AT1D Medical Program Lead

Job Title: aT1D Medical Program Lead

Location
:
Morristown, NJ

About the Job

Under the oversight of the US General Medicines Program Optimization & Operations Lead, the autoimmune Type 1 Diabetes Medical Program Lead (aT1D MPL) will, in collaboration with the relevant Medical Head, lead the strategic direction and operational execution of the medical brand to establish, implement and execute on strategic objectives, operational and project budget planning, tracking and reviews, as well as oversight of resource allocation to ensure appropriate prioritization of Medical projects across the portfolio dependent on overall business needs.

The MPL will also be responsible to lead the local scientific review process (e.g., local concept/protocol review) and all subsequent applicable aspects of Investigator Sponsored Studies (ISSs) and Externally Sponsored Collaborations (ESCs) to ensure optimum execution in accord with all relevant internal policies/SOPs/guidance and required external regulations and guidelines.

We are an innovative global healthcare company with a focus on immunology that extends to innovation in diabetes and transplant medicine. Across different countries, our talented teams are determined to deliver a best-in-class customer experience using the best of digital, artificial intelligence and personal know-how. With a focus on immunology that extends to innovation in diabetes and transplant medicines, we pursue progress to make a real impact on millions of patients around the world.

Main Responsibilities:

• Facilitate collaboration and effective matrix management with internal and external stakeholders: US and Global Medical Affairs, Monitoring, Legal, Regulatory, Finance, Ethics & Business Integrity, Purchasing, Field Medical, Pharmacovigilance, Clinical Supply, Contract Research Organizations (CROs)/External vendors, Investigational Sites, Investigators of ISSs & ESCs and other relevant functions/organizations to ensure rigor and excellence in all aspects of ISS/ESC processes to ensure timely execution operating within relevant internal Policies, SOPs, Corporate Guidance and relevant external policies/regulations.
• Supportive of Co-leading the Medical Strategy Team (MST) with the Medical Lead(s), ensuring appropriate strategic input, as well as decision making on the tactics and execution plan, ensuring full integration of Regions and Key Functions input, and tracking and implementation on action items and timelines.
• Accountable for US General Medicines Medical ISS/ESC portfolio operational execution including, but not limited to, effective collaborations with Global Medical Operations, timely execution of local concept/protocol reviews (e.g., meeting scheduling, documentation of decision, etc.) contract management, study initiation with subsequent study execution (tracking, monitoring, invoicing, drug supply, deliverables (including publications), etc.). Effectively collaborate with Medical Leads & MSLs on investigator communications.
  
  Conduct routine critical analyses of ongoing studies and deliverables to proactively identify potential risks and ensure sufficient resources, budgets with optimized and realistic timelines. Responsible for study tracking, updates as needed to Medical Program teams and timely remediation of Monitoring observations.
• As prioritized, provide meeting management and facilitation support to the Medical Affairs team to ensure projects and plans move forward.
• Partnering with Medical Lead(s) and full medical brand team in the development and implementation of Medical Plans, Annual Budget Plans and long-range plans to achieve operational excellence and compliance readiness.
• Develop and track medical affairs projects to ensure on-time, in-scope, and on-budget execution; proactively identify potential risks or efficiencies; identify project contingencies and regularly meet with stakeholders (e.g. Clinical Research Organization [CRO], Finance, Publications, Commercial, RWE and Health Economics & Value Access [HEVA] teams) for project updates allowing optimal progress and decision making.
• Oversee and actively manage the medical program budget and spending, rapidly identifying and managing variances, and addressing strategic resource re-allocation/budget challenges to ensure accurate forecasting and expense recognition, proposing solutions and mitigation strategies as necessary to ensure project quality.
• Develop and maintain project timelines and associated budget to ensure robust stretch/realistic targets, project, and action item completion. Lead initiation and completion of the Global Rationale Form (GRF) and Cross Border Engagements as aligned with overall business objectives.
• Maintain Cross Border Status with Canada & other Affiliates to ensure sharing of best practices.
• Lead the purchase-to-pay (P2P) contracting process including but not limited to WBS generation, SOW-processing purchase orders (POs), and change orders for medical projects within the medical plan. Work closely with…