Silverback Therapeutics, a Seattle-based biopharmaceutical company, is seeking a highly motivated individual to lead and drive strategy for clinical development of one or more of Silverback Therapeutics’ development candidates, and is responsible for the direction, planning, execution, and interpretation of clinical trials. This key leadership role establishes and approves scientific methods for design and implementation of clinical protocols, data collection systems and final reports including developing study protocols and other study documentation, and interpretation of clinical data.
- Lead clinical strategy while working to ensure cross-functional alignment on an ongoing basis throughout the phases of clinical development. Design study protocols and clinical development plans in collaboration with functional area and development teams.
- Provide medical/scientific, strategic, and operational expertise and support for the planning and execution of IND filings, early and late stage clinical trials.
- Provide expert opinion on the pathophysiology and diagnosis of disease, existing and emerging treatments and unmet medical needs to inform key medical and business decisions.
- Conduct medical monitoring of clinical trials; writes protocols, informed consent documents; respond to questions from regulatory agencies, institutional review boards and ethics committees; review clinical data, case report forms and ensure final accuracy of clinical trial data for clinical study reports. Participate in the selection of sites, CROs and vendors.
- Conduct safety monitoring, oversees conduct of clinical sites for adherence to both company standards, and government/industry regulations (GCP/ICH); support development of investigator brochures; train investigators and travel to clinical sites to build relationships with investigators and study teams in support of study enrollment.
- Institute and continuously improve operating procedures ensuring best practices.
- Establish appropriate strategic partnerships with centers of excellence, advocacy groups and KOLs in the areas of scientific interest.
- Collaborate closely with key stakeholders to ensure tight strategic integration of product development plans and strategies.
- Plan and develop content for advisory meetings with opinion leaders and for medical symposia.
- Participate in review of medical materials to ensure content is medically appropriate and compliant with internal and external requirements.
- Proactively identify clinical development risks and propose risk mitigations.
- Keep up to date on current relevant therapeutic areas through familiarity with literature, attendance at meetings, conventions, and professional associations.
- MD degree and 10+ years of clinical trials design/management experience in the clinical practice, academic and biotech/pharmaceutical industry.
- 3+ years of clinical trials experience within the biotech/pharmaceutical industry, including experience supporting oncology and/or immuno-oncology programs.
- US board certification or eligibility required.
- Experience in oncology and/or inflammatory disease drug development strongly preferred.
- This position requires up to 20% domestic travel and may include limited international travel (little travel is anticipated during the COVID-19 pandemic).
- Expertise in preparing clinical regulatory documents and scientific publications is crucial.
- Excellent written and verbal communication skills essential.
- In-depth experience with and understanding of early-stage clinical development programs, including proof-of-concept, Phase 1, Phase 2, and through later development.
- Good knowledge of FDA and ICH regulations and industry standards applicable to the design and analysis of clinical trials.
- Demonstrated thorough understanding of other cross-functional departments/disciplines and how they contribute to the drug development process.
- 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.
- 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 ImmunoTAC 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 email@example.com. We are an equal opportunity employer.