What are the responsibilities and job description for the Sr. Director, Quantitative Clinical Pharmacology & Bioanalysis, Oncology-ID1508 position at Ascendis Pharma A/S?
Ascendis Pharma is a dynamic, fast-growing global biopharmaceutical company with locations in Denmark, Europe, and the United States. Today, we're advancing programs in Endocrinology Rare Disease and Oncology.
Here at Ascendis, we pride ourselves on exceptional science, visionary leadership, and skilled and passionate colleagues.
Guided by our core values of Patients, Science, and Passion, we use our TransCon drug development platform to fulfill our mission of developing new and potentially best-in-class therapies to address unmet medical needs.
Our culture fosters a place where skilled, adaptable, and highly resourceful professionals can truly make their mark. We offer a dynamic workplace for employees to grow and develop their skills.
The Sr. Director, Quantitative Clinical Pharmacology & Bioanalysis, Oncology will provide functional leadership, oversight, and expertise in support of the clinical development activities. This individual will collaborate closely with the cross-functional teams on protocol development, be responsible for data analysis and interpretation of results, and work closely with Biomarkers, Data Management and Statistical Programming resources to achieve deliverables and activities with CROs / vendors. Additional analysis support of non-clinical / biomarker / CMC data and providing insight to contribute to Ascendis’ scientific research may be requested. The role reports to EVP, Clinical Development Oncology.
Key Responsibilities
- Formulate and deliver Quantitative Clinical Pharmacology and Bioanalytical strategy for all oncology clinical development assets.
- Apply pharmacokinetic / pharmacodynamics (PK / PD), physiologic based PK (PBPK) and pharmacometric modeling & simulation (M&S) approaches to characterize drug disposition and assess the dynamics of drug effect to inform dosage selection, drug combinations, and go / no-go decisions.
- Work with clinical, translational, company scientists, and CROs to support ongoing oncology studies to ensure timely conversion of data to knowledge, publication strategy, aligned with programmatic deliverables.
- Contribute and drive quantitative strategy, study design, protocol preparation, amendments, data analysis, report preparation and regulatory document and health authority responses.
- Manage, supervise and provide guidance for the Oncology Biomarkers function.
Knowledge, Skills and Experience
Education / Training
Salary range : $220-250K / year
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Salary : $220,000 - $250,000
