Sound Biologics is a clinical-stage biopharmaceutical company dedicated to the discovery, development of next-generation MabPair, bispecific and multifunctional biotherapeutics. Sound Biologics are building a suite of complementary therapeutic platforms to precisely engineer and develop highly differentiated oncology and immuno-oncology product candidates.
The applicant will be joining a team of energetic, experienced scientists in a fast-paced and highly collaborative environment, building new technologies and platforms to produce the next generation of therapeutic antibodies that can target multiple molecules and pathways.
Requisite Skills and Abilities
- Proven interpersonal skills with the ability to work collaboratively as a member of a cross-functional team. Ability to establish and maintain effective working relationships.
- Strong leadership skills and the ability to lead through example.
- Experience in or knowledge about drug-development procedures. Industry/academic experience in planning, executing and reporting clinical trials is preferred.
- Deep understanding of the clinical trials process with demonstrated ability to have designed or co-designed and implemented programs and initiatives directed towards defined strategic objectives.
- Early-stage development and regulatory experience is preferable.
- Excellent organizational skills and the ability to manage concurrent deliverables and work effectively in a challenging, milestone-driven environment.
- Strong problem-solving skills and the ability to think and act strategically, pre-empt and prevent potential issues and map out next steps.
- Demonstrated high level of integrity, ethics and professionalism.
- Knowledge of scientific methods, research design and medical practices and procedures.
- Excellent written, oral and presentation skills. Demonstrated ability to communicate scientific results.
- Ability to travel.
- Provides medical/scientific, strategic, and operational expertise and support for the planning and execution of IND filings, Phase I trials, Phase II and potentially later stage trials.
- Provides expert opinion on the pathophysiology, diagnosis, existing and emerging treatment options and unmet medical needs to inform key medical and business decisions.
- Conducts medical monitoring of clinical development programs; either writes or works closely with a clinical CRO to produce clinical study protocols, investigator brochures, informed consent documents; responses to questions from regulatory agencies, institutional review boards and ethics committees and study reports; reviews clinical data, safety data, case report forms (including SAE or irAE) and ensures final accuracy of clinical trial data.
- Conducts safety monitoring independently or alongside CRO, including oversight of clinical site conduct for adherence to both company standards, and government/industry regulations (GCP/ICH), standard of care evaluation; trains investigators and travel to clinical sites of necessary to build relationships with investigators and study teams in support of study enrollment.
- Institutes and continuously improves operating procedures ensuring best practices.
- Establishes appropriate strategic partnerships with centers of excellence, advocacy groups and KOLs in the areas of scientific interest.
- Collaborates closely with key stakeholders to ensure tight strategic integration of product development plans and strategies. Plans and develops content for advisory meetings with opinion leaders and medical symposia.
- Participates in review of any promotional and medical materials to ensure content is medically appropriate and compliant with internal and external requirements.
- Stays up-dated regarding relevant therapeutic areas through familiarity with literature, attendance at meetings, conventions, and professional associations.
Sound Biologics offers a team-oriented, stimulating work environment.
We offer challenging career opportunities, competitive benefits and an environment that recognizes and rewards performance.
Sound Biologics is an equal opportunity employer.
Please use the form below to apply directly.