Sr. Director - ExploR&D Regulatory Writing and Capabilities

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work-but it's work worth doing. If you're driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Eli Lilly Cork is made up of a talented diverse team of over 2000 employees across 60 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical Trials and more. Eli Lilly Cork offers a premium workspace across our campus in Little Island, complete with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies and on-site parking. Inhouse People Development services, Educational Assistance, and our 'Live Your BEST Life'

wellbeing initiatives are just some of the holistic benefits that enhance the career experience for our colleagues.

Eli Lilly Cork is committed to diversity, equity and inclusion (DEI). We cater for all dimensions ensuring inclusion of all ethnicities, nationalities, cultural backgrounds, generations, sexuality, visible and invisible disabilities and gender, with four pillars: EnAble, embRACE, LGBTQ+ & Ally and GIN-Gender Inclusion Network. EnAble, our pillar for people with disabilities and those that care for them, partners with the Access Lilly initiative to make our physical and digital environment accessible and inclusive for all. Together they are committed to promoting awareness to create a disability confident culture both at Eli Lilly Cork and beyond.

Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself!

Organization Overview

Lilly Catalyze360 is a comprehensive approach to enabling the early-stage biotech ecosystem by democratizing access to infrastructure, expertise, and resources. Through its interconnected pillars-Lilly Ventures, Lilly Gateway Labs, Lilly ExploR&D, and Lilly TuneLab-Catalyze360 strategically removes barriers that traditionally block bold science from becoming life-changing medicines, providing biotechs with flexible combinations of capital, physical lab space, R&D capabilities, AI/ML tools, and decades of enterprise learning.

Lilly ExploR&D is a team of drug discovery and development experts who partner with biotechs from discovery through clinical proof-of-concept, putting Lilly's industry-leading capabilities behind their missions. We provide flexible support-from strategic consulting to full program execution-making it faster, easier, and more capital-efficient for innovators to transform bold science into life-changing medicines.

Job Summary

The Senior Director will lead the regulatory and medical writing function within ExploR&D, overseeing the preparation and delivery of clinical and regulatory documents and development of IT tools to support the document writing needs of ExploR&D and our partners. The Senior Director will be responsible for business process management, vendor management, systems management, systems implementation, and emerging technology implementation. The Senior Director will provide strategic, tactical, and technical/operational direction, and lead writing deliverables and strategies across the ExploR&D portfolio.

The Senior Director collaborates with cross-functional, multidisciplinary teams, including internal and external stakeholders, to produce high-quality regulatory and scientific documents intended to support regulatory interactions, clinical trial execution, and external partner's strategies.

The Senior Director is responsible for coordinating content across complex documents, ensuring accuracy, compliance, and clarity. These documents may include preclinical, clinical and regulatory documents (such as protocols, investigator's brochures, clinical study reports, briefing documents, regulatory responses, Target Product Profiles, regulatory strategy documents, and Integrated Development Plans), global clinical trial applications (IND/CTA documents), and external scientific publications (such as abstracts, posters, manuscripts, and presentations).

Key Responsibilities

Document Preparation and Management

• Lead cross-functional teams to ensure timely development of writing deliverables
• Manage and track workload; escalate resource capacity issues as needed
• Plan, write, edit, review, and strategically coordinate complex regulatory documents, development strategies, and scientific publications
• Oversee and coordinate quality review and finalization of documents
• Provide expertise on databases and other tools necessary to perform work (such as document management systems)

Consultancy on Behalf of ExploR&D

• Represent ExploR&D in assigned projects, interacting directly with biotech partners
• Strategically build and manage relationships with biotech partners and vendors
• Serve as an expert for ExploR&D portfolio and associated asset development, as it pertains to medical writing activities and related expertise
• Contribute to the identification, prioritization, and assessment of collaboration opportunities
• Maintain and enhance knowledge of regulatory and publication guidelines
• Network with Lilly functions to share best practices

Capability Building and Strategic Leadership

• Build a suite of AI writing capabilities to increase efficiency within ExploR&D, working with internal experts and external vendors
• Identify, evaluate, develop, and implement systems and tools that increase efficiency and streamline document development, such as AI Authoring tools, automation tools and document management systems
• Allocate medical writing resources to support incoming projects
• Support ExploR&D's strategic direction by implementing document standards, workflows, and priorities in support of the portfolio
• Identify and implement improvements in writing processes, standard operating procedures (SOPs), and templates to ensure they are fit for purpose

People Development

• Provide informal coaching to others by sharing technical information, giving guidance, and answering questions
• Support cross-functional coaching, mentoring, and training
• Train, coach, and mentor staff to deepen their medical writing expertise, improve communication skills, and build strong relationships across ExploR&D functions and with external partners (this may be through direct or indirect reporting relationships, as assigned)
• If assigned, recruit, develop, and retain an operationally capable workforce skilled in medical writing and its application in clinical development
• Champion a commitment to quality and safety
• Support a culture that fosters inclusion, innovation, and judgement-based decision making

Minimum Requirements

Education:

• Advanced graduate degree (PharmD, PhD, MD) in a health-related or scientific field

Experience:

• At least 7 years' of experience in the pharmaceutical industry in two or more of the following areas: preclinical development (PK/PD, pharmacology, toxicology), clinical development, CMC, regulatory affairs, regulatory writing.
• Demonstrated mastery of written English with at least 3 years' experience in writing regulatory, clinical trial documents, and/or scientific publications.

Additional Skills and Preferences:

• Experience in clinical trial process and/or regulatory activities.
• Deep understanding of investigational product requirements, especially GCP and GLP regulations.
• Demonstrated leadership in managing document development for various document types/indications.
• Experience in managing external partnerships/vendor relationships.
• Exceptional critical thinking, strategy development, and decision-making skills.
• Demonstrated ability to influence strategies and proven ability to deliver results in a complex or ambiguous environment.
• Demonstrated project management and time management skills.
• Demonstrated strong leadership and team management skills.
• Experience as a direct supervisor or leading cross-functional teams preferred.
• Strong interpersonal skills and the ability to be flexible in varying environments and with multiple customer groups.
• Demonstrated high-level end-user computer skills (such as word processing, working with tables and graphics, spreadsheets, presentation and templates).
• Experience in use, development or implementation of automation tools and software solutions, including AI-driven tools to streamline document creation and development process.
• Ability to work well across cultures and time zones.

Additional Information

• Location: Cork, Ireland; Indianapolis, IN; San Francisco Bay Area, CA; San Diego, CA; Boston/Cambridge, MA; or remote (US) with quarterly travel to Indianapolis. Relocation is not provided.
• Travel up to 10% US and/or OUS
• A writing exercise may be required as part of the candidate evaluation process. Writing samples may be requested.

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 does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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

€93,000 - €136,400

Full-time equivalent employees may also 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 pension plan; vacation benefits; eligibility for healthcare benefits; flexible benefits (if applicable) 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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