This is a pharmaceutical company that focuses on discovering and developing new therapeutic drugs for the treatment of cancer and other critical diseases.
Position Title: Associate Director / Director / Senior Medical Director - Job #2111-5677
Therapeutic Area: Oncology
This description is for two open positions. The title will be dependent on professional years of experience.
The professional will serve as a primary medical lead for the Company’s clinical trials and will collaborate with cross-functional study teams on clinical trial strategies, design, and execution. Additionally, the professional will serve as the primary Medical Monitor and be responsible for monitoring the safety of enrolled subjects on assigned trials.
Essential Duties and Responsibilities
- Work on multiple trials in Phases 1 through 3.
- Participate in the development of Study Protocols, Investigator’s Brochures, Clinical Development Plans, and other key study documents in conjunction with other line functions and with minimal guidance.
- Serve on cross-functional teams for assigned trials, working with other team members to achieve efficient, high-quality study execution.
- Participate in the preparation of regulatory documents in support of regulatory submissions, including a clinical section of IND’s and CTA’s, IND safety reports and annual reports for assigned trials, responses to regulatory authorities and Ethics Committees/IRBs, and other documents as appropriate.
- Provide scientific and clinical input to study-related documents and analysis plans, including Informed consent forms (ICF), clinical research forms (CRF), statistical analysis plans (SAP), clinical pharmacology analysis plans (CPAP), and clinical study reports (CSR).
- Serve as a liaison between Clinical Development and other internal groups at the Company (e.g., Regulatory Affairs, Clinical Operations, Clinical Data Management) for assigned studies.
- Represent the Company to outside medical personnel in the development of clinical protocols and study conduct.
Qualifications (Education & Experience)
Note: In order to maintain a safe work environment, the Company requires all employees to be fully vaccinated against the Covid-19 virus at the time of employment.
- MD, DO, or equivalent ex-US medical degree (non-MD candidates with doctoral degrees may be considered if they have an appropriate background in a clinical field).
- Board certification/eligibility in Oncology is highly desired.
- Global clinical research experience and experience interacting with regulatory authorities is desired.
- Minimum of 5 years of clinical research experience in an academic or industrial setting, with experience in the analysis of research data and publications.
- Working knowledge of biostatistics and pharmacokinetics.
- Working knowledge of GCP, scientific, and clinical research methods, and clinical study design, and regulatory requirements for clinical studies.
- Pharmaceutical/Biotech industry experience, including time managing clinical trials and/or clinical development program(s) in the oncology field.
- Excellent oral and written communication skills.
- Ability to work collaboratively in a fast-paced, team-based matrix environment and can function independently as appropriate.
Since 2009, TriNet Pharma has evolved into one of healthcare’s largest and most respected agencies for recruiting and placing permanent and contract Medical Affairs, Clinical Operations, Regulatory Affairs, and Medical Communications professionals in life sciences companies in the United States and around the world.