Associate Director, Clinical Pharmacology in San Diego, CA

$100K - $150K(Ladders Estimates)

Halozyme Therapeutics, Inc   •  

San Diego, CA 92101

Industry: Pharmaceuticals & Biotech

  •  

5 - 7 years

Posted 40 days ago

POSITION SUMMARY:

The Associate Director, Clinical Pharmacology will be responsible for supporting clinical development through study design, PK and PK/PD analyses, and regulatory submissions. The candidate will have expert knowledge of Clinical Pharmacology including PK drug metabolism and drug-drug interactions. The individual will prepare relevant presentations and technical reports for internal communication, including but not limited to regulatory filings, partner support, research meetings, academic collaborations and CSRs.

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:

These may include but are not limited to:


  • Contribute to clinical protocol development from a clinical pharmacology perspective, including PK design and clinical pharmacology data analysis plans
  • Analyze clinical pharmacology data (PK and PK/PD) from clinical studies, and PK data from nonclinical studies using WinNonlin as well as other pharmacokinetic/pharmacodynamics (PK/PD) modeling software
  • Interpret scientific data from a clinical pharmacology perspective and incorporate appropriate analyses into reports required for regulatory submissions
  • Contribute to clinical development plans, Investigator's Brochure and Clinical Pharmacology sections of INDs, CTAs and/or NDAs/BLAs/MAAs with supervision
  • Review, analyze and provide interpretation of clinical trials at all phases, including phase III planning and data analysis plans
  • Author technical reports and meeting abstracts, prepare data, figures and contribute to authoring of manuscripts for publication, and represent Halozyme as a Subject Matter Expert (SME) at conferences and workshops
  • Participate in cross-functional project team meetings, provide feedback on experimental work and guide strategies for accomplishing relevant goals
  • Work independently to meet corporate goals and objectives

ADDITIONAL FUNCTIONS AND RESPONSIBILITIES:


  • Recommend pharmacokinetic software as needed to ensure current, cutting edge data analysis
  • Provide technical support to nonclinical pharmacology, toxicology, clinical development and clinical operations
  • Enhance professional growth and development through participation in educational programs, current literature, in-service meetings and workshops
  • Other duties as assigned

EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES:


  • A minimum of a Ph.D. in Pharmaceutical Sciences or related area with at least 5 years' experience in clinical pharmacology in the pharmaceutical or biotech industry (an equivalent combination of experience and education may be considered)
  • Proven understanding and experience in protein drug metabolism, drug-drug interactions and protein/drug properties governing in vivo distribution
  • Comply with established company policies and procedures, objectives, quality assurance program, safety and environmental standards
  • Strong presentation skills, and human relations skills
  • Ability to write clear, concise technical reports and attention to detail is essential
  • Clear and effective written and verbal communication skills

TECHNICAL KNOWLEDGE REQUIRED:

Equipment: PC, scanners, facsimile machine, voice mail and e-mail systems, and common office machines, or ability to be trained. Knowledge of other equipment required: N/A

Software Knowledge: Windows, MS Office (Outlook, Word, Excel). Knowledge of other software required: PK software (Phoenix WNL)

INTERNAL AND EXTERNAL RELATIONSHIPS:


  • Internal interaction with Clinical, nonclinical, Regulatory, and other groups
  • External interaction with academic labs, CROs, and collaborators
  • Collaborate with internal and external PK/PD subject matter experts and consultants

EFFORT REQUIRED/ENVIRONMENTAL CONDITIONS:

Physical Activities: On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 20 lbs. may be required. The noise level in the work environment is usually low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities.

Laboratory Activities, if applicable: Biology and chemical laboratory environments experience needed. Environmental health and safety requirements also apply.

Valid Through: 2019-10-2