Pardes Biosciences is a clinical-stage biopharmaceutical company created by and for this moment to help solve pandemic-sized problems, starting with COVID-19. We are applying modern reversible-covalent chemistry as a starting point to discover and develop novel oral drug candidates while reimagining the patient journey to access these medicines. By capitalizing on emerging patient-friendly innovations from telehealth to new at-home diagnostic tools, Pardes is cultivating and harvesting the fruits of systemic change. We believe it is a privilege, and our responsibility, to help stop a pandemic and start a movement. We are on a mission to help patients everywhere get well sooner.
We are a virtual company with hubs in the San Francisco Bay Area, Greater Boston and Greater San Diego. All of our roles are remote at this time. It would be fantastic if candidates are located by our hubs but not a requirement. Candidates must be located in the United States.
Pardes Biosciences is looking for an Executive Director of Clinical Pharmacology to support our fast progressing lead project PBI-0451 and in addition to contributing to non-clinical and clinical programs.
In this role, you will represent the clinical pharmacology discipline on development project team, align and influence across the cross-functional team to support drug development project from early to late phase in clinical development. You will collaborate with discovery and nonclinical development teams, bridging drug discovery and clinical application to advance the scientific knowledge of drug metabolism, pharmacokinetics and clinical pharmacology.
- Lead the development and reporting of clinical pharmacology strategies, PK evaluation and interpretation
- Bridge nonclinical and clinical PK and lead the techniques on PK analysis with optimized models using software to develop clinical pharmacology study protocols and contribute broadly to relevant clinical study protocols
- Drive the impact of PK/PD modeling and simulation to inform dose selection and optimization
- Responsible for authoring regulatory documents and addressing health authority inquiries.
- Manage internal and external resources including consultants and work done at CROs.
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
- PhD/ Pharm.D. in a drug development discipline
- 15+ years of relevant experience in clinical pharmacology and pharmacokinetics and/or DMPK in the pharmaceutical or biotechnology industry.
- Demonstrated experience in leading all clinical pharmacology related aspects in the support of early to late phase clinical drug development
- Experience in authoring clinical pharmacology modules of regulatory submissions and addressing regulatory inquiries.
- Expert knowledge and hands-on experience with PK, PK/PD evaluation and population PK, driving dose exploration and selection
- Proficient with WinNonlin software, conducting PK and PK/PD analysis and modeling.
- Experience in other technical software programs (eg, WinNonmix, Phoenix NLME, NONMEM, Gastroplus, ADAPT2, R, SAS) a strong plus.
- Ability to work in a fast-paced and challenging environment, passion about science
- Ability to think critically and solve problem, self-driven and a strong team player.
Unsolicited resumes sent to Pardes Biosciences from recruiters do not constitute any type of relationship between the recruiter and Pardes Biosciences and do not obligate Pardes Biosciences to pay fees should we hire from those resumes. We ask that external recruiters and/or agencies not contact or present candidates directly to our hiring manager or employees.
Pardes Biosciences is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. We are committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics. We encourage applicants of all ages.