Director, Medical Writing
- Employer
- 4D Molecular Therapeutics
- Location
- Emeryville, CA
- Start date
- Jun 25, 2021
View more
- Discipline
- Clinical, Medical Writing
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Biotech Bay
Job Details
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 competitive salary and benefits, and provides challenging opportunities for career development. 4D Molecular Therapeutics is located in Emeryville, CA.
GENERAL SUMMARY:
The Director, Medical Writing is the lead medical writer for the group and will manage the function; 75% will manager your own writing and 25% will manage the writing of others. This role will be responsible for managing all external medical writing vendors and will manage systems and procedures for document writing. Accountable for overall process including SOPs, review function and approvals with cross functional groups including Regulatory Affairs. Manages the overall operations of a team or major project and implements this through effective leadership. The Director provides guidance and leadership for document development for regulatory filings and coordinates the clinical sections of more complex regulatory submissions, including organization, content, and resource requirements. The Director applies advanced technical expertise and develops solutions to complex problems, fosters interdisciplinary understanding, and integrates Medical Writing department activities with those of other departments.
Responsibilities:
- Collaborate with key stakeholders to ensure understanding of program strategy and the nature of medical writing services required to deliver on program objective
- Proactively anticipate risks, solve complex problems, and seek out and implement process improvements
- Independently prepare clinical regulatory documents, including protocols, study reports, investigator’s brochures, and sections of regulatory submission
- Provide medical writing input for study designs and statistical analysis plans
- Thoroughly analyze and critically interpret data to determine the best approach to composing each document
- Provide expert-level input to cross-functional teams that work on standard operating procedures, process improvements, and integration of new tools and technologies
- Identify new technologies and initiatives related to the preparation of clinical documents, provide well-informed recommendations, and facilitate integration into department processes
Qualifications:
- Bachelors degree and strong relevant work experience required Experience:
- 5+ years experience heavy medical writing in an in-house role within the Biotech or similar industry
- Experience writing clinical regulatory documents
- Gene therapy experience and/or rare disease therapeutic areas a plus but not required Skills:
- Ability to analyze, interpret, and summarize moderately complex data
- Broad understanding of drug development, clinical research, study designs, biostatistics, pharmacology, regulatory requirements, and medical terminology.
- Advanced computer skills related to word processing, templates, table/figure creation, literature searches, electronic review systems, and document management systems; can act as a resource for others for these tools.
- Superior written and verbal communication skills Physical Requirements of the Role:
- Sitting for long periods of time using a computer
- Adhere to 4DMT COVID protocols and policy
- During the current COVID-19 pandemic, the ability to work remotely until it is safe to return to the worksite and work onsite once 4DMT deems it safe to return.
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
Company
4DMT is a gene therapy company with a transformative discovery platform --Therapeutic Vector Evolution --that enables our “disease first” approach to product discovery and development, thereby allowing us to customize our AAV vectors to target specific tissue types associated with the underlying disease.
At 4DMT we are creating and developing optimized “biopharmaceutical grade” AAV vectors that will allow us uniquely to unlock the full potential of gene therapy. Our customized and proprietary AAV vectors are each designed, according to a 4DMT Target Vector Profile, to deliver genes to specific cells and tissues in the body to eradicate both rare and large market diseases.
While AAV gene therapy pioneers are making great strides with the first wave of products, hurdles still exist with the use of conventional vectors. The most commonly used AAV capsids (e.g., AAV2, 5, 8 and 9) were identified either 1) as contaminants in lab stocks of adenovirus, or 2) through monkey tissue processing. Therefore, these conventional vectors are not targeted specifically to any tissue in the body. This can lead to inefficient and non-specific delivery, thus requiring extremely high doses and potentially resulting in toxicities (including inflammation), high manufacturing burdens and suboptimal efficacy. In addition, suboptimal routes of delivery can be required for delivery to the right tissues (e.g., subretinal delivery to the retina). Finally, pre-existing neutralizing antibodies in many patients can limit efficacy, clinical trial enrollment and market sizes. 4DMT Innovation empowers us to create new and improved next generation AAV capsids to allow targeted delivery of our products by the optimal clinical route of administration.
At 4DMT we use our robust discovery platform, termed “Therapeutic Vector Evolution,” to create customized and proprietary gene delivery vehicles (novel AAV vectors) to deliver genes to specific tissues and cells in the body by the optimal route of administration. We use the power of evolution to create and refine these optimized vectors through genetic diversification and then natural selection in vivo.
4D Purpose Statement: Boldly Innovating to Unlock the Full Potential of Gene Therapy for Countless Patients
GUIDING PRINCIPLES
- Dare to Cure - Patients are waiting. Create big dreams for patients and take calculated risks to achieve them
- Break Boundaries - Question the status quo and innovate beyond conventional approaches
- Beyond Yourself - It's about patients, their families, our team, our families. We strengthen each other.
- Prepare and Execute Relentlessly - Start with the end in mind, over-prepare and make contingency plans to your contingency plans
We invite all of you who share our passion and vision in creating the ultimate gene therapy products to cure genetic and rare diseases in children and adults. We seek 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 generous benefits and provides challenging opportunities for career development.
- Website
- http://www.4dmoleculartherapeutics.com/
- Phone
- 510-505-2680
- Location
-
5858 Horton St. Suite 455
Emeryville
California
94608
United States
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