US Transplant Medical Program Lead (MPL)

Sanofi; Morristown (NJ); On-site; USD 100,000 - 130,000; Full time

Benefits offered by this job

High-quality healthcare

Wellness programs

Parental leave

Job summary

A leading pharmaceutical company in Morristown, NJ is seeking an experienced professional to manage its medical affairs projects. This role entails facilitating collaboration among various stakeholders, overseeing project execution, and ensuring compliance with regulatory requirements. The ideal candidate will have over 5 years of experience in drug development, proven leadership skills, and expertise in managing complex projects. Competitive compensation and comprehensive benefits are offered.

Qualifications

• 5+ years of experience in drug development or related field.
• Professional experience managing complex projects.
• Fluent in English.

Responsibilities

• Facilitate collaboration with internal and external stakeholders.
• Accountable for medical ISS/ESC portfolio operational execution.
• Drive timely execution of local and global reporting requirements.

Skills

Strategic thinking

Leadership

Project management

Communication skills

Problem-solving

Education

Degree in a scientific discipline

MBA or project management qualification (PMP)

Tools

Microsoft PowerPoint

Microsoft Excel

MS Project

Job description

**Grade:** L3**Hiring manager:** Peg Bollella**Location:** Morristown, NJ* 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.* 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* 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 interpersonal skills applied to matrix organization, effective international collaboration and external alliance partnering skills.* Bring the miracles of science to life alongside a supportive, future-focused team.* Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.* Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.* Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.