The head of Clinical and Preclinical Pharmacology will provide leadership across the company’s therapeutic areas to ensure the successful design and implementation of Clinical and Preclinical Pharmacology Plans. Major areas of responsibility include leadership to the design and ownership of the Clinical and Preclinical Pharmacology Plans, oversight of all clinical pharmacology aspects of clinical trial and program level activities, lead the evaluation and interpretation of clinical and preclinical pharmacology data and strategic/expert contributions to regulatory submissions, publications, and presentations.
This position is specifically responsible for developing and leading the clinical and preclinical pharmacology strategy in alignment with the business and R&D strategies. This role will generally be the key point of contact for all clinical pharmacology-related activities across all therapeutic areas.
typical roles and responsibilities for Director Clinical Pharmacology
- Translate concepts/strategies into specific clinical and pre-clinical objectives and activities to effectively achieve goals by leveraging and motivating cross-functional stakeholders.
- Interact internally and externally with executive level management requiring negotiation to influence decision-making bodies and to facilitate clinical and preclinical pharmacology research.
- Ensure appropriate scientific rigor in the design, conduct, validity, and interpretation of early phase clinical trials / preclinical studies to support regulatory applications or business/marketing objectives.
- Identify and evaluate complex problems where analysis of situations or data requires an in-depth evaluation of various factors.
- Identify significant issues that may impact overall project plans and initiate contingency plans as appropriate.
- Contribute to the strategic planning, authoring, and review of regulatory documents, scientific data disclosures, and commercial support documents, ensuring documents are are in alignment with R&D strategy.
- Provide subject-matter expertise and support to externally facing groups, including the field medical team, medical information, research and development strategy team, and the commercial organization as needed.
- Contribute to departmental resource planning, budgeting, and timeline setting to meet company needs.
- Demonstrated capability to provide direct oversight and coaching to clinical pharmacology and preclinical scientists.
- Lead the development of and keep current comprehensive clinical and preclinical pharmacology strategic development plans across all therapeutic areas (i.e., Cholestasis or NASH).
- Lead all clinical pharmacology aspects of clinical trial(s) and program level activities as assigned, providing subject matter expertise to study protocols, statistical analysis plans, interpretation of results, clinical study reports, etc.
- Deliver high-quality evaluation and interpretation of clinical pharmacology data (pharmacokinetics, pharmacodynamics, safety, dose, or concentration/response relationships).
- Review and conduct pharmacometrics-based analyses; Design and analyze cross-trial pharmacokinetic-pharmacodynamic analysis, conduct simulations (e.g., trial design, efficacy-safety in new populations) based on prior data and models.
- Lead all in vivo/ in vitro studies involving pharmacokinetics, drug metabolism, enzyme kinetics, and drug transport.
- Contribute to the strategic planning, authoring, and review of regulatory documents providing direct leadership/oversight to clinical and preclinical pharmacology sections of these documents; Serve as primary clinical pharmacology representative in support of regulatory interactions.
- Provide subject matter expertise to scientific data disclosures including publications and commercial support documents, ensuring strategic intent is aligned with corporate and R&D strategy.
- Provide subject matter expertise and support to externally facing groups, including the field medical team, medical information, and the commercial organization.
- Build productive relationships with investigators, key opinion leaders, and key stakeholders in the medical/scientific community.
- Represent clinical and preclinical pharmacology projects to corporate partners, investors and clinical investigators as required.
- Maintain clinical and technical expertise in the therapeutic area; consistent review of scientific journals, attend scientific and key technical meetings and partner with company medical, research and commercial teams.
- Assist in accomplishing clinical development department and corporate objectives as it relates to the clinical and preclinical pharmacology plans across therapeutic areas.
- Develop accurate budget projections to support the team’s goals and provide oversight of the budget.
- Management of multiple personnel within the Clinical and Preclinical line function
Requirements for Director Clinical Pharmacology – Scientific
- Pharm D. or Ph.D. in a related field preferred with 10 years or more direct biotechnology or pharmaceutical industry experience in Clinical and Preclinical Pharmacology.
- In-depth understanding and proficiency in clinical pharmacokinetic (experienced in non-compartmental and population pharmacokinetics), pharmacodynamic, and PK/PD analyses; Strong understanding of the fundamental and underlying sciences associated with clinical pharmacology.
- Ability to integrate biological systems, physiology, pharmacology, and biochemistry with PK/PD and drug development.
- Demonstrated record of overseeing the successful planning and implementation of clinical and preclinical pharmacology components of development plans and global regulatory submissions.
- Proven leadership abilities in a highly complex and fast-paced environment where negotiation skills are essential for success. Must be able to work on multiple complex projects simultaneously.
- Outstanding scientific leadership, collaboration, and management skills with an integrated view of business and scientific issues
- Demonstrated problem solving skills (including taking ownership to ensure timely resolution), a strong sense of urgency, keen attention to detail, and the ability to successfully execute in an environment under time and resource pressures.
- Strong communication skills, including writing and presentation skills, with success in influencing at all levels cross-functionally.
- Proven abilities in developing overall resource plans (both internal resource and outsourcing) and providing oversight to Clinical and Preclinical pharmacology vendors/CROs
- Demonstrated record of management of multiple personnel within the Clinical and Preclinical line function
Required Knowledge and Abilities:
- Knowledge of GCPs, ICH guidelines and FDA regulations and familiarity with EMA/CHMP regulations and guidelines, and other international regulatory requirements.
- Highly proficient in standard computer software (Word, Excel, and Power Point).
- Ability to travel, in some cases, internationally. Average travel expectations: 10-20%/year.