Director - Global GI Portfolio and Pipeline

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.

Organization Overview:

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

Purpose:

Lilly depends on successful launches for multiple products across many therapeutic areas and geographies. Efficient launch preparation strategies and processes are critically important. The external environment is constantly evolving and continues to grow in complexity. Access to medicines and price/reimbursement has an increasingly higher level of importance and our health care professional (HCP} customers are demanding more real-world, evidence-based therapies and solutions. We must introduce ourselves to those and other customers in a way that establishes significant relationships, helps them understand the context and therapeutic value of our medicines and services, and prepares for their questions.

A successful launch requires competence in several specialized areas, including unlocking payer access and having effective commercialization plans in diverse health care ecosystems. The Director GI Portfolio and Pipeline will provide strong leadership and impact for the team on current GI marketed product and contribute work to the pipeline assets to deliver successful launches through individual contributions and through influence on the compound team that reports through MDU or Medical Affairs.

The Director GI Portfolio and Pipeline will facilitate planning and execution in conjunction with the commercial and clinical teams, which includes specific working groups (Marketing, Payer and Reimbursement Access, Medical Education, Medical Information, Advocacy and Professional Relations, Real World Evidence, Central Medical Capabilities and Scientific Data Disclosure}. Director GI Portfolio and Pipeline collaborates across geographies with Medical Affairs teams in the US, ACE (Australia, Canada, and Europe}, Japan, and the Emerging Markets, shaping the content through an ongoing dialogue with external thought leaders.

In close partnership with GPORWE and MDU functions, the Director GI Portfolio and Pipeline will participate in the planning and execution of coordinated evidence generation. Close collaboration will also be required with the Global Brand Development (GBD} Medical Director; Regional Therapeutic Area Medical Leaders; Affiliate Medical Directors, physicians, and scientists; and the Brand's commercialization and PRA leaders. The Director GI Portfolio and Pipeline will actively consult and contribute to the development of Phase 3 and NILEX studies and is accountable for the development and implementation of Global Phase 3B (not for registration} and Global Phase 4 studies.

The successful Medical Launch Indication will identify key themes for the successful launch of a new product and will articulate those themes across working groups and geographies, while also identifying and collaborating with the key external thought leaders who will influence the acceptance of the new product in the clinical community.

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

Accountable for execution elements of branded product's annual medical plan under the mentorship of the GMA hub leader and GI TA lead as well as accountable for Global Medical Affairs launch and strategy, including responsibility for ensuring that the needs and education of payers, prescribers, and the other non-regulatory team members who influence patients' treatment access or benefits are met. Key activities include

• Development and execution of thought leader/key doer strategy
• Planning, development, and execution of Phase 3 and 3B through Phase 4 clinical research, RWE trials, ensuring the clinical program includes a robust comprehensive evidence package.
• Applying Next Generation Development into launch planning and execution
• Medical and disease state education, publications, medical information, and medical affairs advisory boards

Collaborate with GBD and affiliate/regional brand teams for launch preparation and serve as the primary medical leader for commercial-related activities, providing input for the following brand development activities.

• Foundational insights for patients, providers, and payers (patient segmentation, patient journey, environmental evolution, etc.)
• Core brand development (global positioning, global brand planning, etc.)
• Commercialization activities and program development (customer council, brand planning, etc.)

Focus on product launches in the US and EU, and (as appropriate) Japan, Canada, Australia, China, and other key IBU countries. Serve as a resource and advocate for affiliates and regional medical affairs teams. Relay their needs back to the global team (including alliances). Be aware of and ensure that all medical affairs activities are in compliance with Good Clinical Practices (GCPs), company standards, Lilly policies and procedures, company integrity agreements as applicable, and the Principles of Medical Research, and that activities are aligned with the medical vision.

Launch Readiness Strategy

• Accountable for launch readiness capability assessment for Global Medical Affairs in collaboration with global brand development, project management, and commercialization teams; responsible for preparing global and affiliate medical/marketing teams with a medical launch readiness plan including recommended capacity, tactics, and OPEX to support a successful launch
• Contribute to the development of overall product launch strategy and medical affairs strategies to support brand commercialization activities by working closely with the global brand, PRA, Advocacy and Professional Relations teams, appropriate affiliate or region medical/marketing/PRA team, clinical plans personnel, and other cross-functional management
• Accountable to lead and strive to completion Global Medical Affairs launch readiness activities including education strategy and tactics, key leader mapping/engagement, internal scientific and molecule training, medical FAQ development, Med Info/Medical Liaison training, and other key activities required for the successful launch of a product
• Contribute to the business unit and global alignment of clinical strategy and clinical plans
• Understand and keep updated with the preclinical and clinical data relevant to the molecule
• Consult in the development and maintenance of a Draft Launch Label and Value Proposition that addresses key customer needs (patient, provider, and payer), the product lifecycle plan, clinical strategies, development plans and benefit-risk assessments for patients, commercial potential, launch strategy, and implications to global core and key labels in major geographies
• Anticipate and actively address customer (payer, patient, and HCP) questions in a timely fashion by leading data analyses; analyses of customer questions; and new clinical, health outcomes, or Real World Evidence research efforts

• Responsible for identifying, understanding, and engaging key leadership
• Accountable for development and implementation of the key leader engagement strategy and plan; will seek consultation and collaboration from Global Marketing team, GBD Medical Director, Global PRA, the Thought Leader Capability Office, GPROWE and Regional/Affiliate Medical Affairs teams
• As appropriate, identify and collaborate with external scientific experts and leaders with vision who share our mission and a curiosity about our work
• Interact with Advocacy and Professional Relations and maintain relationships with advocacy groups and professional societies

• Understand and share broadly the scientific information needs of all customers (payers, patients, health care providers) and serve as a key consultant to the GBD Leader and GBD Medical Director in registration program design, endpoints, indication statement/claims, and label
• Support the implementation of NGO (Project Phases 2 and 3)
• Accountable to plan and lead all aspects of execution of non-registration studies vital or relevant for launch and/or improved patient outcomes; this work may be RCTs, observational studies, pre-clinical works, or post-hoc analyses of existing databases (including RWE); examples of topics include delineation of target patient, other disease state work, understanding impact or mechanism of clinical differentiation, studies on other treatments, comparative effectiveness, value/cost assessments, etc.; GBD Medical Director must be consulted on these activities

• Regularly consult on the strategic planning for the brand and on lifecycle planning
• Visible and available to affiliates and regions as a consultant; leverage corporate center-based resources
• Accountable and responsible for execution of Global Medical Affairs advisory boards, speaker programs, GBD-and US- owned scientific symposia, professional meetings, and conferences
• In collaboration with affiliate medical leadership, coordinate the GBD relationships with ML groups globally through internal molecule training and onboarding as well as understanding key customer insights from the field
• Support business-to-business and business-to-government activities as a medical expert
• Review, offer scientific and/or medical comments, and approve promotional materials and tactics
• Support the design of customer research as a medical expert
• Support training of medical personnel, including geographic/affiliate CRP/Ss, medical and outcome liaisons, and health outcomes personnel

• Responsible for the overall scientific disclosure plan (Senior Medical Director/GBD to retain authority/sign off on plan)
• Ensure knowledge of and compliance with global policies and procedures, and compliance guidelines with respect to data dissemination and interactions with external HCPs
• Understand and address the unsolicited scientific information needs of external HCPs according to the guidelines above
• Support medical information associates in preparation and review of medical letters and other medical information materials
• Prepare and/or review scientific information in response to customer questions or media requests
• Support data analysis and the development of slide sets and publications (abstracts, posters, manuscripts)

• Critically read the relevant medical literature, know the status and data from competitive products, and maintain knowledge of medical and other scientific developments relevant to the product
• Represent Lilly and its Medical team as a credible colleague and scientific expert in the external and internal scientific community; work closely with development team to ensure the implication of clinical trial results and conclusions are understood and the external opinions in these conclusions are included
• Be aware of current trends and projections for clinical practice and access
• Explore and take advantage of opportunities for extramural scientific experiences and attend relevant scientific symposia

• May provide direct supervision to assigned clinical research physicians, clinical research scientists, and an administrative assistant
• Serve as leader for the cross-functional or virtual medical launch team supporting medical personnel from MDU and Global US Medical Affairs
• Support the management team, including the GBD leader, in preparation and administration of the business unit development budget, especially as it pertains to Phase 3B or Phase 4 trials
• Actively set and meet individual professional development goals and contribute to the development of others by being an active source of mentoring and feedback
• Actively engage in recruitment, diversity, and retention efforts
• Join in committees, Six Sigma initiatives, and task forces as requested by management
• At all times must be adequately qualified and trained in the tasks required to perform, including accountability and compliance for maintaining a current curriculum training map for self
• Model the leadership behaviors of and be an ambassador for the Lilly Brand

Minimum Qualification Requirements:

• PharmD or PhD degree with board eligibility or certification (preferred), or equivalent stature if non-US trained
• A minimum of 3 years Gastroenterology experience including at least one year in pharmaceutical industry required

Additional Skills/Preferences:

• Knowledge of medical affairs, and substantial experience preferred with the GI brand
• Knowledge of drug development process
• Experience desirable in health policy, health outcomes, statistics, payers, and/or healthcare organizations
• Excellent track record in personal engagement with thought leaders
• Strong ethics, patient-focus, and ability to earn credibility and trust
• Fluent in English, both written and verbal communications
• Interpersonal, organizational, and negotiation skills
• Excellent teamwork skills, including working with those from different backgrounds
• The role will require extensive internal networking, therefore a track record of success within Lilly is preferred

Other Information:

• This role is Indianapolis based however hybrid/remote will be considered.
• Willing to engage in domestic and international travel to the degree appropriate to support the business of the team (which at times will be extensive)

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

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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