Associate Director, Clinical Science
Based in San Diego, CA, Escient Pharmaceuticals is a clinical-stage biotech company strategically focused on unleashing the therapeutic potential of Mas-Related G-Protein Receptors (Mrgprs) for a broad range of therapeutic indications. Our diverse team at Escient shares a passion for discovering and developing therapies for unserved patients that will positively change the course of their health and well-being. In addition, we embrace a unique and highly sought-after culture of authenticity, open communication, transparency, integrity, mutual respect, and freedom to brainstorm and share one’s thoughts and ideas at every level.
Escient is seeking a dynamic, creative and highly motivated individual for the position of Associate Director, Clinical Science to translate research concepts/strategies into specific clinical objectives and activities to ensure program success. This position will work with other development team members, external key opinion leaders, patient advocacy organizations, CROs, clinical sites and consultants to ensure the appropriate scientific rigor in the clinical program.
The ideal candidate is forward thinking and creative with high ethical standards with experience interacting with and building strong relationships with key opinion leaders or trial investigators. To be considered, candidates must be able to work in a fast-paced environment with drug development professionals and able to respond to changing priorities in a thoughtful, creative manner.
MAIN RESPONSIBILITIES include the following:
- Development of clinical trial designs and protocol in collaboration with external opinion leaders, internal translational science/clinical/medical team
- Provide input to statistical analysis plans and key contributor to all study related documents (informed consent, study manuals, data management plan, safety management plan, protocol deviation plan, etc.)
- Collaborate with clinical operations, data management, biostatistics, and safety on execution of clinical studies to achieve program goals
- Review and interpret clinical study data and contribute to clinical study reports, abstracts, and manuscripts as required
- Presentation of clinical trial data or other related topics at scientific meetings, advisory board meetings, and internal team meetings
- Contributor to clinical development strategy and regulatory document preparation and review
- Remain up to date with therapeutic area science, competitors, regulatory requirements and guidelines
- Ensure all clinical activities are delivered in accordance with expectations, trial protocol, ICH/GCP guidelines and applicable SOPs and regulations
EDUCATION AND QUALIFICATIONS
- Advanced degree in a scientific discipline: MS, PhD or PharmD preferred with 4+ years of drug development experience
- Must demonstrate knowledge of clinical development process, including clinical trial management and data reviews
- Proficient at working in both remote and office environments
- Team player with strong leadership skills
- Ability to present technical and business aspects of projects
- Strong interpersonal skills with an ability to effectively communicate to people at all levels of an organization, to be able to interact and influence, and build strong positive relationships
- Demonstrated problem solving skills, a strong sense of urgency, keen attention to detail, and the ability to plan, organize and successfully execute in an environment under time and resource pressures. Must be focused and able to meet tight timelines.
- Experience with specialty laboratories to establish new methodology/assay is a plus
- Current knowledge of GCP, ICH guidelines and FDA regulations, as well as familiarity with EMA/CHMP regulations and guidelines, and other international regulatory requirements.
Travel will be required to the extent necessary for scientific, advisory or regulatory meetings, as well as for clinical study execution (anticipated 10-20%).
Escient operates in a hybrid model of working in the office part-time and working remotely from home part-time. This position will initially work remotely on a full-time basis, but it is anticipated that working onsite in the San Diego office for minimally two days per week will resume at some point in 2021. Candidates must be able to report to the San Diego office.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee will regularly be required to use his/her hands and fingers to operate a computer keyboard, mouse, and telephone keypad or to write, as well as talk and hear. The employee will regularly be required to sit, stand, walk, talk and hear; use hands to handle or feel; see computer screens and read printouts; and reach with arms and hands. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and ability to focus.
If you thrive in a fast-paced, entrepreneurial environment and are in search of a dynamic, multi-disciplinary team focused on discovering and developing therapies that will positively change the course of the health and well-being of underserved patients, we encourage you to apply. Escient Pharmaceuticals offers a positive and exciting work environment with competitive pay structures and benefits. Escient is an equal opportunity employer.