Senior Director, Clinical Science

Attention recruitment agencies : All agency inquiries are vetted through 4DMTs internal Talent Acquisition team. No unsolicited resumes will be accepted. The 4DMT Talent Acquisition team must expressly engage agencies on any requisition. Agencies contacting hiring managers directly will not be tolerated and doing so may impact your ability to work with 4DMT in the future.

4DMT is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients. The Companys lead product candidate 4D-150 is designed to be a backbone therapy forming the foundation of treatment of blinding retinal vascular diseases by providing multi-year sustained delivery of anti-VEGF (aflibercept and anti-VEGF-C) with a single safe intravitreal injection which substantially reduces the treatment burden associated with current bolus injections. The Companys lead indication for 4D-150 is wet age-related macular degeneration which is currently in Phase 3 development and second indication is diabetic macular edema. The Companys second product candidate is 4D-710 which is the first known genetic medicine to demonstrate successful delivery and expression of the CFTR transgene in the lungs of people with cystic fibrosis after aerosol delivery

GENERAL SUMMARY :

Reporting to the VP Clinical Science the Senior Director Clinical Science will play an integral role in facilitating successful advancement of ophthalmology gene therapy programs. The position supports clinical and scientific aspects of all assigned clinical programs.

MAJOR DUTIES & RESPONSIBILITIES :

• Partner with cross-functional program team members and key R&D stakeholders to support the development of innovative study designs clinical trial protocols and amendments investigator brochures and other documents required to conduct clinical trials
• Provide clinical support for clinical study conduct including operational feasibility data management communication plans safety and medical monitoring preparation of meeting materials and study updates.
• Provide scientific support and cleaning / querying of key safety and efficacy data for ongoing clinical trials throughout conduct
• Prepare and communicate clear overviews of trial results.
• Identify issues related to study conduct and / or subject safety. Provide preliminary assessments and recommendations and collaborate with the clinical team to develop solutions ensure resolution.
• Interact with internal and external stakeholders (study sites vendors KOLs etc.) in support of program-level strategy as well as clinical trial objectives
• Act as recognized clinical expert for assigned programs.
• Contribute to the preparation of medical and scientific data for publications presentations and study milestones (including meetings for Executive Team Board of Directors Advisory Boards and Data and Safety Monitoring Committees DSMC)
• Together with Medical Director of Ophthalmology serve as a point of contact for the clinical operations personnel clinical trial sites and CROs for clinical science questions
• Maintains knowledge of ICH-GCP and FDA IND and external regulations and procedures.
• Contribute to authoring clinical documents such as protocol synopsis clinical study reports IBs ICFs training documents and other clinical documents.
• Author pertinent clinical sections of regulatory filings including preparation of routine correspondence and sections of INDs BLAs NDAs Annual Reports Amendments Supplements Orphan Drug Applications and other regulatory submissions
• Other duties as assigned nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time

QUALIFICATIONS : Education :

Experience :

Other Qualifications / Skills :

Travel : 10%

Physical Requirements and Working Conditions :

Base salary compensation range : $268000 / yr - $341000 / yr

Please note the base salary compensation range and actual salary offered to the final candidate depends on various factors : candidates geographical location relevant work experience skills and years of experience.

4DMT provides equal employment opportunities to all employees and applicants for employment without regard to race color religion gender sexual orientation national origin age disability genetic information marital status status as a covered veteran and any other category protected under applicable federal state provincial and local laws.

Equal Opportunity Employer / Protected Veterans / Individuals with Disabilities

Required Experience :

Exec

Key Skills

Accounting Software,Access Control System,B2C,Banqueting,Jewellery,Linux Administration

Employment Type : Full-Time

Experience : years

Vacancy : 1