14 ott
|
Angelini Pharma
|
Lazio
14 ott
Angelini Pharma
Lazio
ppThe Development Project Leader (DPL) is a key leadership role responsible for managing and driving drug development programs from the start of Preclinical development up to the late Clinical development phase.
The DPL will act as the "asset CEO", leading cross-functional project teams, including experts from RD, regulatory affairs, clinical development, manufacturing, and commercial disciplines, defining the integrated development plan with the team, and ensuring that projects are executed as planned and aligned with the corporate goals.
The ideal candidate will have strong leadership, strategic planning, and communication skills, coupled with deep understanding of the drug development process.
/p h3Main Responsibilities: /h3 ul liDefine project scope, milestones, deliverables, timelines, scenario planning and critical path, leading the overall development strategy including TPP development and project priorities.
/li liLead cross-functional teams acting as a "catalyst for action" to plan, execute, and deliver drug development projects from the start of preclinical development to the late-stage clinical development (Ph III), ensuring alignment with the Governance Committee expectations and with budget, boosting urgency and accountability across the functions, combining domain expertise to develop and articulate strategic alternatives.
/li liAccountable for the project day-by-day decisions and stage-gate readiness, defining project priorities and driving consensus within the team, and for stress-testing functional recommendation to enable effective decision making by the Governance Committees /li liClosely work with the Project Managers and the project teams to proactively identify, assess, and mitigate risks, and develop contingency plans.
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Cross-functional Collaboration /h3 ul liLead cross-functional teams comprising Preclinical, Clinical, Regulatory, Safety, Manufacturing, Quality, Medical, IP, and Commercial functions.
/li liFacilitate effective communication within the team and with senior management, including project review meetings, ensuring alignment across all functions.
/li liRepresent the project team to senior leadership, internal and stakeholders, partners, and advisors.
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Stakeholder Communication /h3 ul liPresent project updates, challenges, and recommendations to senior leadership, and prepare project documentation for the steering committees /li liFoster a collaborative working environment among project teams and stakeholders.
/li liAct as a champion for the project, ensuring clarity and alignment of goals across all levels.
/li /ul h3Education: /h3 ul liAdvanced degree in the Neuroscience field (e.g., PhD, PharmD, or MSc preferred).
/li liMBA or equivalent project management certification (e.g., PMP) is a strong plus.
/li /ul h3Experience: /h3 ul liMinimum of ***** years of experience in pharmaceutical industries, with several years of leading cross-functional teams in global drug development.
/li liStrong experience on clinical-stage assets, preferably CNS therapeutic area.
/li liStrong clinical development experience and understanding of preclinical, manufacturing, and regulatory across global markets (e.g., FDA, EMA, ICH guidelines) are needed.
/li liExperience in budgeting and resource planning.
/li liExperience with governance presentations to senior executives.
/li liExcellent knowledge of the English language /li /ul h3Skills and Competencies: /h3 ul libLeadership: /bProven track record to inspire and lead cross-functional teams in a matrixed organization.
/li libStrategic thinking /b: Ability to maintain a comprehensive overview and strategically connect various elements to ensure alignment with organizational goals /li libTechnical Knowledge: /bSolid understanding of drug development, clinical trial design, regulatory requirements, and product lifecycle management.
/li libCommunication: /bExceptional written and verbal communication skills, with the ability to present complex ideas clearly to diverse audiences.
/li libProject Management: /bStrong organizational skills with a track record of delivering complex projects on time and within budget.
/li libCollaboration: /bAdept at building relationships with internal and external stakeholders, including CROs and regulatory agencies.
/li libAnalytical Thinking: /bStrong problem-solving and decision-making skills, with the ability to analyze complex issues and formulate actionable strategies.
/li libAdaptability: /bComfortable working in a fast-paced, dynamic environment with competing priorities.
/li /ul h3Key Performance Indicators: /h3 ul liAchievement of project milestones within defined timelines and budgets.
/li liSuccessful regulatory submissions and approvals.
/li liEffective cross-functional team collaboration and communication.
/li liRisk identification and mitigation effectiveness.Stakeholder satisfaction with project outcomes and communication.
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📌 Development Project Leader (Lazio)
🏢 Angelini Pharma
📍 Lazio