Senior Clinical Program Manager M - W H/F Servier

The Senior Clinical Program Manager in the Oncology Therapeutic Area will play an instrumental role in working with teams to organize and advance critical programs.

The responsibilities include providing clinical program management support for the oncology therapeutic area (including both early and late-stage development teams), responsible for setting clinical development strategy, providing operational and execution guidance, supporting the filing of pivotal clinical regulatory submissions, and resolving issues that affect the clinical development of a given compound or indication.

The Senior Clinical Program Manager will partner with the clinical development sub-team, generally including clinical, regulatory, biostatistics, clinical operations, medical writing, drug supply, safety, medical affairs, translational medicine/biomarkers and clinical pharmacology/DMPK representatives.

Responsibilities :

- Partner with clinical leads, direct manager, and cross-functional stakeholders within the Oncology Therapeutic Area team to coordinate cross-functional planning and execution of the clinical strategy, including the preparation of high-quality content for governance meetings.
- Lead program management activities, including setting clinical sub-team meeting agendas, documenting meeting action items and minutes, and ensuring transparent communication to maintain alignment between clinical sub-teams (CST), Core Team, Study Team, Medical Affairs, filing teams, and Management.
- Motivate and facilitate informed, timely, and impactful decision making across the organization.
- Manage short- and long-term clinical program planning including setting and tracking team objectives and milestones, identifying critical paths, assessing risk, developing mitigation plans, and tracking timelines, budgets, resources and progress as required for complex, global programs including major regulatory filings (e.g., NDAs/MAAs).
- Engage stakeholders at all levels of the organization to solicit input, feedback and incorporate learnings.
- Foster a high-performing team environment that promotes cross-functional engagement, cooperation, accountability, and constructive conflict management, proactively addressing challenges as they arise.
- Monitor and evaluate team performance and team health, proactively addressing interpersonal challenges to ensure teams are successfully, effectively and efficiently working together.

- Ensure clinical sub-teams (CST) effectively and efficiently achieve the following:
- Collaborate cross functionally to develop, define, establish, and oversee the clinical development strategy/plan for the program.
- Identify and evaluate risks to the clinical development strategy/plan and work cross functionally to mitigate risks.
- Contribute to Core Team goals by developing clinical goals. Drive achievement and monitor progress of Core Team /CST goals related to clinical development strategy/plan and study execution.
- Facilitate clinical sub team evaluation of critical clinical and translational data, endorse clinical interpretation, and assess implications on clinical development strategy (e.g., publications, interim/final analyses for business decisions and regulatory meetings).
- Track and review data cuts across studies, filings, and publications to introduce efficiencies when possible.
- Review and endorse the annual publication plan and monitor progress and execution of publications.

Profile :

- Bachelor's degree required, master's degree in relevant course of study and Oncology experience preferred
- Minimum of 6 years of multi-disciplinary clinical development experience at a biopharmaceutical company in areas of clinical development planning, execution, and reporting and/or regulatory submissions (INDs, NDAs, MAAs).
- Project Management Professional (PMP) certification preferred
- Proficiency in Microsoft Outlook, Word, Excel, PowerPoint, Project and Office Timeline Pro/Plus.
- Initiative and independence to identify short- and long-term program needs, creatively formulating plans with team input, achieve decisions/alignment and organize resources.
- Listens to understand, talks straight, drives clarity, makes sound and timely decisions with a high sense of urgency, and supports a learning environment.
- Demonstrates self-awareness, understanding and acknowledgement of own strengths and limitations and respecting others' preferences and expertise.
- Is recognized as a strong communicator and meeting facilitator.
- Excellent organizational skills.
- Excellent English written and oral communication skills.

Nous sommes engagés pour l'égalité des chances et le développement des talents dans toute leur diversité. Nous accordons autant de valeur à l'expérience qu'à l'envie de s'engager au quotidien pour être utile au progrès thérapeutique au bénéfice des patients. Si vous vous reconnaissez dans cette offre et ces quelques lignes, saisissez cette opportunité de nous rencontrer.