Head of Quantitative Clinical Pharmacology & Bioanalysis, Oncology-Job ID: 1508 - Ascendis Pharma

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 Head of 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

1. Formulate and deliver Quantitative Clinical Pharmacology and Bioanalytical strategy for all oncology clinical development assets.
2. 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.
3. 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.
4. Contribute and drive quantitative strategy, study design, protocol preparation, amendments, data analysis, report preparation and regulatory document and health authority responses.
5. Manage, supervise and provide guidance for the Oncology Biomarkers function.

Knowledge, Skills and Experience

1. Excellent written and oral communication, interpersonal and problem-solving skills.
2. Experience in oncology drug development with clinical pharmacology strategy is essential; translational and pharmaceutical delivery aspects of drug development are strongly preferred.
3. Ability to deliver integrated clinical pharmacology and bioanalytical roadmap to registration and new product label.
4. Can manage multiple projects under tight timelines working both independently and collaboratively.
5. Experience interacting with global health authorities on optimal dosage/combination in oncology clinical pharmacology is critical.
6. Effective forms of written and spoken communication are essential (e.g., clinical pharmacology protocols, pharmacokinetic/pharmacometric reports and regulatory submissions and performing quality control).
7. Knowledge of regulatory requirements governing drug development including opportunities to utilize MIDD.
8. Resourcefulness, pragmatism, creativity and an independent work ethic.

Education/ Training

1. PhD or PharmD with 15+ years' experience as a Clinical Pharmacologist/Pharmacometrician in the pharmaceutical industry or related field/experience.
2. Extensive experience in building a department from scratch, quantitative pharmacology analyses and pharmacometric modeling and simulation oversight.
3. Knowledge of datacloud infrastructure, R, R-shiny, MATLAB, NONMEM, PBPK (gastroplus or Simcyp or open source) or similar modeling software and substantial experience integrating quantitative clinical pharmacology into oncology drug development strategy.
4. Knowledge and application of the principles of precision medicine as it relates to dose, schedule and combination strategy in cancer immunology is essential.

Salary range: $220-250K/year

A note to recruiters: We do not allow external search party solicitation. Presentation of candidates without written permission from the Ascendis Pharma Inc Human Resources team (specifically from: Talent Acquisition Partner or Human Resources Director) is not allowed. If this occurs your ownership of these candidates will not be acknowledged.

Benefits include:

• 401(k) plan with company match
• Medical, dental, and vision plans
• Company-offered Life and Accidental Death & Dismemberment (AD&D) insurance
• Company-provided short and long-term disability benefits
• Unique offerings of Pet Insurance and Legal Insurance
• Employee Assistance Program
• Employee Discounts
• Professional Development
• Health Saving Account (HSA)
• Flexible Spending Accounts
• Various incentive compensation plans
• Accident, Critical Illness, and Hospital Indemnity Insurance
• Mental Health resources
• Paid leave benefits for new parents