DEVELOPMENT PROJECT LEADER

The 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 R&D, 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.

Main Responsibilities:

• Define project scope, milestones, deliverables, timelines, scenario planning and critical path, leading the overall development strategy including TPP development and project priorities.
• Lead 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.
• Accountable 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
• Closely work with the Project Managers and the project teams to proactively identify, assess, and mitigate risks, and develop contingency plans.

2. Cross-functional Collaboration

• Lead cross-functional teams comprising Preclinical, Clinical, Regulatory, Safety, Manufacturing, Quality, Medical, IP, and Commercial functions.
• Facilitate effective communication within the team and with senior management, including project review meetings, ensuring alignment across all functions.
• Represent the project team to senior leadership, internal and stakeholders, partners, and advisors.

3. Stakeholder Communication

• Present project updates, challenges, and recommendations to senior leadership, and prepare project documentation for the steering committees
• Foster a collaborative working environment among project teams and stakeholders.
• Act as a champion for the project, ensuring clarity and alignment of goals across all levels.

Education:

• Advanced degree in the Neuroscience field (e.g., PhD, PharmD, or MSc preferred).
• MBA or equivalent project management certification (e.g., PMP) is a strong plus.

Experience:

• Minimum of 10-15 years of experience in pharmaceutical industries, with several years of leading cross-functional teams in global drug development.
• Strong experience on clinical-stage assets, preferably CNS therapeutic area.
• Strong clinical development experience and understanding of preclinical, manufacturing, and regulatory across global markets (e.g., FDA, EMA, ICH guidelines) are needed.
• Experience in budgeting and resource planning.
• Experience with governance presentations to senior executives.
• Excellent knowledge of the English language

Skills and Competencies:

• Leadership: Proven track record to inspire and lead cross-functional teams in a matrixed organization.
• Strategic thinking : Ability to maintain a comprehensive overview and strategically connect various elements to ensure alignment with organizational goals
• Technical Knowledge: Solid understanding of drug development, clinical trial design, regulatory requirements, and product lifecycle management.
• Communication: Exceptional written and verbal communication skills, with the ability to present complex ideas clearly to diverse audiences.
• Project Management: Strong organizational skills with a track record of delivering complex projects on time and within budget.
• Collaboration: Adept at building relationships with internal and external stakeholders, including CROs and regulatory agencies.
• Analytical Thinking: Strong problem-solving and decision-making skills, with the ability to analyze complex issues and formulate actionable strategies.
• Adaptability: Comfortable working in a fast-paced, dynamic environment with competing priorities.

Key Performance Indicators:

• Achievement of project milestones within defined timelines and budgets.
• Successful regulatory submissions and approvals.
• Effective cross-functional team collaboration and communication.
• Risk identification and mitigation effectiveness.Stakeholder satisfaction with project outcomes and communication.