VP, Regulatory Affairs Strategy

The posting, as 4D Molecular Therapeutics wrote it

Attention recruitment agencies: All agency inquiries are vetted through 4DMT’s 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 Company’s 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 biologics (aflibercept and anti-VEGF-C) with a single intravitreal injection, which substantially reduces the treatment burden associated with current bolus injections. The Company’s lead indication for 4D-150 is wet age-related macular degeneration and the second indication is diabetic macular edema, which are both in Phase 3 development. The Company’s 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.

We are taking genetic medicine to new heights and into new disease areas to overcome challenges not addressed by existing medicines. This incredible challenge drives our relentless and talented team. Our people are the essence of our inspiring, innovative and collaborative environment that encourages individual contributions and provides opportunities for career development. We seek the best in the industry who identify with our mission and our bold and innovative results-driven approach. Our Core Values drive the way we work together:

• Dare to Cure
• Break Boundaries
• Beyond Yourself
• Prepare & Execute Relentlessly

Join us in creating the future of genetic medicine.

GENERAL SUMMARY

4D Molecular Therapeutics (4DMT), located in Emeryville, CA, is a clinical-stage biotechnology company developing targeted genetic medicines using its proprietary AAV vector platform to treat serious unmet medical conditions. The Vice President, Regulatory Affairs Strategy, reporting to the Chief Regulatory and Quality Officer, is the company’s senior global regulatory strategist, accountable for designing and executing integrated US, EU, and international regulatory strategies that take 4DMT’s programs from IND through BLA/MAA and approval in major markets. The role sets regulatory direction on program and executive teams, leads the company’s most consequential interactions with FDA, EMA, and other health authorities, and leads the Regulatory Strategy team.

MAJOR DUTIES & RESPONSIBILITIES

• Develops and leads integrated global regulatory strategies (US, EU, UK, Japan, and other key markets) for 4DMT’s AAV gene the

[…]
issions, including a BLA or MAA, required.

• Excellent organizational, communication and time management skills are required
• Must be able to innovate, analyze and solve problems with minimal supervision and strong attention to detail.

Travel: 15-25%, including international travel. Hybrid or on-site role, expected to be on site in Emeryville, CA at least three times a month.

Physical Requirements and Working Conditions

• Physical Activity - Repetitive motions: Making substantial movements (motions) of the wrists, hands, and/or fingers. Fingering: Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling. Talking: Expressing or exchanging ideas by means of the spoken word.
• Physical Requirements - Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally, and all other sedentary criteria are met.
• Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work).

Base salary compensation range: $326,000 - $381,000

Please note, the base salary compensation range and actual salary offered to the final candidate depends on various factors: candidate’s 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