Senior Director, Medical Writing Job at Pliant Therapeutics, Inc. in South San F

Pliant Therapeutics is a late-stage biopharmaceutical company focused on the discovery and development of novel therapies for fibrotic diseases. Founded by Third Rock Ventures with world-renowned academic thought leaders, Pliant is raising the bar to meet the unmet medical needs of physicians, patients and families impacted by fibrotic diseases. As the leader in the discovery and development of novel therapeutics for the treatment of fibrotic diseases, Pliant is developing small molecule drug candidates specifically designed to impact the fibrotic process.

The Company's lead product candidate, bexotegrast (PLN-74809), is an oral small molecule, selective inhibitor of the ?v?1 and ?v?6 integrins that play a key role in multiple fibrotic pathways. Bexotegrast has received Fast Track Designation and Orphan Drug Designation from the U.S. Food and Drug Administration for both idiopathic pulmonary fibrosis (IPF) and primary sclerosing cholangitis (PSC) and Orphan Drug Designation from the European Medicines Agency in IPF and PSC. Pliant is currently conducting BEACON-IPF, a Phase 2b/3 trial of bexotegrast for the treatment of IPF.

Pliant is conducting a Phase 1 study for its third clinical program, PLN-101095, a small molecule, dual-selective inhibitor of ?v8 and ?v1 integrins, that is being developed for the treatment of solid tumors. The Company also has discovery and development programs in oncology and muscular dystrophies.

Description

Pliant is seeking an accomplished, creative and dedicated medical writer to contribute to the Company's mission of bringing forth therapies for patients with life-threatening fibrotic diseases. The medical writer will be responsible for writing and overseeing the completion of various regulatory and clinical/nonclinical documents. This person will work in lockstep with the cross-functional teams to ensure the documents are of high quality, completed in a timely fashion, compliant with SOPs, ICH/GCP/regulatory guidelines and aligned with company goals. The position will report to the Head of Clinical Development and will oversee all the regulatory and clinical medical writing activities for Pliant's development programs.

To be successful in this role, you must be able to communicate clearly (in verbal and written form) and display exemplary organizational / leadership skills. In addition, a successful candidate will support an environment in which the team is highly motivated and engaged to work collaboratively within their team and cross functionally to deliver exceptional results and ensure long-term success.

Responsibilities

• Build and lead the medical writing department by managing internal and external medical writers and assessing resource needs to meet the organizational goals.
• Establish key document development processes, standards and style guides in collaboration with a cross-functional team.
• Plan and lead submissions of clinical and regulatory documents (e.g., IND/NDA applications, protocols, eCTD clinical/nonclinical summaries/IMPD and briefing books)
• Develop and maintain SOPs relevant to medical writing function.
• Develop and maintain Company standard templates and best review practices for regulatory and clinical documentation; ensure vendors and contractors maintain company standard.
• Ensure smooth and effective document management from template to a final approved version.
• Ensure quality of documents or sections of documents prepared by functional area representatives as required and ensure adherence to standards and style guides.
• Oversee document review and comment resolution meetings with cross-functional teams.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty. The requirements listed below are representative of the knowledge, skill, abilities and prior experience required.

• Bachelor's degree in a scientific discipline required, advanced degree preferred.
• Minimum of 15 years of relevant clinical and regulatory writing experience; 12 years' experience with Masters or 10 years' experience with PhD.
• Minimum of 5 years of management experience.
• Solid understanding of the clinical development process, including the regulatory documentation that is required at each stage.
• Familiar with eCTD structure, and experience with eCTD summary documents (e.g. Modules 2.5 and 2.7) and/or regulatory briefing document.
• Demonstrated ability to develop effective strategies to ensure clear and concise messages and scientific concepts, including the ability to turn data into visuals that convey the key messages and to communicate complex information effectively and accurately.
• Strong leadership, planning and project management skills, along with initiative and ability of being productive with minimal supervision and support.
• Excellent oral and written communication skills.
• Flexible and adaptive work style to meet organization needs.
• Working knowledge of FDA, EMA and ICH regulatory guidance and regulations.

Pliant requires all new hires to be fully vaccinated prior to the first date of employment (subject to any legally required exemptions).

The annual base salary for this role is$260,000 - $280,000. Individual pay may vary based on additional factors, including, and without limitation job-related skills, experience, work location and relevant education or training. Pliant's compensation package also includes benefits, equity, and annual target bonus for fulltime positions.

To understand how Pliant complies with and manages your personal information with respect to the California Consumer Privacy Act, please visit https://pliantrx.com/ccpa-applicant-and-staff-privacy-notice/.