Category: Scientific & Clinical
Title: Director, Clinical Pharmacology (Neuroscience)
Location: Woodcliff Lake, NJ
Start date: ASAP
- Lead Translational Science research through designing and executing Clinical Pharmacology activities in the development of innovative drugs in the neuroscience portfolio.
- Provide direction, planning and execution of the Clinical Pharmacology programs integrating novel translational biomarkers and quantitative modeling/simulation in the clinical development programs.
- Active contributor to the cross-functional teams, providing innovative and progressive thinking to projects and where appropriate provide guidance to other team members.
- Act independently, within a matrixed clinical development organization and must have the experience and conviction to provide sound input to various project teams with regard to clinical pharmacology, translational and quantitative activities.
- Driving the development and execution of the Clinical Pharmacology strategy for small and large molecules in drug development and delivering key components of the Clinical Development Plan.
- Providing scientific leadership on Clinical Pharmacology strategy and translational science to cross-functional project teams. Working with clinical development and/or program teams to achieve program goals and provide deliverables in approved timeframes.
- Designing and implementing Clinical Pharmacology studies that allow early go/no-go decisions, incorporate innovative clinical development strategies and support competitive drug labels. Leading the integration of modeling & simulation (PK/PD) and PGx activities in the Clinical Pharmacology programs.
- Serving as a Study Director/Clinical Pharmacology lead and driving the execution of the protocol concept to final report including interpretation of clinical data.
- Creating and maintaining internal and external networks to maintain cutting edge knowledge of Clinical Pharmacology approaches and to implement novel designs in the clinical trial.
- Representing and leading clinical pharmacology contributions to all regulatory documents including Investigator Brochures, EOP2 meetings, Type C, NDA meetings. Leading the resolution of clinical pharmacology queries from drug regulatory agencies and taking a lead role in writing and reviewing responses to regulatory queries.
- Providing recommendations for clinical doses and dosing algorithms (including drug interaction advice, food effects, special group dosing etc.) to the clinical and project teams and in regulatory documentation
- Maintaining extensive scientific awareness and presence in Clinical Pharmacology, Publishing multiple manuscripts and posters, and Presenting at Scientific Conferences and other scientific forums.
- MD or PhD in Clinical Pharmacology, Pharmacokinetics, Pharmacometrics, or other related field.
7-10 years of experience in pharmaceutical or biotechnology industry with a broad and proven understanding of drug development.
Experience interacting with regulatory agencies including being directly involved in the review process.
- Must have been directly involved with successful major regulatory filings.
- Expertise in providing CRO and consultant oversight.
- Experience in neuroscience and translational science is not required but strongly preferred.
- Experience internal medicine, pediatric indications is also preferred.
- Must be self-motivated, able to work in cross-functional global teams and have a strong work ethic and integrity.
- Must possess outstanding verbal and written communication skills and be able to build relationships and influence decision-making, while managing tight-timelines.
Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.