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Careers > Director, Clinical Pharmacology

The Director, Clinical Pharmacology will be responsible for integrating metabolism, pharmacokinetics, pharmacodynamics, toxicology, toxicokinetics, bioanalysis, ADME HTS, drug formulations and drug delivery efforts to support the Company’s development of oncology and immuno therapies. 

Responsibilities include (but not limited to):

• Manage, define and plan clinical pharmacology projects, resources, budgets and major milestones, and identify critical path issues.
• Design, conduct and monitor clinical toxicology, ADME, pharmacokinetic, and pharmacology studies
• Participate on multidisciplinary project teams or task forces.
• Identify investigators, collaborators and vendors to perform services. Negotiate clinical pharmacology, study designs, budgets, timelines and contracts.
• Effectively Interact with and make presentations to members of national and international regulatory agencies.
• Proposed development and regulatory strategies for lead compounds
• Write clinical NDA sections, FDA briefing packages 

Requirements:

PharmD with 7+ years of industry experience; early stage clinical development experience required, later phase experience preferred.Knowledgeable in FDA, EMEA and ICH regulatory guidelines;

• Previous experience working with projects requiring accuracy and attention to detail with the proven ability to work independently under aggressive timelines
• Experience with Pharmacokinetic and Pharmacodynamic methodologies and analyses in preparation of clinical studies reports and integrated summary documents.
• Proficient in multiple computer software programs including word-processing, spreadsheets, mathematical and statistical packages, project management, and the Internet.
• Excellent communication, organization and scientific writing skills
• Effective interpersonal skills including a positive and constructive attitude and the desire and ability to work in a project matrix environment
• Development experience within oncology and immunology therapeutic areas preferred
• Experience in biotech preferred with some functional  management
• Ability to adapt to a changing work environment and a growing company is essential. 
• Effective record keeping and presentation skills are required as well as the ability to effectively collaborate with other team members within the group and company.

Please send all inquiries to careers@proteolix.com. No agencies please.

Proteolix offers competitive compensation and benefits, equity participation, and an interactive, professional environment that recognizes/rewards achievements. We are proud to be an equal opportunity employer.

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