Medical Affairs Associate Director

Actelion   •  

South San Francisco, CA

8 - 10 years

Posted 179 days ago

This job is no longer available.

Job Summary 

The Associate Director provides scientific and clinical guidance for Actelion US product initiatives. The AD is responsible for the medical monitoring of product Phase IV research program, supports the product Medical Team. and partner with Medical leadership in development of the annual medical plan and timely execution of medical tactics assigned to the role.

Job Responsibilities

Primary responsibilities include the following. Other duties may be assigned.

    • Function as a medical expert for Actelion products and provide expertise as needed within and outside the organization
    • Build strong relationships with key opinion leaders (KOLs) in the therapeutic area of interest and be committed to continuous scientific exchange with KOLs as appropriate in the field and during medical congresses
    • Act as the Medical Monitor for product Phase IV studies ensuring that clinical trials are conducted according to the investigational plan, regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as Actelion SOPs
    • Prepare study protocols, amendments, specific sections of study manuals and other documents as needed
    • Coordinate and implement ongoing data for internal analysis and review
      Coordinate the preparation and/or review of data listings, summary tables, study results, scientific presentations, and manuscripts for publication
      Develop product medical content for advisory boards and steering committees
    • Present scientific data at scientific conferences and other venues as needed
      Prepare scientific data for Medical Affairs team and/or Sr VP of Medical as needed for internal and external presentations
    • Develop and complete clinical study reports for Phase IV and other regulatory documents as needed
    • Provide medical and scientific feasibility for product medical projects
    • Development of medical and scientific materials when needed for purposes of medical education internally for relevant teams as well as for HCPs/KOLs externally
    • Work with Medical Director in development and timely execution of annual product Medical Plans, both strategic and tactical
    • Partner and serve as the Medical Lead for necessary cross-functional teams within Medical, such as Publications, Drug Safety, Medical Information, PRC, MRC; within brand team, such as ARC to support these teams from a medical perspective and maintain Actelion’s scientific leadership
    • Collaborate and communicate effectively with Global Medical, Life Cycle Team and other relevant teams in relation to assigned responsibilities and programs
    • Serve as the product medical conduit with Specialty Pharmacy in order to maintain medical relationship, provide product training and to provide medical guidance

Candidate Qualifications & Requirements

This job requires a combination of analytical, organizational and interpersonal skills. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  

Required

  • MD, PhD or PharmD with eight years relevant experience of which 5 years are pharmaceutical / biotech industry in medical affairs or clinical development, with strong medical focus and experience in regards to medical plans, publications, medical information, education grants, investigator initiated studies, and Phase IIIb/IV programs, or equivalent academic or clinical experience.

Preferred

  • MD, PhD or PharmD with eight years relevant experience of which 5 years are pharmaceutical / biotech industry in medical affairs or clinical development, with strong medical focus and experience in regards to medical plans, publications, medical information, education grants, investigator initiated studies, and Phase IIIb/IV programs, or equivalent academic or clinical experience.
    MD (cardiologist or pulmonologist)
  • Strong knowledge of PAH, pulmonary medicine and critical care
  • Strong communication and interpersonal skills
  • Medical science background with a strong understanding of clinical research and clinical trial design and management
  • Excellent interpersonal skills
  • Ability to form strong relationships based on credibility and trust, be able to work within teams and handle a fast-paced work environment
  • Ability to travel within and outside of the US as needed.

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