The Director/Senior Director, Clinical Pharmacology is a highly scientific strategic role leading multiple facets of Clinical Pharmacology, including study design, PK and PK/PD analyses, and overall drug development support. This individual will be responsible for developing and implementing the clinical pharmacology strategy for Venatorx’s product portfolio, including design and execution of clinical pharmacology studies, data analysis, internal decision making, and external regulatory interactions.
Duties and responsibilities
Responsibilities include:
- Develop and implement the clinical pharmacology strategy for Venatorx’s product portfolio, including design and execution of clinical pharmacology studies, data analysis, internal decision making, and external regulatory interactions to support marketing approval
- Work closely with cross functional teams, including Nonclinical Safety and Toxicology and Clinical Science, and be the subject matter expert in pharmacology, pharmacokinetics and pharmacodynamics in order to internal decision making
- Provide input and oversight to pharmacokinetic and pharmacodynamic modeling required to support development and approval of antibiotics, including extrapolation into patient subsets
- Lead/supervise the development of bioanalytical methods and qualification, usually in conjunction with external experts and qualified CROs, and the internal team.
- Author components and review overall program strategy, study design, protocol preparation, study execution, data review/analysis, study reports and regulatory document preparation
- Represent clinical pharmacology during meetings and discussions with regulatory authorities
- Maintain a high standard for good laboratory and clinical practices, compliance, and ethical standards
- Support non-clinical pharmacology efforts when appropriate
Qualifications
Candidate requirements:
- PhD in pharmaceutical sciences/pharmacology/related field or MD or PharmD with at least 1 years of relevant clinical pharmacology experience within the pharmaceutical and biotechnology industry
- Prior infectious disease pharmacology clinical development experience preferred
- Prior experience with small molecules is preferred
- Experience filing INDs and supporting NDAs/BLAS required
- Demonstrated experience in writing, presenting, and discussing clinical pharmacology with both internal and external stakeholders, including regulatory authorities
- Strong analytical skills and ability to interpret complex nonclinical and clinical data sets coupled with excellent written and verbal communication skills
- Proven ability to work in cross-functional teams and manage multiple projects, engaging subject matter experts across functions to drive the execution of programs
- Ability to thrive in a fast-paced and evolving company environment
- Proven ability to work with a high level of integrity, accuracy, and attention to detail
- Ability to make thoughtful, integrated, timely and meaningful decisions and take corresponding actions
- Ability to operate autonomously in a fast-paced clinical development company
This is a representative description of the job and is not intended to be all-inclusive. Employee may perform other related duties as required to meet the ongoing needs of the organization. Duties, responsibilities, and activities may change at any time with or without notice.
Venatorx is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, national origin, age, marital status, protected veteran status, disability status, or any other status protected by federal, state, or local law.
For more information, please check out our website: www.venatorx.com
