Executive Director, Clinical Programs

  • Job posted by Cohen Veterans Bioscience

Job Type

Full Time

Published

10/10/2018

Address

311 West 43rd Street
New York
New York
10036
United States

Description

Executive Director, Clinical Programs

Cohen Veterans Bioscience (CVB) is looking for an experienced full-time Executive Director, Clinical Programs to work from our NY City office (311 W 43rd St) to act as a key leader supporting strategy and operational implementation of all CVB clinical trial-related activities, including CVB-sponsored clinical trial programs and supporting collaborative research programs de-risking potential Partner products at different stages of development. This position will report to the Chief Medical Officer.


This position will involve extensive coordination with internal cross-departmental functions (Biostatistics, Biomarkers, Information and Data Science, Strategic Roadmapping, Regulatory Affairs, Quality Assurance, Operations), external CROs, clinical networks and subject matter experts, as well as management and development of clinical operations personnel.


Responsibilities


Day-to-day responsibilities will include direct oversight of the clinical trial programs, with a focus on protocol development, clinical operations, and interactions with CROs and subject matter experts. Specifically, the Executive Director will:

  • Ensure the appropriate communication and reporting of trial related activities and metrics to the organization
  • Establish relationships with a network of SMEs across a wide range of functions including preclinical, toxicology, biometrics, safety, regulatory affairs, quality assurance, and a variety of business functions, as well as various disease experts
  • Develop and lead discussion and workshops with external SMEs or advisory committees around protocol design, study implementation, recruitment strategies, safety oversight, analytical plans, and regulatory strategy
  • Participate in trial support vendor selection
  • Interview and make recommendation on CRO staff, including monitors, project managers, and medical monitor
  • Establish realistic team work flows based on project timelines
  • Develop and implement mitigation plans proactively
  • Develop conflict resolution and escalation plans for working with external vendors
  • Present at Investigator Meetings, assist with approve team presentation materials
  • Support regulatory document development, communications, and filing activities
  • Provide direction and mentorship to staff including setting goals that are aligned with both Corporate and project goals
  • Maintain inspection readiness across all clinical programs recommend and help establish clinical trial systems and processes, including documentation, QA, partnerships with CROs, investigator sites and physicians
  • Participate in the development and implementation of other key organizational process improvement initiatives


Additional Responsibilities may include:

  • Participating in due diligence of potential collaborative research programs with CMO
  • Managing development plans of multiple clinical trials with multiple external Partners at all stages of clinical development with novel and repurposed small molecules, cellular therapies, and devices for brain disordersMonthly domestic travel may be required for face to face interactions with the CVB team and/or partners at project start-up and close-out periods.


Qualification

  • Advanced degree (MD or PhD) required
  • Extensive experience, at least 5-8 years in drug development within the biopharmaceutical industry, preferably in Neurology and Psychiatry
  • Prior Management Experience (direct or in a matrix environment) of at least 3-5 years
  • Advanced understanding of drug development principles and clinical trial implementation and management.
  • Working knowledge of associated disciplines, including biostatistics, data management, and medical writing.
  • Complete understanding of US regulatory requirements for drugs
  • Working knowledge of US regulatory requirements for devices
  • Strong project management skills
  • Experience conducting clinical trials leveraging the resources of a CRO and multiple other vendors
  • Prior experience developing, managing, and working within departmental and project budgets
  • Leadership with strong results orientation
  • Ability to work on and solve complex problems.
  • Ability to prioritize and handle multiple tasks simultaneously.
  • Proven ability to foster team productivity, cohesiveness, and collaboration.
  • Excellent communication/interaction skills and experience in a dynamic and growing organization.
  • Ability to build relationships outside of the organization, cross-functionally and across geographic locations
  • Candidates with prior experience with in-licensing evaluations, development of products with multiple corporate partners, or alliance management experience is a plus.
  • Highly professional and capable of representing CVB to external partners and experts


About CVB

Cohen Veterans Bioscience is a national, nonpartisan research 501(c)(3) organization dedicated to fast-tracking the development of diagnostic tests and personalized therapeutics for the millions of veterans and civilians who suffer the devastating effects of trauma-related and other brain disorders.


To Apply

We offer a highly competitive salary commensurate with experience and a full benefit package.


Please visit https://cohenveteransbioscience.applicantpro.com to apply. Please include resume, cover letter, and salary requirements. CVB is an Equal Opportunity Employer. 

Professional Level

Managerial

Minimum Education Required

4-year degree

How To Apply

https://cohenveteransbioscience.applicantpro.com

To Apply

We offer a highly competitive salary commensurate with experience and a full benefit package.


Please visit https://cohenveteransbioscience.applicantpro.com to apply. Please include resume, cover letter, and salary requirements. CVB is an Equal Opportunity Employer.


Share:

Share: