Director, Clinical Development, #1751

LOCATION:   Durham-Raleigh-RTP area of North Carolina

SEEKING:      MD with oncology Clinical Development background

 

COMPANY:   A public company founded in 2008     Rated in 2018 as one of the best places to work in the area.   Approximately 100 employees
 

TYPE OF SEARCH:     Exclusive (no other recruiting firms engaged)

Note:   The position Assoc. Director/Director Clinical Scientist is also available, and  
the job description may be found at:   www.slcollins.com/1752

 


POSITION SUMMARY

 

Essential Duties & Responsibilities

  • Providing scientific and medical expertise to the design and implementation of phase I-III clinical studies to drive successful global filings.

  • Providing strategic and operational guidance to teams, based on medical and scientific expertise and sound clinical judgment.

  • Oversite of CRO medical monitors with primary sponsor responsibility for patient safety and conduct of assigned trials as well as overall data interpretation and safety surveillance.

  • Interacts closely with the pre-clinical team, to understand the scientific basis of targeted therapy, and to apply this knowledge to articulating therapeutic strategies and comprehending biomarker exploration

  • Responsible for clinical development plans and overall strategy for assigned compounds while taking into consideration ongoing developments in the area of clinical oncology and oncology drug development.

  • Collaborate with pre-clinical, translational sciences, regulatory, and senior management in development of study protocols, clinical development strategy, and implementation of clinical strategy.

  • Provide leadership on cross-functional product development team(s) as experience allows.

  • Build and maintain solid working relationships with key opinion leaders, and lead clinical investigators.

  • Oversee planning and management of investigator meetings, advisory boards and other scientific committees.

  • Partner with development team leads to formulate strategy and coordinate cross-functional planning and execution across multiple indications. Participates with clinical development in all aspects of NDA and sNDA applications.

  • Engage with stakeholders at all levels of the organization to solicit input and feedback. Incorporate learnings into team direction setting, problem resolution and lessons learned activities.

  • Motivate and facilitate informed, timely, and impactful decision making across the organization.

  • Develop and maintain a high performing operational approach including effective team building and conflict management. Identify situations requiring escalation.

  • Create a team environment that encourages cross-functional engagement, cooperation, accountability, and satisfaction.

  • Other duties as assigned.


Requirements
 

  • MD required

  • 5+ years of experience in clinical research and/or oncology drug development in an academic, pharmaceutical, or CRO environment if oncology board certified/eligible OR 8+ years of experience in the pharmaceutical industry in a clinical development role if the physician has oncology experience but is not oncology board certified/eligible

  • Oncology experience required

  • Experience with the clinical drug development process

  • Scientific research and writing skills required. Ability to critically evaluate the published medical and scientific literature and approve and write comprehensive, medically accurate and scientifically fair-balanced documents

  • Ability to handle complexity, prioritize and multi-task current project demands. Must be able to prioritize and deliver effectively with minimal supervision

  • Proven leadership skills and demonstrated ability to interact collaboratively in a cross-functional environment

  • Ability to make sound and timely decisions; agile in learning and action oriented

  • High level of emotional intelligence; able to deal with ambiguity

  • Able to relate to varied level audiences across the organization; able to set priorities for team and maintain accountability; skillful in negotiating organizational boundaries and hierarchy; able to build effective teams

  • Excellent written and verbal communication skills required

  • 15-20% travel

 

 

NEXT STEP OPTIONS:
 

 

Should you elect to send your resume to us, we will never forward it to anyone without first contacting you and receiving your approval to do so.

 

NOTE:   This is an unofficial document prepared by S L Collins Associates, Inc. to provide basic information concerning the position.   The company we are conducting this search for has the official job description.

 

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