Roivants mission is to systematically reduce the time, cost, & risk of delivering new medicines to market by accelerating the development of promising drug candidates to improve the lives of patients & their families. The company is privately held, has in-licensed 25+ assets, & is very well-capitalized. The Roivant R&D team works hand in hand with Business Development & the EVP, Head of R&D & Chief Medical Offer to establish the scientific rationale & initial development strategy for novel drug candidates & in-licensing opportunities.
The Head of Clinical Pharmacology will provide direction, planning & execution of the Clinical Pharmacology programs, with a range of responsibilities within the Clinical Development functional area. This individual will collaborate with medical directors, clinical scientists, biostatisticians, translational scientists, researchers, toxicologists & bioassay specialists to support projects across the Roivant portfolio. The primary focus of this role is to oversee the development of clinical pharmacology programs from early research, through non-clinical development & into clinical development including leading novel assay development, sample management/tracking & data analysis & reporting.
- Drive the development & execution of the Clinical Pharmacology strategy for molecules in drug development & deliver key components of the Clinical Development Plan.
- As clinical pharmacology lead, drive the execution of protocol concepts to final report including interpretation of clinical data.
- Conduct PK, PK/PD & immunogenicity complex data analyses; interpreting & reporting results
- As a key member of the development team, support clinical trial operations & execution through authoring of analysis plans, appropriate sections of clinical protocols, ICFs, IBs, DSURs etc.
- Provide strategic direction to the writing & review of clinical protocols, clinical study reports & Clinical Pharmacology documents, meeting background packages, & other documents submitted to regulatory authorities.
- Maintain extensive scientific awareness & presence in Clinical Pharmacology, Publishing multiple manuscripts & posters, & Presenting at Scientific Conferences & other scientific forums.
- Interact with regulatory agencies & advisory committees as appropriate.
Skills, Qualifications, & Requirements:
- PhD or PharmD with training in clinical pharmacology.
- 10+ years hands on experience in the application of clinical pharmacology within the context of drug development in a corporate setting.
- Prior experience in managing direct reports.
- Expert knowledge in pharmacokinetics, immunogenicity, drug-drug interactions, bioavailability/bioequivalence, special populations, QTc assessment & dose selection.
- Prior experience with biologics is preferred
- Knowledge of current practices, regulatory requirements & issues in bioanalytics, biopharmaceutics, pharmacology, & toxicology
- Excellent written & oral communication skills
- Proven ability to manage multiple projects/tasks at one time