Associate Director - Clinical Delivery Capabilities - Relationship Manager

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.

The purpose of the Associate Director/Director Relationship Manager role is to provide operational leadership to support exploratory and biopharmaceutics clinical development. The role collaborates across the organization including with functional and organizational partner groups to deliver knowledge, expertise, standard templates, and technology to identify various clinical development scenarios and provide functional expertise to ensure successes of portfolio delivery. This role continually provides expertise in vendor management process and methodologies of EMP whilst looking for internal and external advancements and improvements. This includes driving robust, strategic discussions with clinical and functional counterparts and identification of vendors/TPOs to recommend and incorporate different scenario strategies for efficiencies, innovation and speed.

Key areas of responsibility of the role include:

a) Vendor Relationship management

b) Leading activities supporting study development and execution of portfolio

c) Cross-functional systems and processes including metrics and reporting to support governance activities

In addition to knowledge of ICH and quality guidelines needed for successful delivery of the portfolio and clinical trials, the Associate Director/Director Relationship Manager possesses the business acumen, process knowledge, and influence required to lead in process and quality improvement efforts. The Associate Director/Director, Relationship manager will seek knowledge from internal and external sources and use this information to drive strategic discussions with clinical and functional counterparts make recommendations to gain efficiencies and speed to shape development plans and continuous improvement opportunities.

Responsibilities:

Vendor Relationship Management

Collaborate with CDC team & cross-functional stakeholders to develop effective sourcing strategies for successful delivery of the portfolio

Lead and execute sourcing strategies, liaising with both internal and external partners.

Oversee relationship-level implementation of the sourcing strategy.

Build and manage relationships with third parties and alliance partners to deliver successful outcomes.

Provide leadership on functional/technical assessment of new vendors (and renewals) and provide input into operational plans.

Evaluate new/incoming projects with other functional leads, offering development options that meet project/portfolio requirements, including risk management.

Anticipate and resolve communication sourcing needs and collaborate with sourcing contacts and leadership to evaluate future providers.

Drive excellence in standards across all functions to improve output and influence at all levels.

Provide relationship level oversight and support the implementation of the sourcing strategy.

Deep understanding of the portfolio managed by each of the TPOs, their strengths and capabilities to deliver successful outcomes.

Consult on functional, cross-functional, corporate, and cross-geography initiatives.

Represent functional best practices and requirements for successful implementation of processes, tools, technology, and roles and responsibilities.

Lead evaluation/implementation of new capabilities, including organizational change management strategies.

Partner with cross-functional, multidisciplinary teams to influence planning and strategies

Provide coaching, mentoring and consultation to others by sharing information, giving guidance, and answering questions across therapeutic areas, compounds, geographies.

Study Development and Execution Support:

Establish networks with other key support areas to support efficiently and effectively exploratory and biopharmaceutics clinical studies. The team will support study development by owning updates to corporate systems and processes e.g. eTMF and the contracting elements for a study.

Provide leadership in developing the right sourcing strategy for EMP, business interactions with TPO partners; helping to execute the exploratory and biopharmaceutics clinical development portfolio. Lead and partner in the issue escalation and relationship management processes, vendor, and clinical research unit assessments as appropriate.

Maintain awareness of regulatory issues and trends relevant to assigned portfolio

Cross-Functional Systems and Processes:

Provide leadership in business processes supporting early phase development.

Established expertise on key business systems that support exploratory and biopharmaceutics clinical development.

Review of established procedures across multiple subject areas, dependent on the change agendas to be evaluated and prioritized. Contribute to the overall strategic direction of cross-functional systems and process alongside our vendors

Draw on deep exploratory and biopharmaceutics clinical development knowledge and process expertise to review processes and when necessary, sponsor improvement initiatives to increase business efficiency and value both internally and with our strategic external partners

Ensure cross-functional process alignment internally and externally where appropriate.

Act as a key resource to internal governance committees regarding processes utilized in the exploratory and biopharmaceutics clinical development.

Ensure optimal network with the Quality, Clinical Information and Process Automation, and L&D organizations

People Management and Employee Development:

Attract, retain, and develop a diverse workforce.

Model behavior's 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.

Provide supportive environment for staff to explore innovative solutions to business problems and implement

strategic and tactical decisions.

Contribute to succession planning, talent assessment and performance/promotion processes. Ensure high talent staff are appropriately rewarded and developed.

Coach and mentor department personnel, and as needed, cross-functional members, to affect development and growth of all team members.

Basic Requirements:

Bachelor’s degree in a science related field from an accredited college or university; or equivalent

Qualifications/experience (3-years’ experience in the pharmaceutical industry with direct experience of Managing clinical studies, ideally in exploratory and biopharmaceutics clinical development (5+ year preferred alongside direct vendor management)).

Additional Skills:

In-depth knowledge of ICH and quality guidelines for successful portfolio and clinical trial delivery.

Strong business acumen, process knowledge, and influence to lead process and quality improvement efforts.

Demonstrated project management and time management skills.

Demonstrated ability to work effectively cross-culturally and in a virtual work environment.

Demonstrated ability to influence both internal and external environments appropriately and forge strong working relationships.

Strong organizational and interpersonal skills and the ability to be flexible in varying environments and with multiple customer groups.

Strong verbal reasoning, attention to detail, critical thinking, problem solving, and analytical abilities.

Proven experience of coaching and mentoring others.

Ability to travel (up to 10% expected – varies dependent on responsibilities)

Proven experience in vendor management and relationship building.

Direct supervisory experience

Deep expertise in one or more clinical research functions (clinical operations, sourcing, data sciences)

Exploratory and biopharmaceutics clinical development, quality and Six Sigma experience preferred.

Demonstrated high-level, end-user computer skills (e.g., word processing, tables and graphics, spreadsheets, presentations, and templates).

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.

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