[Cambridge, MA] Head of Clinical Pharmacology
BIORCHESTRA is an innovative biotech company focusing on research and development of ribonucleic acid (RNA) based therapeutics. Our goal is to change the therapeutic paradigm from treating the symptoms to providing fundamental cure of diseases. As we are making steady progress towards selecting our lead clinical candidate, we are therefore looking for an exceptional candidate Clinical Pharmacology to collaborate closely with our early development teams and lead our early human studies.
Based in Daejeon, South Korea, and Cambridge, MA, BIORCHESTRA has identified a novel pathway of neuroinflammation that is involved in neurodegenerative diseases, and has developed proprietary drugs and targeting formulations that allow delivery to the brain through systemic administration.
Head of Clinical Pharmacology (and Biostatistics)
This position will be based in Cambridge, MA, and will report to the Chief Medical Officer of the company.
The successful candidate will have senior-level experience in Human Pharmacology and Drug Development and will have experience in the translational phase of development pharmacology from nonclinical to clinical.
The candidate will have advanced skills in the use of innovative analytical methods to integrate knowledge of pharmacokinetics (PK), biopharmaceutics, pharmacodynamics (PD), patient characteristics and disease states to optimize doses, dosage regimens and study designs, and will work closely with the project team to create clinical development plans that include assessments of a drug’s efficacy, safety, and to optimize clinical utility and commercial viability.
The candidate will have experience in working in team, leading teams, and achieving success through external collaborations and outsourcing.
- Provides expert scientific and strategic Clinical Pharmacology consultation to Clinical/Translational Development, Preclinical Development, Clinical Sciences, Regulatory Affairs, and all levels of management on critical decisions, data analyses, and development plans for multiple projects across multiple development stages
- Leads strategic planning and execution of clinical pharmacokinetic investigations throughout different phases of the clinical development of a therapeutic molecule, and consultation to preclinical teams pertaining to such programs
- Develops bioanalytical methods, develop immunogenicity assessment strategy, facilitate testing, and conduct immunogenicity impact analysis on pharmacokinetics, as well as on safety and efficacy in collaboration with Clinical Development (and Biometrics)
- Strategic planning and application of mathematical modeling and simulation to various stages of drug development to decision making
- Assures alignment across development programs and with strategic objectives
- Authoring and contributing to relevant regulatory documents (IND, protocols, study reports, briefing documents, etc.)
- Provides timeline, budget and resources estimate for program planning
Job Requirements include:
- PhD, or PharmD Ph.D. in a Pharmaceutical Science, Pharmacokinetics, Pharmacology or related field such as Bioengineering
- 10+ years of experience in Clinical and Nonclinical Pharmacology in pharmaceutical/biotech industry, contract research organization (CRO), or academic medical center
- Experience of PK and Clinical Pharmacology of CNS-active or oligonucleotide drugs is preferred
- Experience in Regulatory filings and Regulatory Agency interaction is highly valued
- Leadership of teams, drug development programs, and outsourcing activities is required
- Recognized leadership in complex scientific analyses, business-related procedures, and leadership of multiple projects is highly valued
- Requires broad-based experience in collaborating across multiple functions and company management
- Ability to work across cultures, time zones and languages
- A focus on quality management
- Excellent writing and verbal communication skills, fluent in English
BIORCHESTRA is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.
Please submit your CV and Resume to email@example.com