Position Summary: 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.
Key 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.
- Facilitate Clinical Development goals and achievement of study quality metrics.
- Interfaces with various functions, including Regulatory, Clinical Operations, Drug Safety, Medical Affairs, and Legal.
- Assists with the tracking of (in- or outsourced) study programs, collaborating actively with Clinical Operations, Drug Safety and vendors; activities include site selection, collection and analysis of clinical data, reporting and providing ongoing medical monitoring for clinical trials (eg, assessment of eligibility criteria, managing protocol-related questions, and clinical safety data surveillance)
- Stay up to date on current information regarding regulations and guidelines for the therapeutic area and scientific advances in the relevant field
- Stays abreast of clinical and drug development information relevant to our products, including attendance to medical or scientific meetings, monitoring external competitor landscape and personal interactions with consultants and investigators
- Provides medical oversight of the implementation of clinical trials
- Maintains a working knowledge of projects in his/her functional area
- Provides therapeutic and protocol-specific scientific training to project teams and new hires
- Assists with (internal) legal inquiries on the science related to our products
- Participates in the design and review of study-related documents and professional abstracts and manuscripts
- Maintains a high level of expertise engaging key opinion leaders and investigators through impactful participation in internal meetings and attendance at professional seminars, advisory boards, workshops and educational programs
- 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). ,
- Provides strategic planning and assists with the preparation of clinical development plans.
- Assists with business development due diligence activities.
- Assists with authoring and/or reviewing relevant Pre-IND, IND, and BLA sections and generating responses to information queries.
- Ensures adherence to regulatory requirements of study conduct and industry standards of Good Clinical Practice
Qualifications:- 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
- Clinical or research experience in this field of specialization is highly desirable.
- 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 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 working with personnel with varied professional (technical and educational) backgrounds
- Experience in cultivating novel business contacts and projects via interpersonal skills
- Must have excellent verbal and written communication skills in English
- Willingness to travel 10-15% of the time, including travel to key medical conferences and study-related events such as investigator meetings.
#LI-Hybrid
The position is eligible for competitive compensation and benefits package.
Zenas is committed to fair and equitable compensation practices. The base salary pay range for this role is $240,000 to $300,000. Actual compensation packages will depend on various factors, including, but not limited to depth of experience, education, skillset, overall performance and/or location.
Zenas believes in providing a competitive compensation and benefits package to all employees. Our base salary is just one component of Zenas' competitive total rewards strategy that also includes annual performance bonus, equity, full range of benefits and other incentive compensation plans.
