About this Position:
Armata Pharmaceuticals is seeking a highly motivated and dynamic Director of Clinical Development to lead the planning, execution, and management of our clinical trials. This key role ensures the safety, efficacy, and successful development of our innovative products. The ideal candidate will serve as a vital link between scientific research, regulatory compliance, and business objectives, driving the organization’s clinical strategy forward. This position requires a unique combination of scientific expertise, strategic vision, and leadership skills to advance transformative therapies from concept to market.
This full time role will be 100% onsite and will report to the Chief Executive Officer.
Job Description and Technical Requirements:
- Provide medical input for all aspects of product development, for new and innovative treatments being developed in patients.
- Serve as scientific and medical member for clinical team(s) working closely with clinical project lead, the regulatory lead, and the operational lead(s) for overall programs within the therapeutic area.
- Develops clinical study concepts based on thorough scientific review and consultation with internal and external experts as well as senior scientists and acts as author/developer of clinical summary and other supporting documents for regulatory submissions and for publications.
- Collaborate with colleagues in clinical development and operations, research, manufacturing and quality, regulatory affairs, and product safety to participate in protocol development and study design, statistical analysis plans, CRO selection and management, site monitoring, safety, clinical support of regulatory interaction, study reporting for products that will ensure regulatory approval and commercial success.
- Ensures that study design is scientifically robust, suitable to evaluate the trial's hypothesis, and likely to meet the objectives of the study while ensuring the safety of the patients participating in the Company’s sponsored clinical trials.
- Interact closely with the pre-clinical team to understand the scientific basis of targeted therapy and the relationship to clinical practice decision-making.
- Provides medical guidance for the design of biomarker studies and provides a medical perspective to biomarker data interpretation.
- Collaborate with clinical pharmacology to interpret pharmacokinetic and toxicokinetic data and the implications for clinical study design and outcomes.
- Responsible for medical components of the design, execution, and reporting of study protocols as well as (in collaboration with other clinical and regulatory team members) labeling and regulatory communications.
- Directly develop or guide the development of scientific/medical portions of clinical study reports, safety reports, regulatory submissions to ensure production of high-quality deliverables.
- Directs protocol implementation, including site identification, through communication with site investigators and their staff.
- Leads site initiation meetings and follow-up meetings with investigators.
- Supports analysis and assembly of safety and efficacy data from Company’s clinical trials.
- Contributes to the preparation of abstracts, presentations, and manuscripts.
- Organize clinical advisory boards, steering committees and data safety monitoring boards as required.
- Acts as primary developer of clinical content for communications with regulatory agencies and IRBs/ethics boards.
- Ensures the feasibility of the study by incorporating study design elements that are ethical and consistent with standard of care and applicable local practices.
- Responsible for establishing and maintaining communications with prominent clinical investigators in his/her field of expertise.
- Works with international colleagues and with external alliance partners on clinical and regulatory initiatives and issues
- Serves as a technical resource to the Company regarding the medical science of the field and the current state of treatment in areas of unmet medical need.
- Overseas and provides leadership to colleagues involved in clinical trial execution.
- Ensure consistent practices with the highest ethical standards in compliance with internal SOPs, local regulations, and laws.
- Performs other duties as assigned.
Qualifications and Experience:
- M.D. or D.O. with subspecialty and board eligibility/certification in infectious diseases or as an intensivist.
- Alternatively, experience in antibacterial drug development may substitute for this specialization.
- Minimum of 5 years of successful clinical research and/or drug development experience, particularly in biologics.
- Direct involvement in Phase 2, Phase 2B, and Phase 3 clinical development.
- Experience in clinical development within the pharmaceutical, biotechnology industry, or an academic medical setting.
- Deep understanding of the unique safety, clinical development, and regulatory requirements for biological products.
- Strong knowledge of GCP, ICH, CFR, and local regulatory guidelines for drug research.
- Familiarity with statistical principles and guidelines as applied to clinical trials.
- Proven ability to collaborate effectively across functional areas with a strong track record in collaborative environments.
- Excellent relationship management and influencing skills with internal and external stakeholders.
- Strong analytical and critical thinking skills with the ability to organize, interpret, and communicate complex information effectively.
- Demonstrated ability to think strategically and creatively.
- Adaptability to changes and modifications in project plans.
- Exceptional written and oral communication skills.
- Skilled in delivering clear and succinct presentations, both formal and informal.
- Recognized for intellectual strength, achievement, and contributions as a clinical scientist.
- High sense of urgency and mindfulness.
About Armata Pharmaceuticals, Inc.:
Armata is a clinical-stage biotechnology company focused on the development of pathogen-specific bacteriophage therapeutics for the treatment of antibiotic-resistant and difficult-to-treat bacterial infections using its proprietary bacteriophage-based technology. Armata is developing and advancing a broad pipeline of natural and synthetic phage candidates, including clinical candidates for Pseudomonas aeruginosa, Staphylococcus aureus, and other critical pathogens. Armata is committed to advancing phage therapy with drug development expertise that spans bench to clinic including in-house phage specific cGMP manufacturing.
Armata is proud to be an Equal Opportunity and Affirmative Action employer. We are committed to providing equal employment opportunities to all qualified applicants, regardless of race, color, religion, sex (including sexual orientation and gender identity), national origin, disability, protected veteran status, or any other characteristic protected by applicable federal, state, or local laws.
Pay: $250,000.00 - $275,000.00 - per year
Send cover letter and CV to: careers@armatapharma.com
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