Regional Medical Director, Specialties LATAM

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.

Regional Medical Lead, Specialties LATAM - Part of the LATAM Hub Medical Lead Team with scope for Mexico and Colombia. This role is heavily involved in influencing strategy and investments across portfolio, Industry & healthcare leadership. They will be accelerating Life Science Vision in key therapeutic areas to ensure Lilly is viewed as a partner of choice across Diabetes and Obesity.

As our Regional Medical Lead, Mexico & Colombia you will drive transformation, strategic planning and thought leader engagement while overseeing the clinical research and overall medical support activities of the function.

This Regional Medical Lead position provides leadership, vision and direction, supervision, coordination, mentoring, career development, and performance management for all activities and individuals that directly report to them within the Mexico & Colombia Medical Affairs and as well as the entire team of MSLs of Colombia.

The Regional Medical Lead, Mexico & Colombia has review responsibilities and approval authority for grants and contracts, label changes, protocols and protocol amendments, informed consent documents, travel authorizations, expense reports, and other documents related to the work of the therapeutic area group within Mexico & Colombia of the therapeutic areas under scope. They will also ensure that all activities of the medical team are in compliance with current local and international regulations, laws, guidance (e.g. FDA, ICH, and CPMP etc.), Good Clinical Practices (GCPs), company standards, Lilly policies and procedures, and the Principles of Medical Research.

Key Responsibilities:

Strategy, Influence and Direction

- Influencing and developing strategy and investment across portfolio, industry and healthcare leadership.
- Responsible for medical transformation in line with therapeutic area needs and organizational model for Mexico & Colombia.
- Builds key capabilities to deliver the portfolio and attracts and retains the best talent.

Career Development and Performance Management of direct reports

- Performance management, career and development plans.
- Maximizes each individual direct report's career potential, maximizing the value to the organization.
- Responsible for presenting the activities, desires, capabilities, and achievements of direct reports to the business area medical management and leaders, HR, and Global Medical Strategy and Development department for talent assessment, performance evaluation, and timely promotion consideration.
- Ensures that CRP/Ss, other direct reports are adequately qualified and trained in the tasks they are required to perform. Includes accountability and compliance for maintaining a current curriculum training map for self and direct reports.

Oversight of clinical planning, budgeting, and execution

- Responsible for affiliate/geographic evaluation and input into clinical planning and contribution to clinical trials and communicates research needs to global Development team, GHO, and PRA teams to ensure Phase 3, 3b, and 4 clinical (and Phase I and II where applicable) programs meet the needs of local/regional customers.
- Responsible for the local/regional clinical planning process for each brand team associated with the business area/therapeutic area, to assure that plans are appropriately aligned with and support brand, affiliate, business area, and company strategies and are completed on time for the annual business planning process.
- Ensures medical team meets or exceeds commitments to Development team(s) for planned and agreed upon clinical research.
- Monitors progress toward implementation of the clinical research plans, and takes appropriate steps with the responsible clinical plans management and CRPs/CRSs if progress is not adequate.
- Monitors progress toward implementation of the other deliverables from the medical team (e.g., publications, field support), and takes appropriate steps with the responsible cross-functional management team(s) to ensure progress.
- Responsible for generating, approving, and ensuring the implementation of local support in clinical research studies to meet the business area's objectives within the resource capabilities.
- Works closely with the business areas management to monitor operational expenses of the group, and take appropriate actions if there are substantial deviations from approved budgets.

Scientific and Technical Expertise

- Role model and functional member of the appropriate research, submission, registration and commercialization support teams.
- Understands and keeps updated with the relevant scientific data.

Scientific data dissemination and exchange

- Oversight of timely dissemination of clinical trial data.
- Oversight of the critical analysis of data and the dissemination of data, including but not limited to manuscripts, abstracts, posters, and slide sets.
- Oversight of the planning of symposia, advisory board meetings, and other meetings with health care professionals.
- Oversight of team's attendance and scientific congress support (e.g., availability to answer questions at exhibits, provide oral and poster presentations, staff medical booth, meet thought leaders, and participate in customer events).

Business/ customer support (pre and post launch)

- Ensures that medical team is trained, and compliant with local, global, and company standards regarding interactions with customers.
- Ensures that there is adequate scientific support for marketing and sales activities.
- Contribute to the development of medical strategies to support brand commercialization activities by working closely with brand teams, global PRA and HO, clinical management or personnel and other cross-functional management during the development of the local business plan.
- Ensures team contributes as scientific and medical experts to activities and deliverables of the PRA organization, in particular giving clinical input and insight to develop payer partnership programs and defend the product value.

Regulatory/ submission responsibilities

- Ensures that clinical data generated for regulatory purposes meets all necessary regulatory standards.
- Provide support for global registrations, labeling and label modifications, and resolution of regulatory issues within the Nordic region.
- Oversight and/or participation in Advisory committee(s).
- Ensures escalation of drug safety and device issues to appropriate Global Patient Safety personnel.

Overall Administrative Responsibilities

- Reviews all major business documents requiring director-level approval. These documents include, but are not limited to research protocols and amendments, research contracts and grants, informed consent documents, label changes, and travel expenses.
- Reviews and approves other types of documents in the absence of responsible medical management or CRP/S.
- Serves as a member of the NE Hub Medical Leadership Team, and as such attends management meetings, and contributes to business area management process and policy development.
- As a member of the MLT, is an active and visible representative of the NE Hub.
- Participates in activities which include, but not limited to overall business area plans and budgets, strategic planning, support of efforts of other components such as staff recruiting, and participation on various business area and corporate committees.
- Ensures that team members respect the highest medical ethical standards of Lilly and of the communities where Lilly does business.

- Responsible for annual business planning for local activities and/or business area, and updates regularly.

- Serves as a representative to groups, committees, or agencies outside the company or the industry.

Position Requirements:

- Scientific background.
- Experience in clinical research (direct or indirect).
- Understanding of the health systems environment.
- Experience in leading, managing, and coaching groups of professionals.
- Excellent communication, interpersonal, and influencing skills.
- Strong organisational skills.
- Ability to travel to support business needs.
- Preferable experience leading medical teams (country, regional or Therapeutic Areas).
- Fluent in English, verbal, and written communication.
- Proven winning mindset, strategic thinking and business acumen.
- Speak up attitude.
- Proven Learning Agility.
- Proven management of complex situations.
- Proven functional or organizational transformational experience.

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