True Title: Clinical Pharmacologist (Director, Clinical Pharmacology)
6-Month Initial Contract
Remote | EST hours
This role will play a pivotal part in supporting the late-stage clinical development of biologics in the fields of immunology, neurology, and hematology. The ideal candidate will bring deep expertise in pharmacokinetics (PK) and pharmacodynamics (PD) to contribute to regulatory submissions (IND, BLA), clinical study reports (CSR), and related activities. Will support Multiple TA's- immunology, neurology and hematology. If you have a passion for drug development, regulatory science, and biologics, we'd love to hear from you!
MUST HAVE
- PhD (Pharmaceutics, Pharmaceutical Chemistry or Clinical Pharmacology preferred)
- Late clinical development Phase, biologics experience required
- No hands on modeling work, but must have direct experience to understand model-informed drug development
- IND and BLA experience
- EST based due to early meetings with EU colleagues
location: Telecommute
job type: Contract
salary: $200.00 - 289.05 per hour
work hours: 9 to 5
education: Doctorate
responsibilities:
- Act as the Clinical Pharmacology Lead on early- to late-stage programs to set clinical development plans.
- Support PK/PD aspects of clinical studies, including synopsis/protocol development, statistical analysis plan and clinical pharmacology data analysis plan review, TLF shell and dry-run reviews, and CSR.
- Oversee relevant PK/PD data analyses: non-compartmental PK, population PK and PK/PD, and other modeling and simulation activities as needed.
- Contribute to regulatory documents including Investigator Brochures, Labeling and those required for regulatory meetings and regulatory filings.
qualifications:
Required
- A Ph.D. or equivalent degree in clinical pharmacology, biopharmaceutics, pharmaceutical sciences, biomedical engineering, statistics or a related field.
- At least 12 years of full-time experience in a clinical pharmacology role within the pharmaceutical or biotechnology industry. Candidates with substantial expertise working directly in industry settings, rather than consulting or contracting roles, are preferred.
- A minimum of 8 years of direct experience working on large molecule therapeutic modalities or biologics.
- Demonstrated success in leading NDA and/or BLA submissions, showcasing a strong track record of regulatory accomplishments.
- Exceptional verbal and written communication skills, combined with keen attention to detail and organizational proficiency.
skills: Pharmacology
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
This posting is open for thirty (30) days.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
