Senior Director, Clinical Pharmacology

Beeline Medicines; Boston; Hybrid; PHP 16,667,000 - 21,554,000; Full time

Benefits offered by this job

Hybrid work schedule

Job summary

Beeline Medicines seeks a Senior Director, Clinical Pharmacology to lead PK/PD strategy across development programs, directing modeling, dose-selection, and regulatory submissions. The role requires leadership of cross-functional teams and oversight of external CROs.

You will drive population PK/PD analyses, author regulatory sections, and coordinate with health authorities. A hybrid work arrangement is available with global teams and ongoing strategic initiatives.

Qualifications

• 10+ years of clinical pharmacology experience in pharma/biotech.
• 3+ years of vendor management oversight with CROs.
• Experience in immunology or immune-mediated diseases preferred.
• Expertise in population PK/PD modeling and relevant software.
• Strong knowledge of ICH and FDA/EMA guidance.
• Proven ability to lead clinical pharmacology strategy discussions with regulators.
• Excellent scientific writing and presentation skills.
• Ability to manage external CROs/vendors and cross-functional teams.

Responsibilities

• Lead clinical pharmacology strategy for programs and dose-selection.
• Direct population PK and modeling analyses.
• Author clinical pharmacology sections of INDs, NDAs/BLAs, and responses.
• Represent clinical pharmacology in interactions with health authorities.
• Oversee CRO and vendor relationships and deliverables.
• Provide clinical pharmacology assessments to due diligence and licensing.
• Coordinate study execution across multiple stakeholders.
• Contribute to cross-functional program team leadership.

Skills

Clinical pharmacology leadership

PK/PD modeling

Vendor management

Regulatory strategy

Cross-functional leadership

Excellent scientific writing

Education

PharmD

PhD in Clinical Pharmacology/Pharmacometrics

Tools

NONMEM

R

Job description

About Beeline Medicines:

Beeline Medicines is a clinical-stage biotechnology company focused on developing and delivering category-leading precision therapies to transform the lives of people living with autoimmune and inflammatory diseases. With a portfolio of potential best-in-class and first-in-disease therapeutic candidates that directly target key pathways governing dysregulated immunological and inflammatory responses, the Company is developing medicines that have the opportunity to provide durable, life-changing impact. Led by an established executive team and backed by world-class life science investors, each day Beeline Medicines is determined to bring the scientific rigor and operational excellence to get to what matters for patients - realizing a world where people with immune-mediated diseases can live life fully.

Job Summary:

The Senior Director, Clinical Pharmacology provides clinical pharmacology leadership across development programs, directing PK/PD strategy, modeling and simulation, and dose-selection activities to inform clinical trial design and regulatory submissions. Leads population PK, exposure-response, and other quantitative modeling efforts performed internally or through modeling vendors and translates the resulting insights into dose-selection rationale that shapes protocol design. Serves as the clinical pharmacology voice on cross-functional program teams and represents the function directly with health authorities during meetings and submission reviews. This role requires both technical modeling expertise and the credibility to defend clinical pharmacology strategy in high-stakes regulatory interactions.

Work Arrangement & Location:

Hybrid - This position follows a hybrid work schedule, requiring a minimum of two (2) days on-site per week - currently designated as Tuesday and Wednesday. Additional on-site days may be required based on business needs, team priorities, or leadership direction.

Essential Duties and Responsibilities:

• Lead clinical pharmacology strategy for assigned programs, including PK/PD study design and dose-selection rationale.
• Direct population PK, exposure-response, and modeling and simulation analyses performed internally or by vendors.
• Author and review clinical pharmacology sections of INDs, NDAs/BLAs, and health authority responses.
• Serve as clinical pharmacology lead on cross-functional program teams, advising on drug-drug interaction and special population studies.
• Represent clinical pharmacology in interactions with health authorities (e.g., FDA/CHMP meetings), including authorship of relevant sections of briefing documents.
• Provide clinical pharmacology assessments to due diligence and licensing evaluations, as applicable.
• Oversee clinical pharmacology CRO and modeling vendor relationships and deliverables.
• Perform other duties and responsibilities as assigned

Qualifications:

• Education: PharmD, PhD in Clinical Pharmacology, Pharmacokinetics, Pharmacometrics, pharmaceutical sicences, or related discipline required.
• 10+ years of clinical pharmacology experience in pharma/biotech, including leadership of PK/PD strategy across development-stage programs.
• 3+ years of vendor management oversight experience with ability to manage and hold CRO/modeling vendors accountable for deliverable quality.
• Experience in immunology, inflammation, autoimmune disease, immune-mediated diseases, T-cell biology, cell therapy, biologics, gene therapy, or other novel therapeutic modalities preferred
• Expertise in population PK/PD modeling, , and relevant software (e.g., NONMEM, R).
• Strong knowledge of ICH and FDA/EMA clinical pharmacology guidance.
• Understanding of drug-drug interaction and special population study design.
• Proven ability to lead clinical pharmacology strategy discussions with senior internal and external stakeholders, including regulators.
• Excellent scientific writing and presentation skills for regulatory submissions and health authority interactions.
• Skilled at defending clinical pharmacology strategy directly with health authorities.
• Demonstrated ability to manage external CROs/vendors and coordinate study execution across multiple stakeholders
• Strong project/program management capability, including timeline planning, cross-functional coordination, risk tracking, deliverable management, and issue escalation.
• Ability to communicate scientific and operational issues clearly to cross-functional teams and senior stakeholders.

Salary Range:

The expected salary range for this position varies by location and will be communicated based on the country or region in which the selected candidate is hired. Actual pay will be determined based on experience, qualifications, location, and other job-related factors permitted by applicable local law. A discretionary annual bonus and long-term incentive award (e.g., equity) may be available based on individual and Company performance.

$266,000 - $344,000 USD

Benefits:

We offer a comprehensive benefits package tailored to the country and region in which you are hired, in compliance with local laws and practices. Benefits may include, but are not limited to:

• Competitive health and wellness coverage (structure and premiums vary by country)
• Paid time off, public holidays, and additional leave entitlements in accordance with local requirements
• Flexible work arrangements / hybrid schedule

Benefits vary by location and are subject to eligibility requirements, local regulations, and plan terms. Specific benefit details applicable to your country or region will be provided during the offer process.

Equal Employment Opportunity:

Beeline Medicines is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, disability, age, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.

Reasonable Accommodation:

If you require a reasonable accommodation to participate in the application or interview process, please contact [e-mail] to request an accommodation. We are committed to providing equal access to all candidates.

Privacy

Upon submission of this form I understand that Beeline Medicines is based in the United States and personal data submitted in the form will be transferred and accessed in the U.S., Information about Beeline Medicines privacy practices can be found at Privacy Policy - Beeline Medicines