Associate Director,
Clinical Development, #1749

(oncology focus)

 

 

Position #:                     #1749
Therapeutic Area:         Oncology           
Recruiting Status:          Exclusive Search
Classification:                Full-time Permanent position
Location:                       Raleigh-Durham, North Carolina area

EXPERIENCE – KEY AREAS:

  • MD Degree

  • Oncology clinical development experience

  • Industry experience (pharma, biopharma, or biotech) unless oncology board certified/eligible

 

 

POSITION SUMMARY

 

Responsibilities

  • 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.

  • Primary responsibility for the design and implementation of applicable clinical protocols, data collection systems, and final reports.

  • Responsible for assisting in the design of clinical development plans and overall strategy for compounds, therapeutic classes of compounds, or specific indications 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 the development of study protocols, clinical development strategy, and implementation of clinical strategy.

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

  • Participate in identification, selection, and conduct of negotiations with clinical research centers and investigators.

  • Participate in the selection and management activities of CROs.

  • Supervise project team members in planning, conducting and evaluating clinical trials.

  • Oversee the 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 ANDA applications.

  • Partner with direct manager and other members of the Clinical Development Leadership Team to facilitate governance and/or clinical development organizational meetings.

  • 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.

 

Experience and Education 

  •  MD required

  • 2+ years of experience in clinical research and/or oncology drug development in an academic, pharmaceutical, or CRO environment if oncology board certified/eligible OR 5+ years of experience in the pharmaceutical industry in a clinical development role if 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

 

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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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