Job DescriptionThe Opportunity: Clinical Pharmacology QC LeadWe are seeking an experienced Temporary Clinical Pharmacology QC Lead to support quality control review of clinical pharmacology submission documents and regulatory responses for oncology programs in late-stage development. This role will ensure scientific accuracy, cross-document consistency and high-quality submission-ready documentation aligned with regulatory expectations and internal standards, supporting timely responses to regulatory agencies.Required Skills, Experience and Education: Advanced degree (MS, Pharm D, Ph.D, MD or equivalent) in life sciences, pharmacy or related field. Strong experience in NDA submissions, Clinical Pharmacology and/or clinical documents. Demonstrated expertise in QC of regulatory documents Strong understanding of ICH guidelines, CTD format and FDA/EMA regulatory processes. Excellent attention to detail and ability to work under tight timelines. Strong cross-functional communication and issue resolution skills.Preferred Skills: Oncology drug development experience Experience supporting FDA information requestsDuration & Commitment: Contract position 6 months+ Remote flexibility possible but candidates will be working onsite at HQ in Redwood CityEqual Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it's from an official Planet Pharma domain (@, @planet-pharma.co.uk, and @) and not a domain with an alternative extension like .net, .org or .jobs.
Job Title
Clinical Pharmacology QC Lead