Director, Pharmacology

Location
San Diego, CA, US
Posted
Oct 05, 2020
Ref
308296
Hotbed
Biotech Beach
Required Education
Doctorate/PHD/MD
Position Type
Full time
This position is a key member and leader of the team in executing early clinical drug development activities evaluating the pharmacology and toxicology of antibody therapeutics focused primarily, but not exclusively, on immune-inflammatory diseases. As a key member of the development team, this role liaises with Discovery Project Team Leaders and the VP, Pharmacology &Toxicology serve., where appropriate, and work collaboratively with the executive management to develop of key program strategies, and strengthen the capabilities of the company.

Essential Functions

• Lead the clinical pharmacology strategy including modeling & simulation to contribute to the development of compounds

• Plan, execute, and report on model-based pharmacokinetic and exposure-response analyses of data from clinical studies

• Represent the Clinical Pharmacology function on cross-functional teams, contribute to design drug development strategies, regulatory submissions, and participate in interactions with health authorities

• Contribute clinical pharmacology sections of clinical study protocols and reports and regulatory documents including Investigator Brochures, and IND/NDA/IMPDs/sNDAs

• Provide oversight of all clinical pharmacology aspects of a clinical study and Contract Research Organizations or vendors to ensure timely deliverables with high quality results

• Ability to craft pre-clinical and clinical pharmacological strategies, including dose escalation, contributing to stopping rules, and risk-benefit to ascertain that compounds are entered into man safely, efficiently and with scientific validity.

• Oversees the development and validation of quantitative in vivo assays to enable pharmacological characterization of therapeutic antibodies

• Supervise and mentor junior clinical pharmacologist, if needed

• Participate in multidisciplinary teams in supporting due diligence efforts for new business opportunities that are under consideration and managing clinical pharmacology alliance with current and potential partners, if needed

• Establishes collaboration with CROs andor academic institutions to develop in vivo pharmacology models to permit progression into the clinic of therapeutic antibodies

• Provides strategic and tactical direction to multiple project teams

• Prepares study reports for regulatory submission on development candidates

• Contributes to new project ideas and in vivo proof-of-concept studies to enable the initiation of new antibody projects

Supervisory Responsibilities

Hire, lead, and develop Pharmacology team

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.

Requirements

Qualifications

Education & Experience

• PharmD with post-doctoral training or PhD in pharmaceutical sciences, pharmacology, or a related field

• 8+ years of experience in clinical pharmacology and/or pharmacometrics, ideally experience in biopharmaceuticals

• In-depth knowledge of current practices and issues in clinical pharmacology and pharmacometrics.

• Extensive experience in developing quantitative in vivo pharmacodynamic assays and preclinical disease models to assess target engagement and efficacy in a range of inflammatory/autoimmune conditions

• Ability to work effectively both independently, and collaboratively in a dynamic team-oriented environment, balancing multiple responsibilities, projects and teams simultaneously.

• Demonstrate the ability to work in a dynamic fast-paced environment

• Strong written and oral communication skills necessary to report on and deliver scientific reports and presentations

• Prior experience of working across diverse therapeutic areas is highly desirable.

Knowledge

• Direct experience and knowledge of all the requirements for clinical Pharmacology needed to progress to first-in-human studies and different stage of clinical development

• Sound theoretical and experimental background in biology coupled with a solid foundation in quantitative pharmacology

• Ability to perform randomized controlled clinical trial principles, methodology and procedures.

• Skilled at statistical data collection, editing, validation and analysis techniques.

Personal Competencies

• Excellent team skills and proven ability to work within multi-disciplinary teams to influence the overall direction of projects

• Excellent communication and interpersonal skills, with the ability to effectively influence opinion and actions, and communicate strategies, plans, results and analysis, at all levels within an organization, including third parties such as CRO's and collaborative partners.Strong publication record in reputed pharmacology journals

• Ability to think strategically and to provide clear direction and expectation to other team members in a highly dynamic environment.

• Strong ability to prioritize daily work based on changing business requirements.

• Self-motivated, independent, and results-oriented

• Ability to work productively in a matrix environment, as both a team contributor and team leader, taking ownership of multiple projects.

Work Environment

The work environment characteristics are representative of those an employee encounters while performing the essential functions of this job, typically in an open office environment or laboratory. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The noise level in the work environment is usually quiet to moderate.

This position requires working with biological and/or chemical hazards

May be required to travel by plane about 20% of the time