P2266 - Medical Writer & Clinical Scientist Group

vor 3 Wochen

Lausanne, Schweiz Debiopharm Vollzeit

Description

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.

At Debiopharm you will be at the forefront of the fight against cancer and infectious diseases, and you will have the opportunity to work on new innovative medicines for patients. Efficiency is our mode of action, saving lives our collective target.

For our Clinical Development Department based in Lausanne, we are looking for a:
Medical Writer & Clinical Scientist Group Head

The Clinical Scientist & Medical Writer Group Head (CS&MW GH) contributes to the development (from First in Human to Phase III) of Debiopharm promising molecules into innovative drugs in the Oncology and Antibiotics fields by acting as a leader of clinical science and medical writing support strategies.

The CS&MW Group Head is responsible for the supervision and competency development of a team of Clinical Scientists and Medical Writers (about 9-10 people). The roles of Clinical Scientists and Medical Writers include but is not limited to participation in the development of the Clinical Development (CD) strategy and plan, providing medical writing support and supporting the assigned Medical Director with various deliverables necessary for effective and efficient CD plan execution for the assigned molecule(s)/indication(s). The CS&MW GH facilitates the allocation and balancing of resources across clinical development programs and studies ensuring appropriate planning and tracking of activities across the portfolio in alignment with the Head of Clinical Development and other key stakeholders.

As CS&MW Group Head, you drive the strategy, development and execution of Clinical Scientists & Medical Writers Excellence, in compliance with Debiopharm processes, ICH GCP and regulatory requirements. You will support the Clinical Development Head and help to progress how Debiopharm innovates, engages and operates.

As Group Head and People Manager of CS and MW, you promote a positive organizational culture, direct, oversee and coordinate the activities and deliverables of Clinical Scientists & Medical Writers ensuring the achievement of program and department goals.

Your responsibilities will be but not limited to:
Selects, recruits, develops, manages, motivates, coaches and appraises the performance of direct reports to ensure high quality results and support career progression through quality development plans
Manages Medical Writers and Clinical Scientists workload and ensures the proper allocation of resources to projects and studies to meet company objectives and priorities
Provides all necessary support to help address and resolve issues. Identifies solutions for remediation
Builds and establishes a strong team spirit and positive organizational culture, and creates a team founded on clinical, scientific and medical writing expertise, quality, technical ability, excellence in performance and exhibiting Debiopharm values and winning behaviors
Acts as a Senior Clinical Scientist on programs on an ad hoc basis
Leads and supports certain projects and initiatives whenever applicable (for example Project Review Board, compassionate use programs) and supports the establishment of technical and professional skills for the Clinical Scientist and Medical Writer group and ensure staff training is conducted and properly documented
May act as a Subject Matter Expert for key operational areas influencing Clinical Scientist or Medical Writer Group area and identifies areas for process improvement
In collaboration with QA and Clinical Operations, manage audits and regulatory inspections related to clinical studies and create an audit readiness working environment. Understands Health Authority requirements and is able to participate in Health Authority inspections as required
Ensure high quality clinical trial data and Clinical Study Reports /outputs throughout the project life cycle, in compliance with Debiopharm processes, ICH GCP and regulatory requirements.
**Requirements**:
Master's Degree required, advanced Clinical/Science Degree is strongly preferred (e.g. PhD, MD, MSN, MPH, etc.)
Experience in Oncology and/or Infectious Diseases is a plus
7 years of relevant experience in clinical development within the pharmaceutical industry with focus on scientific, strategic and

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