Executive Director, Clinical Development

Pharmacyclics

Pleasanton, CA

JOB DETAILS
LOCATION
Pleasanton, CA
POSTED
30+ days ago

Description

The Executive Director will serve as the Clinical Development lead, within the R&D organization, for clinical and scientific assessment of external opportunities working closely with the Search & Evaluation team and the Business Development and Acquisitions team.

The Executive Director will be a key member of a highly integrated approach to developing and sustaining our partnerships. You will be part of a one connected unit with a commitment to establishing collaborations across the development continuum that will ultimately benefit patients and fuel scientific progress.

The Executive Director will provide leadership support to the team, helping to drive towards strong partnerships in a highly competitive field.

You will bring innovation and a dynamic focus to the high-profile Aesthetic Medicine business and seek ways to apply established clinical development experience alongside new fresh thinking.

The Executive Director should expect to be asked to participate in internal process improvement activities within R&D and Clinical Development, as well as mentor and provide guidance to junior team members. 

 

Responsibilities:

1. As the Therapeutic Area (TA) Section Head, be responsible and accountable for the oversight and leadership of the Clinical Development staff and Clinical Development programs in the Body Contouring and Plastics and Regenerative Medicine Franchises in Aesthetic Medicine, Device Section. Additional TA Section Head responsibilities will include:

  • Leading and acting as the key point of accountability for the development activities across multiple devices and indications within the TA Section.
  • Representing Clinical Development in decision-making forums and bringing strategic thinking to high level discussions.
  • Ensuring clinical perspective is evaluated and optimal pathways are brought to the discussion with respect to physician and patient needs balanced with a key focus on commercial needs.
  • Leading, mentoring and overseeing team members.
  • Working cross-functionally with multiple functions including Commercial, Medical Affairs, Regulatory, Data Sciences and Statistics, Safety and Product Development.
  • Committing to high standards always with respect to data integrity, patient-centricity and global competitive development.
  • Representing the TA Section at Regulatory agencies or other relevant meetings.
  • Establishing and maintaining a strong network of peers within the Biotech industry.
  • Representing R&D at scheduled symposia and meetings.
  • Working closely with the Clinical Development Lead for Business Development in the assessment and review/due diligence of in-licensing opportunities.
  • Working closely with the Digital Science and Technology Lead and Clinical Innovation Leads within the Clinical Development group to support research applications and endpoint advancement.

2. As the Clinical Program Lead, be responsible and accountable for the development, implementation and delivery of the global clinical development strategy for a given project within time, budget and with high quality. He/she will lead the development of the Clinical Development Plan in collaboration with the Clinical Science Lead and members of the Integrated Evidence Strategy Team, ensuring alignment with the agreed Global Development Strategy.

#-PD1

Qualifications

  • Advanced Degree required. Scientific knowledge and experience in Aesthetic Medicine and Medical Device preferred.
  • A good solid knowledge of regulatory pathways is preferred.
  • Proven success leading in a cross functional environment.
  • A strong network of thought leaders across Aesthetic Medicine is preferred.
  • A minimum 12 years of overall work experience or equivalent combination of experience and education, with ideally at least 15 years’ experience.
  • Of the overall work experience, a minimum of 6 years of clinical development experience in the pharmaceutical/device industry.
  • The ability to travel up to 25-30% of time as needed (to include international travel)