Silverback Therapeutics, a Seattle-based biopharmaceutical company, is seeking a highly motivated individual to join our regulatory and clinical development team as a Director, Medical Writing. The successful candidate will be responsible for authoring and revising clinical and regulatory documents for submission to global Health Authorities, and to support other clinical communication efforts including abstracts and presentations for medical congress meetings and manuscripts for publication in peer-reviewed journals. This position will lead establishment of Medical Writing standards and best practices at a rapidly growing biotechnology company and serve as the Medical Writing lead on the regulatory, clinical development team(s), and publication planning team.
The Director, Medical Writing reports to the Head of Regulatory Affairs and is responsible for working cross-functionally with internal team members and stakeholders to develop, implement, and maintain a standardized document development process for nonclinical and clinical documents, regulatory submissions to US and other global health authorities, presentations, posters, and publications in peer reviewed journals.
- Prepare Investigational New Drug (IND) applications, amendments, annual reports, New Drug Applications (NDA) and/or Marketing Authorization Applications (MAA), and other documents to support global product development.
- Lead the development and authoring of nonclinical and clinical regulatory documents including: clinical protocols, clinical study reports, investigator brochures, safety updates, annual reports, scientific briefing documents, investigator brochures and nonclinical and clinical summaries in support of regulatory filings in collaboration with clinical study teams.
- Develop and manage timelines and resources for clinical and regulatory documents. Collaborate cross-functionally to drive projects to completion.
- Lead publication planning team in the strategic publication planning process and implementation of publication plans, including working with author groups to develop and author manuscripts, abstracts, and presentations for scientific congresses.
- Lead the development and authoring of abstracts and slides or posters presenting clinical study data at medical congresses and the development of primary manuscripts for publication in peer-reviewed journals including direct collaboration with internal and external authors.
- Coordinate/lead the activities of multiple contributors to medical writing projects/submissions.
- Organize, conduct, and lead cross-functional document development meetings.
- May oversee clinical library/information systems (Endnote).
- Interact closely with internal and external stakeholders in the development of statistical analysis plans and design of statistical outputs demonstrating advanced problem-solving ability.
- Routinely engage clinical development and biostatistics to gain comprehensive understanding of compound and the design, objectives, and results of clinical trials to enable accurate and effective communication to varied audiences.
- Represent medical writing on multiple study/project teams and contributes to program strategy, through collaborative engagement with personnel from other clinical disciplines, regulatory affairs, and scientific departments.
- Contribute to clinical trial registry postings and results disclosures on US and EU platform.
- Oversee the work of contract medical writers and other providers.
- Develop and implement templates, style standards, and standard operating procedures for clinical document production.
- Bachelor’s degree (or equivalent) in a relevant field, with advanced degree preferred, and 10+ years of biotech/pharmaceutical experience, including 3 to 5 years direct medical writing experience, an extensive portion supporting oncology and/or immuno-oncology programs.
- Experience in oncology and/or inflammatory disease drug development strongly preferred.
- Minimum of 3 years of successful management experience, including experience mentoring and managing the work of other medical writing and contract staff.
- Expertise in preparing clinical regulatory documents and scientific publications is crucial.
- Excellent written and verbal communication skills essential.
- Thorough knowledge of medical terminology required.
- Expert abilities in Microsoft Word, Excel, and PowerPoint; experience with Adobe Acrobat preferred.
- Demonstrated thorough understanding of other cross-functional departments/disciplines and how they contribute to the drug development process.
- In-depth understanding of regulatory/ICH guidelines and GxPs, Good Publication Practices (GPP) and related standards (e.g. CONSORT, ICMJE), and clinical trial transparency requirements (e.g. EudraCT, CT.gov).
- Familiarity with clinical trial transparency requirements, including ClinicalTrials.gov and EudraCT standards, preferred.
- Must have the ability to demonstrate flexibility and independently coordinate and prioritize multiple projects in a fast-paced, timeline-driven environment.
- Demonstrated ability to ensure a consistent style of document presentation to maintain quality and ease of review, and adherence to company standards.
- Excellent problem-solving and decision-making skills; provides strong critical thinking and constructive feedback.
- Proven ability to effectively collaborate with internal team and external collaborators, including ability to influence and reach compromises cross functionally to produce a quality document.
- A strong team player with a passion for science and helping discover and develop novel therapies for unmet medical needs.
Silverback Therapeutics, Inc. is a privately held, clinical-stage biopharmaceutical company focused on leveraging its proprietary ImmunoTACTM technology platform to develop systemically delivered and tissue targeted therapeutics for the treatment of cancer and other serious diseases. Silverback’s platform enables the strategic pairing of proprietary payloads that modulate key disease modifying pathways with monoclonal antibodies directed at specific disease sites. Initially, Silverback is creating a new class of targeted immuno-oncology agents that direct a TLR8 agonist myeloid cell activator to the tumor microenvironment in solid tumors to promote cancer cell killing. Silverback’s lead product candidate, SBT6050, is a therapeutic comprised of a TLR8 agonist payload conjugated to a HER2-directed monoclonal antibody that targets tumors such as certain breast, gastric and non-small cell lung cancers. SBT6050 is currently in a Phase 1 clinical study in patients with advanced or metastatic HER2-expressing solid tumors (ClinicalTrials.gov Identifier: NCT04460456). Silverback Therapeutics is located in Seattle, Washington. To learn more, visit www.silverbacktx.com.
We offer our employees competitive compensation and benefits, including paid time off, health insurance, life insurance, flexible spending accounts, a 401(k) plan, and stock options. Qualified candidates should forward their resumes to firstname.lastname@example.org. We are an equal opportunity employer.