Zenas BioPharma
Medical Director, Clinical Development, Neurology
Waltham, MA · Director
Sponsorship not specified$10k-$15kDetected 40 days ago
Business DevelopmentCompensationClinical TrialsClinical ResearchPatient CarePharmacovigilanceResearchAnimal StudiesLeadershipCommunicationGxP
About the role
- The Medical Director, Clinical Development, Neurology, will assist in the development and execution of key activities of the Neurology Therapeutic Area in the Clinical Development department.
- The Clinical Development team is responsible for Phase I-III clinical research and supporting the company with medical and scientific knowledge for the therapeutic area.
- The Director will serve as a key resource to the VP of Clinical Development, Neurology, and as a medical expert to the company relating to products advancing through the various phases of drug development.
Responsibilities
- Provide support to the VP of Clinical Development, Neurology in a variety of projects and responsibilities (detailed below).
- Assists in the generation of study protocols/amendments, design and execution of clinical study programs, and review and interpretation of study results.
- Maintains a working knowledge of projects in his/her functional area
- Participates in the design and review of study-related documents and professional abstracts and manuscripts
- Assists with the preparation and/or review of data listings, summary tables, study results, study reports, and clinical/regulatory/safety documents (e.g., investigator brochures).,
- Obexelimab, Zenas' lead product candidate, is a bifunctional monoclonal antibody designed to bind both CD19 and FcγRIIb, which are broadly present across B cell lineage, to inhibit the activity of cells that are implicated in many autoimmune diseases without depleting them.
Requirements
- Clinical or research experience in this field of specialization is highly desirable.
- Experience in pharma-related clinical research and patient care or investigational site experience desirable
- Experience in analysis and interpretation of clinical data (safety and efficacy).
- Demonstrable experience in writing or editing reports of scientific research, either for regulatory submission or for scientific publications
- Ability to work in a fast paced, cross-functional, team-oriented professional environment
- Experience in cultivating novel business contacts and projects via interpersonal skills
- Must have excellent verbal and written communication skills in English
- MD, or MD with a PhD with post-graduate training and experience. Neurologist preferred but other relevant medical specialties (e.g. Psychiatry) can be considered with significant neuroscience/multiple sclerosis clinical trial experience
- Minimum of 3 years of clinical trial/research experience in an industry setting; Phase 3 clinical development and execution experience is strongly preferred.
- Hard working, driven to achieve sound results
- Experience working with personnel with varied professional (technical and educational) backgrounds
- Willingness to travel 10-15% of the time, including travel to key medical conferences and study-related events such as investigator meetings.
Nice to have
- MD, or MD with a PhD with post-graduate training and experience.
- Minimum of 3 years of clinical trial/research experience in an industry setting
- Phase 3 clinical development and execution experience is strongly preferred.
Compensation
- The position is eligible for competitive compensation and benefits package.
Benefits
- Interfaces with various functions, including Regulatory, Clinical Operations, Drug Safety, Medical Affairs, and Legal.
- Provides medical oversight of the implementation of clinical trials
Company info
- We are seeking top talent who share our commitment to patients and have a track record of success in acquiring, developing and commercializing products across the globe.
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