- Job Type: Full-Time
- Function: Clinical Research
- Industry: Biotechnology
- Post Date: 02/06/2023
- Website: www.escientpharma.com
- Company Address: 10578 Science Center Drive, Suite 250, San Diego, CA, 92121
- Salary Range: $150,000 - $180,000
About Escient PharmaceuticalsEscient Pharmaceuticals is a provider of bio-technical research and development services intended to focus in advancement of first-in-class G Protein-Coupled Receptor targeted drugs. The company's services focuses on offering therapies for neuro-immuno-inflammatory and autoreactive diseases, enabling its clients to receive drugs required fortreatment of serious, unserved medical needs across a broad range of therapeutic indications.
Escient Pharmaceuticals is a San Diego based clinical-stage company focused on developing novel therapeutics to address a broad range of neurosensory-inflammatory disorders. The company’s pipeline includes two first-in-class small molecule antagonists targeting MRGPRX2 for the treatment of various mast cell mediated disorders and MRGPRX4 for cholestatic pruritus. Escient is led by an experienced management and scientific team and funded by top-tier life science investors.
Our team is driven by the desire to make a positive difference in the lives of patients. We are passionate about innovative science and strive to discover and develop novel medicines, to bring value to the healthcare ecosystem, and to address significant unmet medical needs. We foster a culture of innovation, collaboration, transparency, mutual respect, and integrity and an environment where employees feel fulfilled by the work they do and are recognized for the contributions they make.
Escient is seeking a dynamic, creative and highly motivated individual for the position of Associate Director, Clinical Supplies to design, develop, and implement the clinical supplies strategy to ensure appropriate processes are established and clinical supplies deliverables are met for clinical trials. This individual will also manage clinical supply activities including planning and forecasting of clinical supply, oversight of clinical packaging, labeling, distribution operations, and inventory management at contracted clinical supplies vendors. Responsibilities include forecasting and tracking budget, developing supply strategies, and implementing systems associated with supply management such as IRT. This individual will partner with other functional leaders in CMC, Regulatory Affairs, Clinical Operations, and Quality to ensure timely supply delivery to support clinical trials in compliance with regulatory requirements.
The ideal candidate must be able to work in a fast-paced environment with drug development professionals and be able to respond to changing priorities in a thoughtful, creative manner.
Candidates must have the ability to report to the San Diego corporate office periodically. Travel will be required to the extent necessary for oversight of vendors (anticipated 5-10%).
Primary responsibilities include:
- Create and manage clinical forecast plans and budgets related to drug product and clinical supplies for multiple programs and studies in line with study protocols and clinical development plans
- Create global supply strategies, supply plans to support clinical studies
- Collaborate with cross functional departments and vendors to execute the strategies for the clinical studies
- Manage clinical trial supply to ensure timely clinical supplies delivery
- Manage inventory, expiry date extensions, and distribution activities to ensure uninterrupted supply
- Lead the development, testing, and implementation of IRT systems
- Work with Clinical Operations on the development of drug supply related documents and manuals to ensure compliance with protocol and regulatory requirements
- Participate in clinical study meetings as the Clinical Supplies representative and help to facilitate communications between Clinical Operations, CMC and QA to ensure timely delivery of supplies
EDUCATION AND QUALIFICATIONS
- BS/BA degree in related discipline and a minimum of 10 years of related experience or equivalent combination of education and experience
- Experience in independently leading all aspects of clinical supplies management for trials from phase 1 to phase 3 including global trials
- Experience in leading implementation of IRT systems
- Strong initiative and desire to work in a fast-paced team-oriented, and dynamic environment
- Creativity and flexibility in problem solving
- Ability to work collaboratively as part of a team
- Knowledge of GMP batch record development, review, and approval processes
- Working knowledge of regulations relating to clinical labeling, packaging and distribution activities
- Working knowledge of GMP/GCP/GLP/GDP regulations
- Excellent oral and written communication skills along with strong demonstrated stakeholder management skills
- Excellent project management and organizational skills
- Ability to plan and execute multiple on-going projects with ease
- Networks with key contacts outside own area of expertise
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.
Escient Pharmaceuticals, Inc.’s Human Resources team manages its own recruitment and employment process. To protect the interest of all parties involved, Escient will only accept resumes from a recruiter if an executed search agreement is in place at the start of the recruitment effort for a particular open position. Unsolicited resumes sent to Escient from recruiters do not constitute or create any type of relationship between the recruiter and Escient, and Escient shall not pay any fees should we hire any individual from those resumes. Recruiters are requested not to contact or present candidates directly to Escient’s hiring manager or employees.