Scientific Director

Biotrial is seeking a Scientific Director / Clinical Pharmacologist to help with study design, oversight of early phase trials and can
immediately contribute to critical clinical pharmacology activities. This individual must possess the expertise to lead
and/or participate in all steps of clinical study design, data analysis, and interpretation, with a particular focus on
pharmacokinetics and pharmacodynamics.

Responsibilities include but not limited to:

- Lead and/or participate in Phase 1 through Phase 4 clinical study design, planning, data analysis and
interpretation with a focus on translational medicine and early phase trials.
- Lead and/or participate in activities related to dose selection, characterization of exposure-response
relationships, and characterization of potential effects of intrinsic and extrinsic factors on pharmacokinetics and
pharmacodynamics.
- Review and approve sponsor protocol design to ensure that studies are conducted in accordance with applicable
regulations.
- Oversee and contribute to population PK and PK/PD modelling efforts.
- Participate on cross functional project and study teams to ensure integration of clinical pharmacology principles
into project plans throughout the product lifecycle. Support regulatory filings, participate in meetings with
regulatory authorities, and address queries from regulatory agencies.
- Analyze data to assess the safety and efficacy of drugs.
- Assess drug safety and efficacy for regulatory approval.
- Interpret the results of clinical trials and making recommendations for further research and development.
- Select and manage consultants and vendors that support clinical pharmacology activities.
- Identify and escalate critical issues.

**Requirements**:

- Medical degree (MD) or Doctor of Pharmacy (PharmD) or PhD.
- Advanced training in clinical pharmacology through a fellowship or residency program.
- Strong understanding of pharmacology, pharmacokinetics, and pharmacodynamics.
- Excellent analytical and data interpretation skills.
- 3+ years of industry experience, preferably in pharmacokinetics and/or clinical pharmacology.
- Ability to work effectively cross culturally and cross functionally and value the importance of teamwork.
- Demonstrated flexibility in responding to changing priorities or dealing with unexpected events.
- Capable of working effectively with little direction.
- Willingness to take on responsibilities outside of specific job requirements.

What we offer:

- An integration program is organized for new arrivals
- Easy acces to our sites

Qui sommes nous ?

Biotrial is a long-standing service provider to the pharmaceutical industry, supporting clients through every stage of drug and medical device development for over 35 years. A recognized leader in early-stage development, Biotrial plays a key role in some of the most advanced and innovative fields of research, including non-clinical pharmacology, clinical trials, oncology, bioanalysis, and data management.