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Director of Clinical Affairs

  • LocationEast Windsor, NJ 08520 - United States
  • Work TypeFull time
  • Positions1 Position
  • Published At:4 days ago
  • Job no: 39983
  • Category: Clinical

Job Description


A leading company in the pharmaceutical industry is currently seeking a Director of Clinical Affairs to join their team. The role will be challenging but also highly rewarding and this leader will be a key voice in the company. For the right executive, this is a fantastic opportunity with great growth prospects. Key duties include:


1) Develop budgets for all clinical projects and adhere to company's financial goals

2) Manage CROs and other vendors to ensure clinical plans are met on time and under budget and develop appropriate infrastructure over time to manage the clinical trials more effectively

3) Develop therapeutic product profile for in-house and partnered products4) Oversee design of clinical trials, including protocol development, clinical trial discussions with regulatory authorities and development of timeline and budget

5) Manage the process of obtaining necessary clinical trial alignment and approvals from IRBs and regulatory bodies

6) Keep upto date on knowledge of current applicable international regulation and regulatory guidance, as well as in-depth product and clinical knowledge of indications

7) Provide oversight and assist the Medical Affairs Team on investigator-sponsored studies

8) Manage the process of screening, qualifying and selecting and contracting with CROs, investigators, sites and vendors required for conduct of clinical trial

9) Monitor CRO and vendors to ensure studies are on track for site initiation, patient recruitment and enrollment and take corrective actions where necessary to address issues

10) Ensure that clinical results are interpreted and documented clearly and concisely for regulatory submissions and publications

11) Maintain surveillance of published literature and clinical results for company and competitive products across all pertinent indications for strategic purposes and use in regulatory submissions

12) Spearhead and assist is due diligence of business development opportunities

13) Develop and manage collaborations with academic and community thought leaders, Clinical investigators and researchers to develop effective and efficient clinical programs

14) Develop SOPs and work instructions to ensure that internal and clinical study files conform to good clinical practice regulations and standards

15) Identify and develop clinical training materials for in-house and clinical site use

 

Critical Requirements


1) A university degree is required. Although all candidates are welcome and encouraged to apply, preference will be given to those with degrees in a relevant field

2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)

3) Recent experience in the pharmaceutical industry is strongly preferred

4) Preference will be given to candidates with recent experience in clinical affairs management


If you are qualified and looking to work with a well-established company – one of the top names in the industry – you should not let this opportunity pass by. However, for this Director of Clinical Affairs role, you must be someone who is experienced and passionate about clinical affairs management.


Compensation and Other Details


Base Salary: Highly competitive package, commensurate with experience

  • Published on 13 Jan 2022, 1:01 PM