LB Pharmaceuticals Inc

LB Pharmaceuticals is seeking its first Director of Medical Writing to establish and lead the medical writing function at a critical stage of clinical and regulatory advancement. Reporting to the SVP of Regulatory Affairs, this individual will be responsible for authoring, overseeing, and driving the strategy for key clinical documents (e.g., Investigators Brochure, Clinical Efficacy Summary, Clinical Safety Summary, etc.) in support of IND and future NDA submissions.

This is a highly strategic yet hands-on role requiring deep expertise in regulatory writing, strong cross-functional leadership, and the ability to build scalable processes in a lean environment. The Director will also be expected to utilize and optimize the use of AI-enabled tools to enhance writing efficiency, consistency, and quality across the organization.

Key Responsibilities
Regulatory & Clinical Writing Leadership
•    Lead the authoring, review, and approval of key clinical and regulatory documents, including: 
o    Clinical Study Protocols (Phases 1–3) 
o    Clinical Study Reports (CSRs) 
o    Investigator’s Brochures (IBs) 
o    Integrated Summaries of Safety (ISS) and Efficacy (ISE) 
o    Common Technical Document (CTD) modules (primarily Module 2 and 5) 
•    Ensure consistency, quality, and strategic alignment across all documents 
•    Translate complex clinical, statistical, and scientific data into clear, concise, and submission-ready narratives 

Function Build & Infrastructure Development
•    Establish and scale the Medical Writing function, including: 
o    Standard templates, style guides, and document standards 
o    Writing processes, workflows, and governance models 
o    Quality control and document review practices 
•    Select, onboard, and manage external medical writing vendors and consultants 
•    Define the long-term operating model for Medical Writing as the company approaches NDA and commercialization 

AI-Enabled Writing & Innovation
•    Evaluate, implement, and optimize AI-based tools to enhance medical writing productivity, accuracy, and consistency 
•    Establish best practices for responsible and compliant use of AI in regulatory writing 
•    Drive innovation in document development, including automation, data integration, and content reuse strategies 
•    Train cross-functional teams on effective and compliant use of AI-assisted writing tools 

Cross-Functional Leadership
•    Partner closely with Regulatory Affairs to align on submission strategy, timelines, and health authority expectations 
•    Collaborate with external Clinical Research Organizations and internal Clinical Development team to create, review and finalize protocols, clinical study reports, annual reports, and other similar documents 
•    Work with Biostatistics and Data Management to ensure accurate interpretation and presentation of data 
•    Engage Clinical Operations to ensure alignment between study execution and documentation 
•    Support responses to regulatory agency questions and interactions 

Project & Timeline Management
•    Lead document planning and timeline development aligned with clinical milestones and regulatory submissions 
•    Coordinate cross-functional contributors and reviewers to ensure efficient document development 
•    Identify risks and proactively manage competing priorities in a fast-paced, milestone-driven environment 

Qualifications
Education & Experience
•    Bachelor’s degree is required. Advanced degree desirable but not required such as PhD, PharmD, MD, or equivalent in life sciences or Master's degree with 5+ years of relevant experience.
•    5-10 years of medical writing experience in the biopharmaceutical industry 
•    Demonstrated experience leading medical writing activities for both IND and NDA submissions 
•    Strong experience supporting Phase 2 and Phase 3 clinical programs 
•    Prior experience in a late-stage or pre-commercial biotech environment strongly preferred 
•    CNS or neuropsychiatric therapeutic area experience is a plus 

Technical Expertise
•    Deep knowledge of ICH guidelines, GCP, and global regulatory requirements 
•    Expertise in CTD structure and regulatory submission processes 
•    Proven ability to synthesize complex clinical and statistical data into clear narratives 
•    Experience with electronic document management systems and submission tools 
•    Hands-on experience using AI tools (e.g., generative AI, document automation platforms) in medical writing or related workflows 
•    Understanding of risks, limitations, and compliance considerations for AI use in regulated environments
•    Ability to balance innovation with regulatory rigor and data integrity 

Core Competencies
•    Exceptional writing, editing, and communication skills 
•    Strong strategic thinking combined with attention to detail 
•    Excellent project management and organizational abilities 
•    Ability to influence cross-functional stakeholders without direct authority 
•    Builder mindset with the ability to create and scale a function from the ground up 

The posted salary range reflects the minimum to maximum base pay for this position in the specified location. Actual compensation may vary based on factors such as geographic location, experience, education, licensure requirements, and skill level, and will be determined at the time of offer. Base Salary Range: $220K-$235K.

The Values We Hope You Share  

1. Purpose Driven– We are optimistic, focused and committed to delivering on our vision. We are hard-working, compliant, relentless and impatient in our pursuit of treatments. We set competitive company goals to significantly and positively impact the lives of our patients, employees and shareholders. We have a sense of urgency to every action we make.  

1. Transparent – We trust each other and expect honest and open communication to enable good decision making. We are humble, genuine and direct. Words match our behaviors. We hold each other accountable. We embrace the tough conversations to achieve success.
   

1. Bold – We are courageous in our pursuit of excellence. Unafraid of risks. Unafraid of challenging assumptions. Unafraid of challenges. Unafraid of success.
   

1. Intelligent – We are curious, passionate and self-aware. We are agile, adaptable and seek diverse experience, knowledge, and skills to make informed, data driven decisions. We anticipate the needs of others, and we adapt quickly to challenges and find solutions. We rely on our collective experiences to diligently develop, strategically plan and efficiently execute our vision. 
   

1. Unified – We collaborate as we strive for excellence. We rely on each other, and we have each other’s backs. We encourage constructive feedback to continually improve. We support each other; we laugh together. We celebrate each other’s successes and band together in times of hardship. We foster and appreciate genuine relationships.
   

Our values underpin the employee experience at LB Pharmaceuticals. They are the character and personality of the company demonstrated through how we communicate, support one another, spend our time, make decisions, and celebrate collectively.