Director/Senior Director DMPK

Location
San Diego (Sorrento Valley), California
Posted
Mar 01, 2018
Required Education
Doctorate/PHD/MD
Position Type
Full time

Crinetics Pharmaceuticals is seeking an experienced highly motivated Drug Metabolism and Pharmacokinetics (DM and PK) professional to join its growing and dynamic development team. This individual will be an integral part of the company’s efforts to discover and develop small molecule therapeutics for rare endocrine disorders and endocrine-related cancers. This is a unique opportunity to work with a proven and well-funded drug discovery and development team in a small company environment in the heart of San Diego’s biotechnology community.

Responsibilities

  • Develop and provide high level guidance to senior management on nonclinical and clinical DMPK, bioanalysis for drug and biomarkers, and pharmacometrics for all Crinetics’ drug development programs
  • Manage a team involved in DM and PK studies to support transition of compounds from drug discovery to development
  • Oversee all aspects of nonclinical and clinical bioanalysis, DM and PK in support of development programs
  • Identify and propose timing for clinical pharmacology studies needed to support clinical trials and NDA submissions
  • Implement an efficient population PK and exposure response strategy to support clinical trials, justification of dosing regimen, and provide supportive evidence of efficacy and safety for regulatory submissions
  • Identify, liaison with partners for development and validation of methods of bioanalysis of biomarkers and drug levels using the state-of-the-art and well accepted methodologies (including immunoassays, mass spectroscopy, and genotyping based technologies)
  • Assist in preparation of regulatory dossier (including INDs, IMPDs, NDAs, briefing packages or other regulatory dossier)
  • Attend and participate in meetings with FDA and ex-US regulatory authorities
  • Be conversant with bioanalysis and clinical pharmacology guidances, and identify areas of risk
  • Participate in development of program timelines
  • Monitor, communicate and manage budgets for their functional area.
  • Responsible for vendor and qualification activities.
  • Set clear outcomes/deliverables for projects and own them, staying accountable to the company management team
  • Ensure compliance with Crinetics’ SOPs and GXPs
  • Develop relationships with external parties (eg, CROs, consultants, QA and regulatory professionals) and stay current on industry trends and practices
  • Set high standards on deliverables while managing risks and timelines
  • Provide guidance/tutoring and train staff members as necessary.  Provide regular feedback and coaching for their professional development
  • Other tasks as assigned.

Minimum Qualifications

  • PhD in biological sciences or related discipline with at least 10 years of related experience OR BS with 15 years of related experience
  • Prior experience working at a small company with wide ranging related responsibilities is desired
  • Prior experience in drug development functions (e.g., Nonclinical and Clinical) is desired
  • Prior experience managing third parties and external service providers (worldwide) and consultants is preferred
  • Excellent writing skills as they relate to preparation of regulatory documents
  • Excellent interpersonal skills with strong oral/written communication and presentation skills
  • Excellent negotiation skills and a tactful approach that leads to high value on outcomes achieved
  • Experience in managing teams (including external service providers and consultants)
  • Excellent problem-solving ability
  • Excellent command of applicable GLPs
  • Leadership and management skills, and, demonstrated qualities in this area
  • Demonstration of cross-functional understanding related to drug development
  • Good judge of risks and a keen ability to analyze options and manage outcomes
  • Well versed with the latest trends in the drug development industry, including working knowledge of PK/PD software (e.g., Phoenix Winnonlin)

Travel

Travel (national and international) may be required up to 10% of your time