Medical Director Clinical Science
vor 11 Stunden
**Sobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them. Our employees come from a variety of backgrounds within research, healthcare, industry and the academic sphere.**
**Medical Director Clinical Science**:
**Role & Function**
The main scope of work for the Medical Director Clinical Science is to oversee and manage all medical aspects of the clinical trials in the assigned therapeutic area. The Medical Director Clinical Science works in the Clinical Science team and reports to the VP RDMA Clinical Science and Medical Affairs. Key priority is to manage assigned Clinical Development Studies-projects from a medical perspective and contribute/author Clinical documents such as CSP, CSR, IB etc.
**Key Responsibilities**
- Provide medical and clinical science expertise for internal activities (clinical operations, regulatory affairs, pharmacovigilance and safety monitoring boards) and external activities (health authorities, ethics committees, research oversight and funding committees, key opinion leaders, investigators and patients)- The development of protocols, IBs, IMPDs, informed consent forms and other study related documents- Training of internal and external personnel on medical aspects of ongoing activities- Contribution to the development of presentation materials for advisory boards, investigator meetings, scientific congresses, company presentations etc.- Review of clinical trial data, providing expert analysis and interpretation and contribute to study reports and publications- Ensure high-quality Medical monitoring of clinical trial data- Interpretation of safety data in collaboration with pharmacovigilance and internal and external safety monitoring boards- Provide medical support for writing regulatory documents including but not limited to Briefing Books, HA presentations, INDs, submission packages- Provide medical leadership in the design of clinical trials and development programs-
- Represent Clinical science in appropriate matrix program teams- Overall medical responsibility for assigned studies- Participate in safety monitoring activities- Organize and lead DSMB meetings- Initiate and participate in feasibility assessments**Qualifications**
- Medical Degree- At least 5-10 years of clinical research experience in a pharmaceutical or contract research organization with a proven track record and innovative trial implementation and completion- Full understanding of GxP and especially GCP and GVP- Advanced medical writing and communication skills- Proven ability to interpret, discuss and present clinical data to critical audiences- Fluent in both written and spoken English; fluency in additional languages would be advantageous- Adherence to Company values (Commitment, Accountability, Responsibility, and Teamwork)- Proven ability to work independently and in a cross-functional team- Leadership and communication skills well developed- Can-do attitude and entrepreneurial spirit- Problem solver, individually and in working teams- Proactive and detail oriented**Personal attributes**
- Demonstrated leadership skills including e.g. build, lead and motivate workstreams/projects
- Ability to see a complex program from a "big picture"/strategic level
- Strong interpersonal skills with communicative and flexible attitude
- Excellent written and oral communication skills
- Good influencing skills and Interpersonal skills
- Excellent problem-solving skills, results and action oriented, hands-on
- Performs competently in a multicultural environment
In addition, you must demonstrate behaviors in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership.
**Location**
The position will be based in Basel, Switzerland.
**Sobi is an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, disability, age, sexual orientation, gender identity, or national origin. Sobi is committed to providing access, equal opportunity and reasonable accommodation for individuals with disabilities in employment, its services, programs and activities.
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