Senior Scientist, Pharmaceutical Development

About TrialSpark

TrialSpark is a technology-driven drug development company that runs end-to-end clinical trials, focused on bringing new treatments to patients faster and more efficiently.

TrialSpark recently raised their Series C, and is putting the capital to work by  in-licensing and co-developing drug programs through in-house development, joint ventures, and NewCos. Together with doctors, patients, and communities, TrialSpark is working to develop the treatments of tomorrow.

The biggest bottleneck in bringing new treatments to patients is the clinical trial. On average, getting a drug through the registrational trials may take nearly a decade and frequently costs $1B+. To address  this industry problem, TrialSpark has built a technology platform that optimizes all aspects of a clinical trial, enabling more efficient trial design, faster trial completion, and higher trial data quality.  Along with the focus on clinical trials, we are building an R&D team develop the licensed products and look for additional ways to make the drug development process faster and more efficient.

Responsibilities

• Manage and coordinate CMC activities and document flow for assigned development projects via interface with external Contract Research Organizations (CROs) and Contract Manufacturing
• Organizations (CMOs), to include:
• Formulation development activities of solid oral dosage forms and/or topical dosage forms
• Drug product manufacture
• Stability studies associated with API and drug product
• Contribute to the evaluation and selection of CMOs for drug product manufacturing, packaging and labeling of solid oral and topical dosage forms
• Ensure adherence of CMOs to current Good Manufacturing Practices (cGMP)
• Manage clinical drug supplies via interface with drug storage and distribution and clinical CROs
• Track drug substance and drug product supplies on an ongoing basis and ensure timely re-supply when needed
• Ensure appropriate project management and oversight for multiple CMOs and CROs
• Participate in on-site audits of CROs and CMOs as needed
• Prepare drug substance and drug product documents for regulatory filings (IND applications, amendments and annual reports), and ensure regulatory compliance
• Contribute to preparation of CMC budgets
• Contribute to preparation of patent applications as needed
• Contribute to and participate in program reviews, licensing and related activities

About You 

• B.S. or M.S. in Pharmaceutical Sciences, Chemical Engineering, or related physical or life science with 5-10 years of experience in the pharmaceutical or biotechnology industry
• Experience managing activities related to drug product manufacturing at multiple external CMOs
• Basic understanding of cGMP regulations, ICH and other regulatory documents as they relate to the manufacture of drug product
• Specialized Knowledge and Skills
• Excellent organizational skills and solid project management skills required to apply to multiple projects and extensive interactions with multiple CROs, CMOs and consultants
• Ability to prioritize and manage multiple tasks in parallel
• Ability to manage information and data, with attention to detail
• Ability to interpret and communicate scientific data to internal/external colleagues, written and verbally
• Ability to work independently and as a member of an interdisciplinary team
• Ability to deal with ambiguity, and make timely and quality decisions to achieve goals
• Effective problem-solving skills and judgment
• Strong technical writing skills