US Transplant Medical Program Lead (MPL) (Hiring Immediately)

Job Title : US Transplant Medical Program Lead (MPL)

Grade : L3

Hiring manager : Peg Bollella

Location : Morristown, NJ

About the Job

Under the oversight of the North America (NA) General Medicines US Program Optimization & Operations Lead, the US Transplant Medical Program Lead (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, NA Corporate Integrity Agreement Monitors, 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 & Medical Science Liaisons 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 Board and timely remediation of CIA 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 Strategic 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 HCP / Patient Engagement team to ensure timely contract processing to maintain overall project timelines.

Drive timely execution of local and global reporting requirements in alignment with both internal and external regulations.

Responsible to work directly with leadership to remediate relevant internal and external audit observations.

Evolve Process Simplification & Ways of Working to maximize output & minimize risk.

Internal and External Stakeholder Management - KOL engagement oversight across all functions in NA (e.g., ad boards, congress interactions, disease state presentations, publications, etc.).

Performing other duties as assigned.

About You

Skills and Competencies Required :

Strategic thinking, proactive, self-starter able to manage work priorities and follow tasks through completion with a high sense of urgency

Proven leadership, capacity to oversee and coordinate several activities and stakeholders including external partners, if relevant

Expertise in managing large and complex projects and in managing cross functional teams.

Knowledge of drug development and regulatory processes, with emphasis on establishment and execution of Medical Affairs initiatives, and thorough knowledge of external landscape and competitor field.

Ability to network and communicate across diverse functions, and to work in a matrix organization.

Strong business acumen, critical thinking, along with technical and problem-solving skills ability to challenge the status quo; ability to anticipate risks and orchestrate plans to resolve issues and mitigate risks

Strong ability to communicate and present complex issues in a simple and concise manner to project teams as well as leadership teams

Quick learner, goal oriented and results driven with excellent problem-solving skills and ability to escalate issues appropriately

Ability to propose strategies for asset optimization (Life Cycle Management).

Developing and tracking budgets across multiple projects

Thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient

Demonstrate managerial courage to make and stand by difficult decisions

Influencing skills to motivate team members for best performance and outcomes.

Excellent communication skills written and oral.

Excellent proficiency in Microsoft PowerPoint and Excel

Proficient with Project Management best practices and tools including MS Project

Fluent in English

Education and Background

Degree in a scientific discipline (e.g. BS, MS, PhD, PharmD, etc.) or related degree with substantial project management and / or project leadership experience preferred. Business qualifications such as MBA or professional project management qualification such as PMP would be of additional benefit.

5+ years of experience in expanding roles in drug development or related field, including experience and understanding of the current pharmaceutical environment, including sound understanding of the therapeutic area preferred

Professional experience managing complex projects, demonstrating effective communication and leadership, ability to successfully bridge between different fields of expertise, and managing program risks and challenges (including scenario and contingency planning) preferred.

Knowledge of project planning tools, budget structure and management science.

Transversal communication and networking demonstrated. Managerial and inte