Director Medical Affairs Operations

Egetis Therapeutics AB

7d•Hybrid

About The Position

The Director of Medical Affairs Operations (US) is a newly created position reporting to the Head of Medical Affairs, North America. This person will be responsible, in collaboration with the Head of Medical Affairs, NA, for building and executing the operational model and processes necessary to support our growing Medical Affairs function as we prepare for our first launch in the US. This individual will join a small, nimble and energetic organization that requires excellent communication, organization and collaboration skills. This role requires a strategic thinker who demonstrates excellence in program leadership, operational design, and disciplined execution. This role will serve as the operational backbone of US Medical Affairs and key integrator across field, office-based and global teams. This role will function as the primary operational point of contact for the US Medical field team and cross-functional partners regarding Medical Affairs processes, systems, governance, metrics, and execution support.

Requirements

Bachelor’s degree required; MBA in Organizational Performance or Project Management certification a plus
7+years of experience in a Medical Affairs Operations role; rare disease experience preferred.
Advanced understanding of drug development and Medical Affairs/Medical Affairs Operations, including compliance, legal and financial requirements
Experience working in a small company or a start-up environment, comfortable operating with limited infrastructure.
Ability to travel up to 20% of the time
Exceptional project management, budgeting and vendor management skills.
Demonstrated ability to track performance against the strategic Medical Affairs plan and budget, proactively identify risks, and recommend mitigation strategies, and apply relevant metrics and communication tools
Highly collaborative with ability to interact professionally across all levels of the organization
Highly organized, with keen attention to detail, strategic yet highly proficient tactically
Possess a mindset of continuous improvement focused on maximizing team efficiency and effectiveness, including demonstrated strength to critically evaluate processes and the ability to communicate opportunities to improve team efficiency.
Excellent written and verbal communication skills
Advanced proficiency with Microsoft Excel and PowerPoint, and Smartsheets

Responsibilities

Drive development and maintenance of the US strategic medical affairs plan.
Ensure effective delivery of US Medical Affairs projects and business operations activities. Evaluate tactical execution against plan, identify risks and propose mitigation strategies as appropriate.
Develop a budget consistent with the strategic medical affairs plan. Monitor adherence to the budget.
Apply experience collaborating with legal, compliance and finance tofacilitatecontract and purchase order implementation. Track invoices against SOWs and budget. Conduct vendor onboarding for vendors supporting US Medical Affairs activities.
Own development and implementation of effective communication tools to clearly communicate progress against performance targets.
Drive continuous improvement in strategic planning and operational performance.
Ensure development, implementation, and maintenance of US Medical Affairs SOPs, working instructions, and governance frameworks, ensuring compliance with internal policies and regulatory requirements.
Oversee governance and operational management of medical grants, sponsorships and Investigator initiated studies ensuring compliance, documentation integrity and financial tracking.
Provide internal operational support to the Egetis Medical Affairs Lead of the ongoing Expanded Access Program,
Work with internal colleagues and vendor partners to support Congress Planning and Publications management.
Collaborate with Head of Medical Affairs and vendors on planning and execution of Advisory Boards/Working Group meetings, including execution of participant contracts and payments, and legal review/approval of meeting content.
Execute agreements and activities required by specific professional organizations with whom US Medical Affairs engages
Drive the MLR review and approval process for US-focused materials, including uploading documents, ensuring appropriate annotation and linking of supporting references, appropriate reviewer assignment, resolution of comments, and final approvals. This includes coordination with vendors who may conduct elements of the process for some materials. Significant experience with Veeva Promomats preferred.
May be asked to support key initiatives and team meetings for the President, North America, and Heads of Commercial and Access and Pricing
As relevant oversee the process for Investigator Initiated Studies and other external research collaborations and grants/sponsorships. Develop and maintain a database to archive agreements, contracts and payments.
Synthesize insights from MSLs, advisory boards, congresses, EAP, and Medical Information to inform US and Global Medical strategy and ensure structured reporting to leadership.
Act as operational lead for Field Medical, supporting materials, training, systems, compliance, vendor coordination, and tracking field execution against the US tactical plan.
Foster cross-functional engagement. Build an effective network within Medical Affairs, with cross-functional partners in the US and EU and with external partners.
Ensure strategic alignment across US Medical Affairs, the US cross-functional team and global cross-functional partners, a sappropriate to accomplish corporate goals.
Collaborate with US Medical Affairs colleagues to monitor tactical plan execution, and promote accurate metrics reporting