Executive Director, Clinical Pharmacology - United States, United Kingdom, Switzerland
- Reporting to the Chief Scientific Officer, this person is responsible for establishing, leading and providing strategic direction to the Clinical Pharmacology group.
- The successful candidate will oversee the development and tactical execution of pharmacology plans for each product development program.
- Additional responsibilities include resourcing and managing external vendors, ensuring that all aspects of clinical pharmacology are strategically guided, appropriately resourced and effectively performed.
- This person will provide strategic input into the pharmacokinetic (PK) and pharmacodynamic (PD) components of product development programs; lead and/or aid in the design, analysis, interpretation and reporting of PK and (PD) data, as well as assay qualification, provide support for nonclinical toxicology studies, and lead or contribute significantly to the determination of appropriate dose and schedule for clinical studies including first in man studies.
- He/she will also provide support for regulatory reports, documents and filings.
- Responsible for establishing, building and providing strategic direction to the Clinical Pharmacology function at our company Therapeutics and oversee company-wide clinical pharmacology and bio analytical activities
- Accountable for the development of optimal bio marker approaches to early clinical development to identify, evaluate and validate novel endpoints for early decision making in preclinical and clinical PoC studies, in collaboration with other line functions
- Ensure appropriate clinical pharmacology and dose finding strategies that will help define optimal dose and schedule requirements
- Responsible for appropriate design and implementation of a clinical modeling and simulation plan as needed that conforms to appropriate regulatory guidelines
- Responsible for appropriately summarizing and interpreting results of PK and PK/PD analyses
- Accountable for the Clinical Pharmacology aspects of Integrated Development Plans, including necessary input into project team strategic and budget planning
- Contribute to and actively participate on development teams, and the relevant sub teams
- Perform PK, population PK and PK/PD analysis and modeling and simulation as needed
- Responsible for Clinical Pharmacology aspects of regulatory filings clinical protocol synopses and protocols, investigator brochures, and other documents as needed
- Ensure seamless communication and collaboration of Clinical Pharmacology across all areas of drug development
- PhD in pharmacokinetics, pharmacometrics, or closely related discipline with 12 years of professional experience in clinical pharmacology in the pharmaceutical industry, or equivalent combination of education and experience
- Effective communication skills including the ability to communicate complex topics to a diverse range of colleagues
- Thorough understanding and experience in the development of cell and gene therapies, , and knowledge of regulatory activities in US and EU, and direct experience with IND/CTA and NDA/BLA/MAA filings
- Proficiency with NONMEM, S-plus, and WinNonlin
- Demonstrated leadership skills and managerial experience, strong interpersonal skills
- Fluent English, excellent written and verbal communication skills with successful presentation capabilities required.
- Includes the above qualifications plus 15+ years of industry experience
- Experience with both IND and European CTA filings
- Successful experience with MAA/BLA filings
- Experience growing a pharmacology organization
- Attracting and Developing Talent/Building a Successful Team – The ability to assess gaps in the organization and recruit, assess and grow talent effectively to address those gaps. Building an effective group that contributes to the larger success of the organization through setting clear expectations, providing context and building commitment.
- Customer Focus / Customer Partnering – The desire to understand and anticipate internal/external customer needs and take action to meet or exceed these needs. The ability to develop and foster relationships of trust and mutual respect through assuring accessibility and responsiveness. Demonstrates knowledge of the customer’s function including key issues, processes, metrics, goals, needs and terminology. Proactively works with customer to address issues.
- Job Knowledge – Achieves and maintains technical and professional proficiency related to current job position and areas of expertise.
- Leverage Vendor Resources – Understands vendor needs, interests and full range of offerings and maximizes benefits to the Company. Manages vendors effectively.
- Problem Solving / Perseverance – The ability to understand a situation, task or problem by breaking it down into smaller pieces using a systematic approach and to identify patterns and connections between situations that are not obviously related. Pursues tasks with energy, drive and initiative, even in the face of adversity.
- Productive Work Habits/ Results Oriented – Skilled at analyzing scope of work, as well as planning and executing a successful outcome. Understands and assigns resources effectively. Drives issues to closure and gets the job done.