Head, Clinical Operations - #1468

(Level may be Director, Sr. Director, or Executive Director)

Location:  Montgomery County Maryland


          *We offer a $1000 reward for successful referrals.  Contact us for details

          *We are conducting this search on an exclusive retained search basis

          *If relocation is necessary, assistance will be provided
          *Your start date may be in January if necessary
 

      Note:  We are also seeking candidates for a Clinical Trials Project Manager position with this same organization.   The Job description may be found by going to:  OncologySearch.com/1467
OUR CLIENT COMPANY

Our client company is a well-established clinical-stage T-cell focused biopharmaceutical company. Their leading drug candidate is uniquely positioned to address key unmet medical needs in immune-oncology and other diseases.   They are partnered with industry and academic leaders to investigate combinations with leading immunotherapeutics and to rapidly expand into additional combinations such as CAR-T.   They are well-funded and rapidly expanding.   We are assisting them in identifying qualified candidates for a Head of Clinical Operations on an exclusive, retained search, basis.

 
 
POSITION SUMMARY


The Director/Sr Director/Exe. Director, Clinical Operations will oversee all aspects of clinical trial operations including CRO/vendor selection, contract negotiation, and review and approval of invoice, managing drug supply forecast, developing appropriate SOPs to ensure trial conduction in compliance with regulatory requirements, and providing clinical operations related training to the clinical team. He/she will also be responsible for planning and determining resource needs, finalization of budgets and will work with Senior Management when input is necessary. This position reports to Vice President, Head of Clinical Development.

 
Responsibilities
  • Oversees all aspects of clinical operations and manages resources to ensure study milestones and deliverables are achieved.

  • Leads the overall operational aspects of clinical trials.

  • Ensures all programs under his/her oversight are conducted in accordance with applicable SOPS, ICH, GCP and other regulatory requirements.

  • Provides clinical support for required regulatory submission, such as annual reports, updating of the IB, and final study reports.

  • Develops departmental SOPs and works with Quality Assurance for compliance with applicable quality and regulatory requirements.

  • Provides routine updates regarding the status of programs to Senior Management.

Qualifications:

  • Experience in the management of Oncology trials or pediatric trials preferred but not required

  • Able to travel domestically (~ 5% or less, not applicable during COVID-19 pandemic)

  • Bachelor’s degree or equivalent is required (scientific or healthcare discipline preferred)

  • Experience in study coordination (e.g., study site) or study management (e.g., CRO or sponsor)

  • Fluency in study phases and demonstrable knowledge of how they apply to clinical development

  • Strong working knowledge of ICH Good Clinical Practice guidelines

  • Working knowledge of project management concepts (e.g., scope, resources, timeline, risk management)

  • Able to handle multiple tasks and deadlines

  • Must be self-motivating and able to work on problems of moderate scope and complexity where analysis of situations or data requires a review of a variety of factors

  • Able to identify issues and take appropriate actions

  • Highly effective verbal and written communication skills

  • Experience using computer applications including spreadsheets, email, word-processing software, and web-based systems

  • Experience in management of Oncology trials or pediatric trials preferred

  • Able to travel domestically (~ 5% or less, not applicable during COVID-19 pandemic)

  • Bachelor’s degree or equivalent is required (scientific or healthcare discipline preferred)

  • At least 1-2 years previous experience in study coordination (e.g., study site) or study management (e.g., CRO or sponsor)

  • Fluency in study phases and demonstrable knowledge of how they apply to clinical development

  • Strong working knowledge of ICH Good Clinical Practice guidelines

  • Working knowledge of project management concepts (e.g., scope, resources, timeline, risk management)

  • Able to handle multiple tasks and deadlines

  • Must be self-motivating and able to work on problems of moderate scope and complexity where analysis of situations or data requires a review of a variety of factors

  • Able to identify issues and take appropriate actions

  • Highly effective verbal and written communication skills

  • Experience using computer applications including spreadsheets, email, word-processing software, and web-based systems

Disclaimer:      

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.

Location: 

Montgomery County Maryland

Benefits

Benefits include but not limited to:  Health insurance (medical paid 100% by company), dental and vision), life insurance, and 401(k) with 1:1 matching up to 3% of the salary and 1:0.5 up to the next 2%.

Interested or have questions?

Please contact Steve Collins via email (Steve@OncologySearch.com) or phone (see contact information below).  Should you wish to schedule a conversation with Steve, please visit his call scheduler at:  https://calendly.com/steve4/call


Wish to make a confidential referral for this position or our recruiting services? (we offer a $1000 reward for each successful referral.   Contact us for details) 

There are two methods to make a referral;

  • Email us and provide contact information for the person you would like us to contact.  Your name will not be revealed without our receiving your approval in advance.

  • Provide our information (i.e. name, website, email address) to the person whom you feel may have an interest.   Please ask that person to mention your name when they contact us.

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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.

 

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