Sr. Clinical Pharmacology Lead (10 years Exp.) - BB9300

Job Description

Sr. Clinical Pharmacology Lead (10+ years Exp.) – BB9300

Location: Remote

Duration: 6+ Months

Updated: 3/31/2025

Max Bill Rate: 450/hr

This contractor will serve as a backup to the internal FTE on projects. This individual will support the PK/PD aspects of clinical studies (from protocol to CSR) and related regulatory submission activities. This role requires a strong pharmacokinetics/pharmacodynamics/pharmacometrics knowledge.

Work Environment: HYBRID (Kendall Square, Cambridge, MA) or REMOTE

Job Responsibilities:

1. Act as the Clinical Pharmacology Lead on early- to late-stage programs to set clinical development plans.
2. 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.
3. Oversee relevant PK/PD data analyses: non-compartmental PK, population PK and PK/PD, and other modeling and simulation activities as needed.
4. Contribute to regulatory documents including Investigator Brochures, Labeling and those required for regulatory meetings and regulatory filings.

Qualifications:

Minimum Education Requirement:

- A Ph.D. or equivalent degree in clinical pharmacology, biopharmaceutics, pharmaceutical sciences, biomedical engineering, statistics or a related field.

Required Experience and Skills:

1. At least 10 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.
2. A minimum of 8 years of direct experience working on large molecule therapeutic modalities or biologics.
3. Demonstrated success in leading NDA and/or BLA submissions, showcasing a strong track record of regulatory accomplishments.
4. Exceptional verbal and written communication skills, combined with keen attention to detail and organizational proficiency.

TechData is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.