Clinical Pharmacology Consultant
171 Oyster Point Blvd South San Francisco, CA 94080 | Contract-to-Hire
Bayside Solutions is seeking a highly motivated, Clinical Pharmacology Consultant to be a part of our partner’ s team in the South San Francisco Area. This is a unique opportunity to join a growing company dedicated to developing novel therapeutics to treat undertreated blood-based disorders.
Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website at www.baysidesolutions.com.
Clinical Pharmacology Consultant:
This individual supports the Clinical Pharmacology representative on development teams and provides clinical pharmacology expertise to development projects. The individual will have proficiency in the use of innovative analytical methods to integrate knowledge of pharmacokinetics, biopharmaceutics, pharmacodynamics, 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, commercial viability and fulfillment of registration requirements. He/she will be an individual contributor on projects.
- Work for a company that is local to the bay area and recognized as a leader of innovation.
- Competitive compensation commensurate with experience.
- This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.
Summary of Responsibilities:
- Represent Clinical Pharmacology on development project teams.
- Partner in the development of clinical pharmacology strategies and the execution of clinical pharmacology studies and exposure-response & population PK/PD analyses.
- Contribute to the development of clinical study concepts and protocols, clinical study reports, and relevant components of regulatory submission documents.
- Review non-clinical as well as clinical pharmacology development plans.
- Assist in the interpretation of preclinical data and extrapolation of implications for human clinical development.
- Responsibility for submitting Clinical Pharmacology sections for review to the Sr. Director, Clinical Pharmacology for regulatory documents.
- Writes support documents for review by Sr. Director, Clinical Pharmacology for responses to regulatory agencies.
- An advanced degree (PhD, or PharmD) in pharmacology, pharmaceutical sciences, pharmacy, life sciences, or other related fields.
- A minimum of 6-10 years relevant experience in the biotech/pharmaceutical industry; minimum of 4 years in small molecule clinical pharmacology experience.
- Experience with conducting and analyzing clinical pharmacology/pharmacokinetic studies in humans.
- In-depth understanding of PK/PD, drug metabolism and clinical research concepts.
- Strong theoretical background and hands-on experience interpreting clinical dose-response and PK/PD data to inform clinical study designs and drug development decision-making.
- Proficiency with WinNonlin, or other modeling software.
- Knowledge of regulatory guidance related to clinical pharmacology.
- Excellent oral and written communication skills and a proven track record of working effectively in a dynamic, collaborative, team-oriented setting.
- Ability to thrive in a fast-paced, entrepreneurial environment with high performing colleagues.
- Ability to build strong relationships with co-workers of various backgrounds and expertise.
- Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor.