Sr. Director, Clinical Operations

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Sr. Director, Clinical Operations

Position Summary
We are looking for a hands-on trial manager with line management experience and  a proven track record in drug development.  Previous oncology experience is highly desired, as well as experience across all phases.  This person will direct all aspects of the clinical operations for identified program(s). This includes strategic and operational leadership relative to the direction, planning, execution, and interpretation of clinical programs and the data collection activities. Establishes and approves (with CRO, Program Executive or Clinical Managers) scientific methods for design and implementation of clinical protocols, data collection systems and final reports. May also have responsibility for partnered programs in the areas of supply training, labeling, package design & drug development. Overall responsibility for adherence to protocols. Interacts with various inside/outside groups to facilitate clinical programs. May select, develop, and evaluate personnel to ensure the efficient operation of the function.
Works on abstract problems across functional areas of the business. Identifies and evaluates fundamental issues for major functional areas through assessment of intangible variables. Interacts internally and externally with executive level management requiring negotiation of extremely difficult matters to influence policymaking. Participates in corporate development of methods, techniques and evaluation criteria for projects, programs and people. Responsible for the development and management of Clinical Development Plans (CDP) which includes timelines, budget, and resource requirements. Develops and implements clinical program strategy and directs those systems and programs in order to meet Company goals and objectives. Coordinates and directs outsourcing activities across program(s). Creates and directs program advisory committees as needed, such as Program Advisory Committee, DSMB and/or expert consultants.  Identifies program/resource gaps; devises and implements solutions. Provides weekly enrollment and program updates to senior management. Drives project risk analysis and develops solutions to a variety of complex problems.  Ensures that Clinical Operations department effectively interfaces with key functional groups. Remains current with medical developments and publications on similar and competitor products. Applies this knowledge to current programs. Mentors and develops Clinical Operations staff.  Directs internal staffing and performance management, including hiring, training, coaching and performance reviews.
A Bachelors/Masters degree in a scientific discipline is required. A PhD in a scientific discipline is preferred. Equivalent experience may be accepted. A minimum of 13 years Pharmaceutical development experience moving product candidates from Phase I through pivotal, with at least 5 years managing CROs is required.  A minimum of 10 years previous management experience may be required.
Must have a demonstrated ability to solve problems with innovative solutions along with strong organizational skills.  Excellent written and verbal communication skills are required. Previous experience working with senior management is required.  Experience and understanding of ICH, and GCP is required. Knowledge of GMP and GLP is preferred. Must be a demonstrated self-starter and team player with strong interpersonal skills. Must possess excellent project management skills. Must have strong computer skills with a proficiency in Microsoft Project, Word, Excel, Visio, and PowerPoint.

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rbenjamin's picture
February 13, 2012

February 13, 2012

Ref: Sr. Director, Clinical Operations

Dear HR Director,

In response to the above referenced position, I hereby attach a copy of my resume for your consideration.

I have over 20 years of eclectic leadership experience in drug development within a Pharmaceutical and Biologics industry, encompassing clinical operations, clinical program management and planning, clinical research and development, and post marketing studies. My experience runs the whole gamut - from clinical project planning, execution and management to NDA submission and Life-cycle management.

Summary of my experience includes:

Clinical Development Experience
? Design, Conduct and Reporting of Clinical Trials (phase 2, 3 & 4)
? CNS (3 NDA approvals)
? CVS (1 NDA approval)
o Lexxel: Fixed dose antihypertensive
? Oncology
o Orphan Drug status and Fast Track// phase 3, international HCC Program
o Phase 2 CRLM program
? Nephrology (Orphan Drug status and Fast Track//phase 3, international)
? Biologics: 1 BLA preparation for PCR testing of plasma

Clinical Operations
o SOP’s & guidelines
o Building-up the department infrastructure
o Budget forecasting for department
o Execution and Management of international clinical trials including site feasibility assessment and selection of sites
o Selection and management of CRO
? Developed scope of work, reviewed RFQs and negotiated budgets
? Wrote monitoring and communication plans

Clinical Program Management
o Project Planning, Execution and Management including feasibility studies for site selection
o Budgeting (HCC program for over $ 60m)
o Preparation, implementation and tracking of Project timelines
o Conflict resolution
o Risk assessment and contingency planning
o Tracking of study metrics
o Horizontal as well as vertical line of communication
o Computer skills: Use of MS Project (may need a refresher’s course for advanced use), MS PowerPoint, Word, Excel spreadsheet

Staffing, Training & Development
o Selection, training and management of CROs, scope development and budget negotiation.
o Staffing, training and development of direct reports (Clinical trial leads, clinical project managers, CRAs, clinical scientists) including reviews & performance appraisals.
? Job descriptions of direct reports
? Mentoring and coaching of new hires and optimal utilization of FTEs across all projects within a therapy area.

Over the course of my career, I have developed other essential skills such as adaptability/flexibility, oral and written communication skills, organizational skills, analytical and problem solving skills, interpersonal skills, negotiation skills, people management skills and effective team leadership within a matrix environment (data management, biostats, safety, Regulatory, Pharmacy operations etc) essential to getting the projects completed on-time, within budget and with quality data (meeting local Regulatory requirements and GCP-ICH guidelines).

My educational background (clinical pharmacy degree and an Executive MBA in Pharmaceutical R & D), successful track record and passion for delivering results makes me ideally suited for the position. It is my firm belief that, given the opportunity, I would make a significant and lasting contribution, leading to the growth of Clinical Development department.

I look forward to hearing from you at your earliest convenience.


Ronald S. Benjamin,
Cell: 410-440-3266