Medical Director

Location
Emeryville, CA, United States
Posted
Sep 04, 2020
Ref
514131054
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time

4D Molecular Therapeutics (4DMT) is a clinical-stage gene therapy company with a transformative discovery platform—Therapeutic Vector Evolution—that enables us to customize our AAV vectors to target specific tissue types associated with a wide range of underlying diseases, and to develop therapeutic products for a variety of diseases and therapeutic areas.

Our current pipeline includes two Phase 1 assets in monogenic ophthalmology indications, and a 3rd in patients with Fabry disease (a lysosomal storage disease with high unmet medical need). We also have therapeutics in wet AMD / diabetic retinopathy and in Cystic Fibrosis lung disease that have entered IND-enabling studies. We also have research candidates in the neuromuscular field.

4DMT is focused on attracting and retaining the best people in the industry who identify with our mission and innovative results-driven approach. We offer an inspiring and collaborative environment that encourages individual contributions, recognizes performance in multiple ways, offers uniquely generous benefits and provides challenging opportunities for career development. Join us in creating the ultimate gene therapy products to cure genetic diseases in children and adults. 4D Molecular Therapeutics headquarters are located in Emeryville, CA.

GENERAL SUMMARY:

Reporting to the CMO, the Medical Director is responsible for developing and executing global clinical strategy and tactical plans for a number of 4DMT Clinical Programs. This person will engage and establish credibility with the medical community and, working with the CMO, will ensure alignment and execution of internal and external priorities and activities.

The successful candidate must be a creative leader who adapts quickly to evolving circumstances and is able to succeed in a fast-paced environment.

The successful candidate will have a passion for innovative science, an affinity for strategic thinking, looking beyond the day-to-day execution, and will have a track record of keeping clinical programs on track and hitting milestones. The position will provide key overall clinical, scientific and/or logistical support to clinical development programs and is responsible for the compliance of the program to regulatory standards and procedures.

Responsibilities

  • Serve as the medical and clinical lead for one or more therapeutic product assets
  • Serve as the medical monitor for two or more clinical trials
  • Participate in defining and implementing clinical strategy for multiple therapeutic assets
  • Design trials and analyze, complete, write up and present trial data and updates
  • Provide data management support
  • CAB development, support and coordination
  • Establish relationships with key opinion leaders and ensure that significant developments in the field are identified and monitored; serve as the clinical lead for advisory meetings
  • Responsible for preparing clinical portions of regulatory documents including INDs, NDAs, investigator brochures, drug safety update reports, and clinical study reports
  • Accountable for clinical protocol development and preparation
  • Responsible for pharmacovigilance activities for clinical studies, including the review and reporting of SAEs (with support from the pharmacovigilance team)
  • Participate in the oversight and management of vendors/CROs
  • Prepare manuscripts and abstracts and make presentations at scientific meetings
  • Demonstrate clinical leadership of clinical trials (Phase 1-3) across therapeutic areas, ensuring that studies are carried out in accordance with the clinical development plan and regulatory authority requirements.
  • Help identify study sites and foster relationships with study investigators
  • Be the first point of contact with sites; answer site questions about eligibility, enrollment; safety and patient management
  • Chair internal and external clinical trial meetings-updating clinical staff and upper management on patient recruitment, trial issues, investigator feedback, patient enrollment issues and presenting a plan of action for resolution of issues
  • Production of clinical documents required for the conduct of clinical studies, such as clinical protocols (and amendments as needed), informed consent documents, investigator's brochures, and safety management plans in compliance with regulations and good clinical practices
  • Preparation of abstracts and posters for scientific meetings
  • Preparation of slides/ presentation at internal and external meetings, such as team meetings, Advisory Boards and Board of Director Meetings
  • Lead ongoing data interpretation to understand safety and efficacy profile of the investigation drug
  • Assist in preparation of clinical sections of key regulatory documents, e.g., IND annual reports and briefing packages
  • Present aspects of clinical program at Site Initiation Visits, Investigator Meetings and scientific conferences
  • Maintain state-of-the-art knowledge of the principles and theory in relevant therapeutic areas
  • Assist in case report form (CRF) development and data analysis plans
  • Perform in data cleaning and clinical study report review
  • Review and approve study materials such as CRFs, patient diaries, drug accountability forms, study reference manuals
  • Assist in generation and update of Clinical Development Plan (CDP)
  • Provide direct management, leadership and mentoring of other Clinical team members
  • Provide Medical/Clinical support to other functional areas
  • Participate in business development processes as needed, including due-diligence, and partnering activities
  • Perform all duties in keeping with the Company's core values, policies and all applicable regulations.
  • Perform other duties as required

 


Qualifications

 

 

  • MD required
  • Minimum of 5 years of clinical development experience in the pharmaceutical or biotechnology industries, and/or relevant clinical trial activities in the academic environment
  • Demonstrated understanding of FDA requirements, good clinical practices, and pharmaceutical clinical development
  • Demonstrated ability to contribute meaningfully to deliver clinical development strategy
  • Possesses an understanding of biostatistics and pharmacokinetics
  • Ability to work collaboratively in a dynamic team-based, matrixed environment
  • Experience leading and managing clinical development programs
  • Ability to travel domestically and internationally (when safe and permissible)
  • Working knowledge of the IND process; BLA experience a plus
  • In-depth knowledge of GCP/ICH guidelines preferred.
  • Proven ability to interact with different functional groups, investigators, key opinion leaders and the medical/scientific community.

 


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