Head of Clinical Pharmacology

About the role

As the Head of Clinical Pharmacology at Bamboohr, you will play a role in advancing our innovative therapeutic solutions. This position requires a strategic leader who can guide the clinical pharmacology team in designing and implementing clinical studies that evaluate the safety and efficacy of our drug candidates. You will collaborate closely with cross-functional teams, including research, regulatory affairs, and clinical operations, to ensure that our pharmacological strategies align with the overall goals of the organization. Your expertise will be essential in navigating the complexities of drug development, from preclinical phases through to clinical trials, ensuring that our products meet the highest standards of quality and compliance.

Key facts

What you'll do

• Lead the clinical pharmacology team in the design and execution of clinical studies, ensuring alignment with regulatory requirements and industry best practices.
• Develop and implement pharmacokinetic (PK) and pharmacodynamic (PD) strategies to support clinical development programs.
• Collaborate with cross-functional teams to integrate pharmacology data into clinical trial designs and regulatory submissions.
• Oversee the analysis and interpretation of clinical data, providing insights that inform decision-making and strategy.
• Serve as a key point of contact for regulatory agencies, ensuring that all submissions are scientifically sound and compliant with applicable regulations.
• Mentor and develop junior staff within the clinical pharmacology team, fostering a culture of continuous learning and professional growth.
• Stay abreast of industry trends and advancements in clinical pharmacology, applying this knowledge to enhance the company's drug development processes.
• Contribute to the preparation of scientific publications and presentations, showcasing the company's research and development efforts.
• Collaborate with external partners and stakeholders, including academic institutions and contract research organizations (CROs), to advance clinical programs.
• Ensure that all clinical pharmacology activities are conducted in accordance with Good Clinical Practice (GCP) and other relevant guidelines.
• Lead the development of pharmacology-related sections of regulatory submissions, including INDs and NDAs.
• Participate in strategic planning sessions to align clinical pharmacology objectives with the overall mission and vision of Bamboohr.

Requirements

• PhD or PharmD in pharmacology, pharmaceutical sciences, or a related field.
• A minimum of 8 years of experience in clinical pharmacology, with a strong background in drug development and regulatory submissions.
• Proven track record of leading clinical pharmacology studies and managing cross-functional teams.
• In-depth knowledge of pharmacokinetics, pharmacodynamics, and biopharmaceutics.
• Experience interacting with regulatory agencies, including the FDA and EMA.
• Strong analytical skills with the ability to interpret complex data and communicate findings effectively.
• Excellent leadership and interpersonal skills, with a demonstrated ability to mentor and develop team members.
• Familiarity with clinical trial design and execution, including experience with Phase I-IV studies.
• Strong organizational skills and the ability to manage multiple projects simultaneously.

Nice to have

• Experience in a biotech or pharmaceutical company focused on oncology or rare diseases.
• Familiarity with statistical software and modeling tools used in pharmacokinetic analysis.
• Previous experience in a start-up environment, demonstrating adaptability and innovation.
• Publications in peer-reviewed journals related to clinical pharmacology or drug development.
• Knowledge of global regulatory requirements and guidelines.

Skills & tools

• Proficient in pharmacokinetic modeling software (e.g., NONMEM, Phoenix WinNonlin).
• Strong understanding of clinical trial management systems (CTMS) and electronic data capture (EDC) tools.
• Familiarity with statistical analysis software (e.g., SAS, R).
• Excellent communication skills, both written and verbal, for effective collaboration with internal and external stakeholders.
• Ability to work collaboratively in a fast-paced, team-oriented environment.

Practical notes

• This position is based in South San Francisco, California, and may require occasional travel for meetings and conferences.
• The ideal candidate will be expected to demonstrate a commitment to the mission and values of Bamboohr, contributing to a culture of innovation and excellence.
• Bamboohr is an equal opportunity employer and encourages applications from individuals of diverse backgrounds.

If you are a strategic thinker with a passion for advancing clinical pharmacology in a dynamic environment, we invite you to apply for the Head of Clinical Pharmacology position at Bamboohr. Join us in our mission to develop therapies that improve patient outcomes.

About the company

Medicine is our platform. Accessibility is our cure.