T2307 - Clinical Scientist Consultant - 6 Months

vor 3 Wochen

Lausanne, Schweiz Debiopharm Vollzeit

**_Debiopharm_**_ is an independent biopharmaceutical company based in Switzerland with an ongoing commitment to research in oncology and infectious diseases in order to improve patient outcomes and quality of life. Our main activities include drug development, drug manufacturing and digital health investment. Debiopharm International SA aims to develop innovative therapies that target high unmet medical needs. Our unique “development only” business model allows us to act as a bridge between disruptive discovery products and patient access in international markets. We first identify high-potential compounds for in-licensing, clinically demonstrate their safety and efficacy and then select large pharmaceutical commercialization partners to maximize patient access globally._

For our Clinical Development organization based at our Headquarters in Lausanne, we are looking for:
**Consultant, Senior Clinical Scientist Oncology (6 months)**

In this role, you will provide support to the Clinical Scientist team by driving the development of protocols & protocols amendments for clinical studies (Phase 1 to 3) in the Oncology Field.

**Your responsibilities will be but not limited to**:

- Drive development of protocols/protocol amendments for clinical studies
- Prepare and/or provide input to clinical study related and other regulatory documents (e.g. CSRs, IBs, PIS/ICFs, SAPs, Data Management Plans, Safety Management Plan, Medical Monitoring Plan, SRC Charter, IND, briefing books)
- Work closely with clinical team members within the assigned project to execute activities associated with the conduct of clinical trial
- Contribute to development of end-to-end clinical development strategy
- Prepare and/or provide input to clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, regulatory responses)
- Monitor, review and interpret safety and efficacy data of ongoing clinical trials
- Act as (clinical science expert) liaison to cross-functional project core team, clinical study teams, CRO's, study sites and others
- Establish relationships with investigators, KOLs, partners and appropriate consultants
- Provide clinical scientific input to business development (e.g. due diligence) and marketing activities
- Perform literature research
- Develop and deliver presentations to internal and external stakeholders. Provide input in scientific communication plan and scientific publications

**Requirements**:

- Master's in Life Sciences, Pharmacist or PhD in Life Sciences (preferred)
- At least 7-10 years of relevant experience in clinical development within the pharmaceutical industry, including development of CDPs and protocols
- Experience in **conducting Clinical Studies in Oncology**:

- **Experience in Prostate Cancer**:

- First experience working on studies in Anti-infectives in an asset
- Broad experience in the principles and techniques of data review, analysis, signal detection, interpretation and clinical relevance
- Well-versed in medical aspects of GCP, ICH, FDA, EMEA and other relevant guidelines and regulations
- knowledge of the multidisciplinary functions involved in drug development process (e.g.: clinical operations, biostatistics, regulatory, business, etc.) and can proactively integrate multiple perspectives into the clinical development process for best end-results.
- Driven and proven abilities to perform responsibilities independently and with limited guidance
- Excellent project management skills: can prioritize multiple tasks and goals to ensure the timely, on-target and within-budget delivery. Focused on results, flexible and open-minded, able to adjust to changing circumstances.
- Strong interpersonal, verbal/written communication, negotiation and influencing skills in English
- Proven track record of effective decision-making: makes good business decisions and exercises sound judgment
- Proven teamwork skills: has a proven track record of working highly effectively, efficiently and collaboratively with multidisciplinary teams. Demonstrate curiosity and challenge status-quo

**Benefits**
- Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the external staffing agency or recruiter does not create any implied obligation on the part of Debiopharm._

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