The Director, Clinical Pharmacology delivers for patients by providing scientific, strategic, and operational leadership in clinical pharmacology and pharmacometrics across SMPA research and development programs. This role thinks future and acts now to ensure that high-quality clinical pharmacology studies and quantitative analyses inform development and regulatory decisions across the product lifecycle, while acting with integrity and upholding the highest scientific, ethical, and compliance standards. Provide clinical pharmacology support to the Translational Medicine and Early Development (TMED) function.

Essential Functions Required for Job

• Integrate the clinical pharmacology strategy within overall clinical development plans, ensuring scientific rigor, patient safety, and compliance with global regulatory expectations (e.g., ICH, FDA, EMA, PMDA etc.).
• Work with cross-functional development teams to align assumptions, resolve issues, and enable timely decisions using clinical pharmacology and quantitative evidence.
• Lead Phase 1 and special population clinical pharmacology studies (e.g., FIH, SAD, MAD, DDI, organ impairments, elderly/pediatric, PET/EEG), including protocol input, operational oversight, and interpretation and communication of results.
• Provide support to the TMED function, including early development strategy, study design, and quantitative interpretation to inform program decisions.
• Drive PK, PK/PD, exposure–response, and biomarker quantitative strategy; translate analyses into clear recommendations that inform patient-focused benefit–risk decisions.
• Advance pharmacometrics excellence through population modeling and simulation; set outsourcing approach and oversee partners for critical-path deliverables, timelines, and budget.
• Provide clinical pharmacology content for key program documents (e.g., protocol sections, Investigator’s Brochure contributions as applicable, and clinical study reports), ensuring data integrity and a clear scientific rationale.
• When opportunity appears, develop talent through hiring, coaching, mentoring, and performance management; set expectations for quality, compliance, and delivery across the team and external partners.
• Lead clinical pharmacology deliverables for regulatory interactions (e.g., briefing materials, responses, and meeting support) and maintain alignment to evolving global expectations.
• Support post-approval commitments and lifecycle management through design, execution, and interpretation of additional studies and quantitative analyses.
• Provide overall clinical pharmacology input to due diligence and business development activities, including assessment of available data packages and future development needs.
• Represent SMPA externally through publications, presentations, and collaborations that strengthen science and advance clinical pharmacology best practices.

Knowledge, Skills and Abilities (general & technical):

• Deep experience in the pharmaceutical/biotechnology industry, particularly in basic drug discovery and development research.

• Expertise in Phase 1 clinical study planning and execution (e.g., FIH, SAD, MAD, RI-AME, DDI, organ impairments, special populations, PET/EEG).
• Proficiency with Phoenix WinNonlin, and knowledgeable with advanced pharmacometrics tools for modeling & simulation.
• Proven leadership and collaboration skills in cross-cultural environments.
• Strong communication/negotiation and vendor management skills.

Education & Experience Requirements:

• PhD in Pharmaceutics, PharmD, or equivalent advanced degree required.
• 10+ years of experience in biotech/pharmaceutical drug development, including clinical pharmacology, PK/PK-PD, biomarkers, scientific writing, and regulatory interactions.
• Extensive experience in Clinical Pharmacology study design, planning, and execution.

Travel Requirements:

Primarily remote role with periodic on-site meetings in office. Must be able to travel domestically and internationally as needed. Willingness to travel approximately 10–20%.

Mental/Physical Requirements:

Fast-paced environment handling multiple demands is involved. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.

People Management

This position will start as an individual contributor role and does not have direct reports or formal people‑management responsibilities. However, this position may be developed to have people‑management responsibilities in near future, i.e. 1 or 2 years later.

The base salary range for this role is

Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state.  Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter.  Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Confidential Data: All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential, in accordance with applicable law.

Compliance: Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Mental/Physical Requirements:

Fast-paced environment handling multiple demands is involved. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.

Travel Requirements:

Primarily remote role with periodic on-site meetings in office. Must be able to travel domestically and internationally as needed.