Director/Senior Director, Medical Writing

About the role

vTv Therapeutics is a clinical stage biopharmaceutical company focused on developing oral, small molecule drug candidates. vTv has a pipeline of clinical drug candidates led by cadisegliatin, a potential adjunctive therapy to insulin for the treatment of type 1 diabetes. vTv and its development partners are pursuing additional indications, including type 2 diabetes and other chronic conditions.

Key Responsibilities

• Provide strategic leadership and oversight of the Medical Writing function, ensuring the delivery of high-quality clinical and regulatory documentation.
• Establish document standards, templates, style guides, and best practices aligned with regulatory expectations (ICH, FDA, EMA).
• Oversee document planning, timelines, and resource allocation across programs to ensure on-time delivery of key regulatory and clinical deliverables.
• Lead identification and management of external medical writing vendors and consultants as needed.
• Maintain awareness of evolving regulatory guidance and industry best practices relevant to clinical and regulatory documentation.
• Serve as the medical writing lead for assigned development programs, partnering with clinical, regulatory, and statistical leaders providing strategic guidance and development to ensure clear and consistent scientific communications.
• Lead the preparation and review of major clinical documents as applicable, including: Clinical study protocols and protocol amendments, Clinical study reports (CSRs), Investigator brochures (IBs), Safety narratives, Scientific manuscripts and conference abstracts.
• Ensure scientific accuracy, clarity, and consistency across clinical documents. Collaborate with cross-functional teams to present complex clinical and scientific data into clear, regulatory-compliant documents.
• Manage clinical development processes and document archival requirements.
• Provide strategic input into regulatory submissions, ensuring consistency of messaging across documents and alignment with regulatory strategy. Support preparation of documents for regulatory meetings with agencies (e.g., FDA Type B meetings, End-of-Phase meetings, advisory committees) and major regulatory documents, including IND, CTA, NDA/BLA, and MAA submission components (e.g., ISS/ISE summaries, Module 2 documents, Clinical overviews, etc.).
• Serve as the strategic medical writing representative on program teams and development governance committees. Provide expert guidance on document strategy, messaging, and expectations.
• Contribute to corporate initiatives related to scientific communication, publication strategy, and document quality standards.
• Mentor internal staff and foster a culture of scientific rigor, clarity, and excellence in medical writing.
• Represent vTv on high impact/priority task forces across vTv or external to the company.

Educational and Experience Requirements

• Advanced degree preferred (MS, PhD, PharmD, MD, or equivalent scientific discipline preferred).
• 12–15+ years of medical writing experience within the pharmaceutical or biotechnology industry, CRO, or related environment.
• Extensive experience preparing clinical and regulatory documents supporting INDs and NDAs/BLAs.
• Demonstrated leadership of complex cross-functional writing projects and submission programs.
• Experience managing medical writing teams and external vendors preferred.

Skills

• Exceptional scientific writing and editing ability.
• Strong strategic thinking and problem-solving skills.
• Ability to translate complex scientific data into clear, concise, and regulatory-compliant documentation.
• Strong cross-functional leadership and collaboration skills.
• Excellent communication and interpersonal skills with the ability to influence multidisciplinary teams.

Knowledge

• Expert knowledge of ICH guidelines and global regulatory submission standards.
• Familiarity with FDA and EMA expectations for clinical documentation and regulatory submissions.
• Experience with word templates, electronic submission formats (eCTD) and document management systems.