Pharm-Olam, LLC

Senior / Executive Medical Director - Oncology

Job Locations US-TX-Houston | US | US-NC-Raleigh-Durham | CA
Job ID
2021-2631
Category
Medical Affairs & Pharmacovigilance

Overview

About Pharm-Olam, LLC:

 

Pharm-Olam, LLC is a mid-size Contract Research Organization (CRO) that has a massive global reach. We are a company that strives to deliver cost-effective, quick-to-market clinical services in today’s emerging marketplace. Pharm-Olam has one of the largest global footprints of any CRO today and we are committed to not only maintain our standard, but to continue to strengthen our presence even further. We offer a unique working environment with a global team culture, competitive salary and benefits package.

 

Summary:

Overall, the Senior / Executive Medical Director - Head of Oncology Center of Excellence is responsible for the management of Medical Monitors and Drug Safety Physicians at Pharm-Olam. Works with an international team of medical monitors and safety officers to ensure the medical/clinical integrity and quality of studies conducted by Pharm-Olam International are conducted in compliance with all applicable competent authority regulations and international Good Clinical Practices (GCP). Advises and assures investigators, project teams, and clients on safety issues arising from medicinal products, devices and study designs undertaken by POI. Reviews SAEs, SUSARs and AEs reports and writes safety narratives in accordance with all applicable competent authority regulations and ICH E2 reporting standards.  Ensures protocols, investigator’s brochures, clinical trial reports written by Pharm-Olam are appropriately reviewed and approved in accordance with Pharm-Olam’s SOPs and good medical practices. Works with internal team members, senior management and business development on issues and questions of any medical /clinical nature. In addition, acts as a head of Pharm-Olam Oncology Center of Excellence.

 

This is a full-time direct opportunity for an experienced Medical Director, with CRO / Oncology experience. Candidates can be located in the US or Canada and position can be remote based. #LI-Remote

Responsibilities

Medical Monitor and Pharmacovigilance Officer Responsibilities:

  • Oversee the safety aspects of assigned clinical trials managed by Pharm-Olam including adverse events, safety reporting and laboratory testing.  When appropriate, assist the Project Manager in discussions with clients on safety issues or concerns that may have arisen.
  • Prepares the Medical Monitoring and other relevant Plans for studies conducted by Pharm-Olam prior to the start of the study
  • Serves as the medical monitor contact in study protocols
  • Reviews IND safety narratives in accordance with FDA and ICH E2 reporting standards and oversees the processing of SAEs, SUSARs, etc. to clients and to regulatory agencies
  • Provide ongoing tutoring/medical education to DSOs (Drug Safety Officers), Regulatory, Clinical Operations personnel and other team members
  • Provides 24/7 monitoring coverage as required for the assigned protocols
  • Reviews and addresses all medical alerts setup for the safety of assigned projects
  • Reviews clinical laboratory data on selected studies for safety tends or signals detection
  • Assists clinical data management with MedDRA and WHO coding
  • Conducts the medical reviews of safety listings and clinical trial data in assigned studies
  • Assists by reviewing or writing safety section of a clinical study report (CSR) and other safety reports including post marketing reports (e.g., PSUR)
  • Reviews Investigational Brochures, protocols or other study-related documents produced by Pharm-Olam for accuracy, completeness and comprehension and to provide scientific input as needed
  • Assists in the set up and conduct of Data Safety Boards (DSMB, DMB or similar) as required by Pharm-Olam.
  • Assists with protocol interpretation and, as needed, contacts appropriate team members to ensure appropriateness of decisions arising from such interpretation
  • May advice and assist clients on product development, study designs, endpoint analyses and the feasibility of conducting Phase I to IV clinical trials in countries proposed by Pharm-Olam. Liaise with country managers and department heads at Pharm-Olam as needed to meet this task
  • With the assistance of the country manager, advises on federal and local laws, regulations or medical practices affecting the clinical trials managed by Pharm-Olam.  Where appropriate, maintains contact with various medical consultants
  • May provide therapeutic consultation in support of the scientific, medical and regulatory operations of the company, including medical assessments on a consultative basis for post marketing activities (e.g., product labelling, health hazard evaluations, etc.)
  • Provide direction to the medical writing personnel and activities of the company
  • Attends and participates in Investigators’ meeting and other committees, meetings as requested
  • Attends and presents at major therapeutic conferences and drug development conferences
  • Supports the company’s growth through finding new clients and developing existing accounts in Business Development
  • Preparation and delivery of PVG, various medical/scientific and therapeutic area training
  • Supports marketing and promoting the company through writing articles, conducting journal interviews, etc.
  • Prepares and delivers of PVG, various medical/scientific and therapeutic area training

Business Development:

  • Generates leads with new clients and source appropriate contacts to facilitate potential meetings and new business proposals.
  • Tracks opportunities for the Medical Affairs department so that Pharm-Olam is positioned to interact with clients at the appropriate moment.
  • Clarifies client’s RFPs and objectives to ensure that client’s needs are fully understood by Pharm-Olam BD and Contract, Proposals and Development teams in order that Pharm-Olam proposal offers value added solutions to clients needs.
  • Reviews and provides prompt feedback on written proposal drafts.

Oncology Center of Excellence:

  • Develops and leads fully integrated Oncology Ecosystem

Working relationship:

  • Typically reports to the Chief Medical Officer
  • Supervises and manages Medical Monitors and Drug Safety Physicians
  • Works with Clinical Research Associates, Project Managers, and ADPMs to support cooperative exchange of study and safety data
  • Assigns employees with appropriate experience to work on clinical studies in a specific indication (under ID CoE)
  • Works with Biostatistics, Data Management, Regulatory Affairs, Contracts, Proposals, and Development and Business Development oversee the safety aspects of assigned clinical trials managed by Pharm-Olam including adverse events, safety reporting and laboratory testing in consultation with the project manager.
  • When appropriate, assists the project manager in discussions with clients on safety issues or concerns that may have arisen.
  • Act as Line manager too more junior Medical Staff as needed

Qualifications

Medical Doctor or DO degree (having MSc degree, PhD degree or MD Specialization is advantageous)

Relevant Oncology background or substantial Oncology Clinical Research experience

At least 10 years of previous experience within a clinical research environment, preferably a CRO environment.

High level of Organizational and IT/technological skills

High level of interpersonal and presentation skills.

 

For Consideration

 

Please apply online at www.pharm-olam.com/careers

 

Pharm-Olam, LLC provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

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