Senior Manager/ad, Clinical Sciences Early Development

**Job Function**:
Discovery & Pre-Clinical/Clinical Development
**Job Sub Function**:
Clinical Development & Research - Non-MD
**Job Category**:
Scientific/Technology
**All Job Posting Locations**:
Beerse, Antwerp, Belgium

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Our Oncology team is focused on the elimination of cancer by discovering new pathways and modalities to finding treatments and cures. We lead where medicine is going and need innovators with an unwavering commitment to results.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

USA - Requisition Number: R-037228

Belgium - Requisition Number: R-041967

Ireland - Requisition Number: R-042194

The Senior Manager / Associate Director, Clinical Sciences Oncology provides active scientific and strategic contributions and is responsible for contributing to the execution of clinical studies within the Therapeutic Area. This position involves collaborating with cross-functional teams, in close partnership with Study Responsible Physicians/Clinical Leads, to design, plan, and manage complex clinical trials, ensuring compliance with departmental, company, and regulatory standards. This role assists to contribute to the clinical development plan and involves in, the development of clinical trial protocols and materials, and supports the completion of clinical study reports, and supporting regulatory filings. As a core member of the clinical team, the Associate Director of Clinical Science manages matrix interactions among cross-functional members, assists to contribute to the evaluation of scientific opportunities, medical data monitoring, and drives process improvements to enhance trial efficiency and operational excellence. This role may manage direct reports, mentor colleagues, and foster a culture of continuous learning and development within the team.

The **Senior Manager/Associate Director, Clinical Sciences Oncology**has the following essential job functions:

- Contribute to the development and execution of clinical trial strategies and other study-related materials (e.g. case report forms, operational plans) and provide clinical representation for study-related review committees (e.g., protocol review committee).

- Contribute to the execution of clinical strategies for clinical trial protocols, ensuring compliance with scientific, organizational and regulatory standards.

- Oversee end-to-end delivery of a clinical trial protocol, including study design, initiation, medical data monitoring, data dissemination, and closeout activities.

- Contribute to the management and coordination of activities with internal functional partners and external partners to ensure timely scientific and clinical execution of a clinical trial. Contribute to the maintenance of the quality and integrity of clinical data, which is critical to the evaluation of study endpoints.

- Support interaction and collaboration with investigators and study teams during the conduct of the trial(s). Lead training on study protocol, disease evaluation criteria, and other essential components to enhance the understanding of clinical development processes.

- Collaborate with Study Responsible Physician to assess and evaluate clinical trial data (i.e. adverse events, labs, medications, etc). Establish and define medical data review plan in partnership with Study Responsible Physician. Performs medical data monitoring/reporting and evaluates ongoing clinical trial data.

- In partnership with Study Responsible Physician, act as a liaison between the company and clinical investigators, fostering collaborations with key opinion leaders and external advisors.

- Develop and maintain relationships with internal and external stakeholders, including research teams and regulatory representatives.

- Contribute to mentorship and training of junior team members, fostering a collaborative work environment.

- Actively engage in opportunities to enhance clinical development and therapeutic area expertise.

- Identify opportunities for process improvements and implement best practices in clinical trial execution.

- Drive innovative research methods and operational strategies to enhance clinical development efficiency.

- Collaborate with cross-functional partners to align clinical strategies with overall product development goals.

- May participate in governance meetings, as appropriate, and cross-functional initiatives to promote business strategies and process improvements.

- Prepare and present findings and results of clinical research at internal and external meetings, including regulatory body interactions.

- May act as an author of scientific publications, as applicable, to contribute to clinical development practices and adv