Assoc. Director/Director
Clinical Scientist   #1752

LOCATION:   Durham-Raleigh-RTP area of North Carolina

SEEKING:      Advanced Degree preferred with oncology clinical research/development experience

 

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/1751

 


POSITION SUMMARY

                       
The Associate Dir./Director Clinical Scientist is a key member of the clinical development team for the planning, conduct, analysis, and reporting of clinical studies. This position works independently across functional teams to ensure the timely execution of the clinical development plan.  Requires minimal supervision in the development of protocols, analysis of clinical trial data, literature searches, and summary of key data.  Closely collaborates with Clinical Operations in the overall conduct and timely execution of clinical trials. Works in collaboration with other key stakeholders in the development of the clinical program strategy and other activities towards achieving corporate objectives.

Essential Duties & Responsibilities

  • Author key technical and clinical documents, including but not limited to, clinical study protocols, clinical study reports, investigator brochures, annual reports and clinical sections of regulatory submissions

  • In conjunction with the clinical operations team, participate in the selection of investigators, clinical sites, and vendors (including CRO)

  • Accountable for the clinical/scientific execution of the clinical protocol.

  • Accountable for the scientific aspects of the implementation and conduct of a clinical trial (e.g., investigator meeting presentations, safety and medical monitoring)

  • Create and maintain clinical development plans to be aligned with Target Product Profile

  • Develop and perform clinical data review plans for clinical studies

  • Participate in and prepare presentations for scientific meetings such as DSMB, steering committees, scientific advisory boards, etc.

  • Builds relationships with external scientific and clinical thought leaders

  • Author abstracts and prepare posters for external presentation

  • Establishing and approving scientific methods for design and implementation of clinical protocols, data collection systems (eCRF), and final reports

  • Coordinate efforts and collaborate with internal stakeholders (i.e., regulatory, translational, biostatistics, pharmacology/toxicology) to allow efficient execution of clinical studies.

  • Works collaboratively with external project leaders to initiate clinical studies based on sound scientific rationale and clearly defined endpoints

  • Able to work independently as well as contribute as part of an interdisciplinary team

  • Maintain flexibility to meet deadlines and to respond to frequent and/or unexpected changes

  • Leads mentorship of newly hired clinical scientists

Job Requirements
 

  • BSN, MS, PhD or PharmD, or equivalent with clinical research experience. Advanced degree candidates preferred

  • A minimum of 10+ years' experience in the pharmaceutical industry, with a minimum 5-8 years clinical development/clinical operations experience in oncology

  • Requires thorough understanding of the drug development process from pre-IND through registration and post-registration

  • Broad and solid understanding of functional areas of drug development, including but not limited to, preclinical, clinical operations, regulatory, pharmacovigilance, drug supply, and biometrics (including biostatistics and data management

  • Candidates must possess highly effective communication skills, both written and verbal.

  • Ability to understand, interpret and communicate clinical information including literature reviews, competitive intelligence, and changing treatment paradigms in order to apply knowledge to support a robust overall clinical development strategy

  • Critical traits for success include strategic and proactive thinking, strong scientific and analytical skills, decisiveness and the ability to perform as a respected team member and leader

  • Ability to work independently and to organize priorities and deliverables

The candidate should be detail-oriented, a self- starter and be comfortable with broad responsibilities in an entrepreneurial, fast-paced, small company environment.
 

 

 

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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