field medical resources supporting these initiatives. - Drive insight generation to ensure actionable insights are generated, captured, and communicated across the organization. - Identify opportunities to collaborate across Clinical Development and Medical Affairs and to support critical projects such as engagement with clinical trial sites and investigators and data communication, as appropriate - Encourage and identify opportunities for professional development for team Including developing and deploying individual development plans. - Create platforms to share best practices across geographies and with other affiliates - Support compliant and effective cross-functional collaboration as needed and appropriate. Requirements & Experience - PhD, PharmD, or MD/DO required - 7+ years of relevant field medical experience in hematology and/or oncology, including at least 2 years in a management role - Excellent field team leadership, management, and coaching skills - Strong track record of driving team performance to meet both qualitative and quantitative goals and KPIs - Demonstrated experience developing and executing field medical activities including proactive and reactive initiatives - Knowledge of the community oncology landscape - Broad experience in collaborating with external KOL and HCP partners and in managing multiple tasks and complex projects - Ability to articulate complex scientific and medical information in understandable business terms - Travel required - 50% Preferred Experience - Launch experience The expected salary range for this position is $235,000-265,000. Actual salary pay will be based on multiple factors, including geographic location, experience, qualifications, and other job-related factors permitted by law. Benefits of working with our team: PharmaEssentia USA strives every day to improve the lives of patients as well as our employees. As a valued member of PharmaEssentia USA, you will enjoy the following benefits: - Comprehensive medical coverage - Dental and vision coverage - Generous paid time-off - 401(k) retirement plan with competitive company match - Medical & Dependent Care Flexible Spending Account - Up to $150 monthly cell phone reimbursement - Employee Assistance Program At PharmaEssentia USA, we are committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants without regard to race, color, religion, sex, pregnancy (including childbirth and related medical conditions), national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information (including characteristics and testing), military and veteran status, and any other characteristic protected by applicable law. PharmaEssentia USA believes that diversity and inclusion among our team are critical to our success as a global company, and we seek to recruit, develop and retain the most talented people from a diverse candidate pool. PharmaEssentia does not accept unsolicited agency resumes. Staffing agencies should not send resumes to our HR team or to any PharmaEssentia employees. PharmaEssentia is not responsible for any fees related to unsolicited resumes from staffing agencies. At PharmaEssentia, our goal is to treat as many people with cancer as possible. That means challenging the status quo with better science that leads to better lives. By joining our team, you will not only expand your own possibilities, but you will contribute to expanding options for people with cancer. https://us.pharmaessentia.com/careers/

JLL empowers you to shape a brighter way. Our people at JLL are shaping the future of real estate for a better world by combining world class services, advisory and technology for our clients. We are committed to hiring the best, most talented people and empowering them to thrive, grow meaningful careers and to find a place where they belong. Whether you’ve got deep experience in commercial real estate, skilled trades or technology, or you’re looking to apply your relevant experience to a new industry, join our team as we help shape a brighter way forward. To be completed once JD is updated. This position does not provide visa sponsorship. Candidates must be authorized to work in the United States without sponsorship. Estimated compensation for this position: 200,000.00 – 325,000.00 USD per year This range is an estimate and actual compensation may differ. Final compensation packages are determined by various considerations including but not limited to candidate qualifications, location, market conditions, and internal considerations. Location: Remote –Knoxville, TN If this job description resonates with you, we encourage you to apply, even if you don’t meet all the requirements. We’re interested in getting to know you and what you bring to the table! Personalized benefits that support personal well-being and growth: JLL recognizes the impact that the workplace can have on your wellness, so we offer a supportive culture and comprehensive benefits package that prioritizes mental, physical and emotional health. Some of these benefits may include: - 401(k) plan with matching company contributions - Comprehensive Medical, Dental & Vision Care - Paid parental leave at 100% of salary - Paid Time Off and Company Holidays - Early access to earned wages through Daily Pay At JLL, we harness the power of artificial intelligence (AI) to efficiently accelerate meaningful connections between candidates and opportunities. Using AI capabilities, we analyze your application for relevant skills, experiences, and qualifications to generate valuable insights about how your unique profile aligns with the specific requirements of the role you're pursuing. JLL Privacy Notice Jones Lang LaSalle (JLL), together with its subsidiaries and affiliates, is a leading global provider of real estate and investment management services. We take our responsibility to protect the personal information provided to us seriously. Generally the personal information we collect from you are for the purposes of processing in connection with JLL’s recruitment process. We endeavour to keep your personal information secure with appropriate level of security and keep for as long as we need it for legitimate business or legal reasons. We will then delete it safely and securely. For more information about how JLL processes your personal data, please view our Candidate Privacy Statement. For additional details please see our career site pages for each country. For candidates in the United States, please see a full copy of our Equal Employment Opportunity policy here. Jones Lang LaSalle (“JLL”) is an Equal Opportunity Employer and is committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation because of a disability for any part of the employment process – including the online application and/or overall selection process – you may email us at HRSCLeaves@jll.com. This email is only to request an accommodation. Please direct any other general recruiting inquiries to our Contact Us page > I want to work for JLL. Pursuant to the Arizona Civil Rights Act, criminal convictions are not an absolute bar to employment. Pursuant to Illinois Law, applicants are not obligated to disclose sealed or expunged records of conviction or arrest. Pursuant to Columbia, SC ordinance, this position is subject to a background check for any convictions directly related to its duties and responsibilities. Only job-related convictions will be considered and will not automatically disqualify the candidate. California Residents only If you are a California resident as defined in the California Consumer Privacy Act (CCPA) please view our Supplemental Privacy Statement which describes your rights and disclosures about your personal information. If you are viewing this on a mobile device you may want to view the CCPA version on a larger device. Pursuant to the Los Angeles Fair Chance Initiative for Hiring Ordinance, JLL will consider for employment all qualified Applicants, including those with Criminal Histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance. Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records. Accepting applications on an ongoing basis until candidate identified.