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 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 and 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 interpersonal skills applied to matrix organization, effective international collaboration and external alliance partnering skills.

Why Choose Us?

• 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.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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