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Program Lead
Il y a 3 mois
**Job Reference**
- PL2023**Contract**
- Full time**Location**
- Marseille, France (hybrid working)Innate Pharma S.A. is a global, clinical-stage oncology-focused biotech company dedicated to improving treatment and clinical outcomes for patients through therapeutic antibodies that harness the immune system to fight cancer.
**Overall Objectives & Purpose of the role**:
- The Program Lead is responsible for leading the definition and delivery of an integrated* asset strategy throughout the lifecycle maximizing the value of the asset/program(s) or group of programs, consistent with corporate & portfolio strategy [*together with x-functional experts from research, translational, regulatory, clinical, manufacturing, medical affairs, IP, communication, quality (compliance) and commercial].
- The Program Lead is responsible for leading the program and program team to achieve the objectives in accordance with quality standards and within timelines validated with governance.
- The program lead ensures oversight of the Program budget, while functional heads are accountable for ensuring delivery within budget.
- Is responsible for ensuring that all activities related to the program(s) are conducted:
- Within the framework of the agreed asset strategy and the overall strategic objectives of the Company,
- With cross-functional alignment of Research, non-clinical & clinical, Manufacturing & Commercial, IP, communication, quality (compliance) representatives,
- In compliance with the state-of-the-art and external regulations in force, and good project management practices.
- At all phases of planning and implementation, the Program Lead ensures appropriate validation by and reporting to governance according to company processes.
**Main responsibilities and key tasks**:
**Program strategy, planning and execution**:
The Program Lead
- Owns the integrated strategy for the asset.
- Is responsible for defining and delivering the integrated program development plan by coordinating all key functions (science, regulatory, clinical, manufacturing, commercial, communication, IP, quality) related to the asset/program.
- Is responsible for ensuring the validation of integrated development plan by key stakeholders (senior management/stakeholders and external experts/customers).
- Ensures cross-functional engagement / way of working to ensure full team alignment and utilizing every member of the team to execute the program strategy.
- Responsible for the robust assessment of opportunities, risks, in conjunction with the key function leaders, in order to maximize value of the asset/program.
- Responsible to set up backup scenarios, as well as « go/no go decision points » to mitigate risks and to present them to Governance meetings.
- Drives implementation of the plans whilst managing risks.
- Develops and recommends strategic options to governance.
- Oversees the program budget and ensure it fits with the strategic needs and agreed roadmap in conjunction with finance and expert functions.
- Responsible for appropriate internal communication to Program team and stakeholders.
- Contributes to and adopts relevant aspects of the company’s portfolio management process.
**Communication**:
The Program Lead engages in regular, competent and active communication with key stakeholders as a representative of the company both internally and externally (congress, partnering, and negotiation).
The Program Lead is responsible for defining & implementing Program internal & external communication plans:
- Proposing and conducting communications concerning the results of both scientific and clinical studies in association with the cross-functional team.
- Ensuring consistency across Program messages for external communication.
**Documentation**:
Key program deliverables, developed with cross-functional expert team, include:
- Integrated cross-functional development strategy, objectives & plan, consistently with Target Product Profiles & key value drivers.
- Status Updates for Management e.g. dashboards, reports, highlights at governance, other.
- Program Risks/opportunities and mitigation plans.
- Go/no-go criteria & scenario plans against all ongoing activities.
- Key Decision Points documentation.
The Program Lead contributes to key functional Project documentation & deliverables as required by governance, Quality, compliance & PMO guidance, such as the Clinical trial documents, IND file, investigator's brochure, Briefing Documents, scientific publications, scientific collaborations work plans, documentation to support CDMO key decision points, documentation for HA interactions, etc...
**Experience and Qualifications**:
- PhD or equivalent degree+ or more than 10 years in pharmaceutical industry as a program lead.
- Proven experience in the field of biologics and oncology/hematology. A thorough knowledge of the pharmaceutical business model, of the value chain, especially in a Health Care environment.
- Experience of working with rese
