Director, Clinical Pharmacology Lead

This is a fully remote position, open to applicants in United States.

📋 Description

• Provide strategic direction for Clinical Pharmacology initiatives within the West Coast Hub Transplant portfolio.

• Lead Clinical Pharmacology efforts that support BLA submissions, regulatory interactions, labeling strategies, and lifecycle management.

• Represent Clinical Pharmacology in program and study teams as well as governance forums.

• Develop and implement comprehensive Clinical Pharmacology strategies that support dose selection and justification, benefit-risk evaluations, regulatory approvals, and lifecycle management.

• Oversee the preparation of Clinical Pharmacology sections for BLAs, supplemental filings, briefing materials, information requests, and regulatory responses.

• Provide strategic leadership during regulatory interactions and represent Clinical Pharmacology in discussions with health authorities.

• Propel Clinical Pharmacology contributions to filing readiness while identifying and mitigating regulatory risks.

• Lead and supervise exposure-response assessments, population PK analyses, evaluations of intrinsic and extrinsic factors, immunogenicity impact assessments, and Model-Informed Drug Development methodologies.

• Collaborate with Pharmacometrics and other quantitative functions to align analyses with regulatory and developmental goals.

• Offer mentorship and technical guidance within Clinical Pharmacology, enhancing Clinical Pharmacology capabilities across WCH Development.

• Stay updated on advancements in Clinical Pharmacology science, regulatory expectations, and development precedents relevant to transplant and immunology programs.

⛳️ Requirements

• PhD, PharmD, MD, or MD/PhD in Pharmacology, Pharmacokinetics, Pharmaceutics, Clinical Pharmacology, or a related field.

• Over 8 years of pertinent industry experience, particularly in late-stage development, regulatory submissions, and interactions with health authorities.

• Proven experience as a Clinical Pharmacology Lead for development programs, responsible for strategy and execution.

• Established record of authoring and defending Clinical Pharmacology sections in BLAs, NDAs, supplemental applications, or comparable regulatory submissions.

• Experience in leading Clinical Pharmacology strategies for registration-enabling programs and facilitating regulatory agency interactions.

• Extensive expertise in dose justification, exposure-response evaluation, immunogenicity assessments, and Model-Informed Drug Development methodologies.

• Strong understanding of Clinical Pharmacology regulatory guidance and expectations for biologic products.

• Experience in transplant, nephrology, immunology, or related therapeutic areas.

• Ability to influence cross-functional teams and drive strategic decisions within a matrix environment.

• Exceptional written, verbal, presentation, and interpersonal communication skills.

🏝️ Benefits

• Medical, Dental, Vision, & Life insurances.

• Fitness & Wellness programs, including fitness reimbursement.

• Short- and Long-Term Disability insurance.

• A minimum of 15 days of paid vacation plus additional time off during the year-end shutdown (Dec 26-Dec 31).

• Up to 12 company-paid holidays and 3 paid days off for Personal Significance.

• 80 hours of sick leave per calendar year.

• Paid Maternity and Parental Leave benefits.

• Participation in a 401(k) program with company-matched contributions.

• Employee stock purchase plan.

• Tuition reimbursement of up to $10,000 per calendar year.

• Participation in Employee Resource Groups.

• Short-term and long-term incentives, including cash bonuses and equity incentive opportunities.