Director/Senior Director – Clinical Pharmacology

Position: Director/Senior Director - Clinical Pharmacology

Function: Clinical Pharmacology

Company: Phanes Therapeutics, Inc.

Location: San Diego, CA

Phanes Therapeutics is an emerging leader in drug discovery in immuno-oncology and eye disease. We are looking for motivated and passionate people to join us to help discover and develop new medicines and improve healthcare. We believe that innovative thinking, seamless execution, teamwork, and integrity are key values for building success. Our mission is to become a major source of innovation in the biotech and pharma industry.

At Phanes, we understand that scientific innovation is a challenging task and that’s why we are looking for exceptionally talented people to join us on our mission. We are committed to fostering an innovative and fun working environment where one can pursue creative ideas and deliver results, because we know that our success depends on how to realize the true potential of our people. We offer competitive compensation and excellent medical, dental and vision benefits, and excellent career growth opportunities.

This position is in the clinical pharmacology function and will work at our research site in San Diego, CA. Ideally the candidate should have solid training and/or broad experiences in Oncology. The candidate will work independently or lead a team to advance preclinical lead molecules into Phase I clinical development and beyond.

Key responsibilities:

  1. Providing strategic leadership and accountability for clinical pharmacology programs supporting IND and Phase 1-4 clinical development.
  2. Hands-on analysis and interpretation of pre-clinical/clinical PK/PD data, integrating clinical trial simulation strategies and articulating the relevant risk/benefit implications to the larger team.
  3. Work with Discovery research to ensure quantitative mechanistic understanding and preclinical PK-PD knowledge exist to underwrite human administration requirements.
  4. Developing and implementing new clinical pharmacology tools and technologies to drive smarter drug development for programs.
  5. Developing and maintaining collaborative working relationship with colleagues within and outside the department.
  6. Authoring/reviewing/approving clinical protocols, analysis plans, study reports and regulatory submissions.
  7. Developing high quality clinical pharmacology plans and content for regulatory submissions, including INDs, IBs, NDAs, and pediatric plans.
  8. Maintaining and establishing relationships and agreements with contract vendors.
  9. Supervising, developing, and mentoring junior level scientists.

Qualifications:

  1. At least 8 years of industry or equivalent experience and a PhD, PharmD or equivalent degree with emphasis in Clinical Pharmacology, Pharmacokinetics, Pharmacometrics or a closely related scientific discipline.
  2. Experience in developing and implementing clinical pharmacology and modeling/simulation strategies for novel modalities (example: mAbs, bi-specific Abs, antibody drug conjugates, etc.). Oncology experience highly preferred.
  3. Expertise with standard modelling and simulation software (NONMEM, S-Plus/R, etc.) is required. Knowledge of WinNonlin required.
  4. Extensive experience in population modeling and simulations.
  5. Thorough knowledge of current and emerging scientific standards regulatory requirements.
  6. Excellent written and oral communication skills and ability to convey complex technical information clearly and coordinate with external collaborators as a scientific leader.
  7. Confidence and ability to present to and influence senior leaders.
  8. Ability to critically analyze problems and provide creative solutions.
  9. Confidence and discipline to work autonomously.
  10. Present posters and/or give oral presentations in internal meetings and external scientific conferences.