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Global Medical Indication Lead - Neurology (Als)

2+ years
Not Disclosed
10 Dec. 11, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Global Medical Indication Lead - ALS Clinical Development
Location: Boston, MA 02110
Employment Type: Direct Hire/Perm
Job Category: Clinical Development and Operations
Posted: 12/11/2024
Job Number: 616580
Remote: No
Country: United States

Job Description:

Planet Pharma is seeking a Global Medical Indication Lead for a key ALS indication within Clinical Development. This leadership role involves translating the Target Product Profile (TPP) into a comprehensive Clinical Development Plan, in collaboration with cross-functional teams, to ensure the successful development of the ALS treatment asset. The role will be based in Boston, MA, with frequent trips to the office and a preference for candidates in the EST time zone.

Responsibilities:

  • Lead the Clinical Development Plan (CDP) for the ALS indication, collaborating with cross-functional teams to answer critical questions and safeguard time, quality, and budget.
  • Provide continuous strategic medical insights for all stages of ALS treatment development.
  • Line management of the Global Clinical Trial Physicians working on the ALS indication, offering coaching and leadership to ensure high-quality medical support.
  • Oversee the medical aspects of studies, ensuring consistency and efficient communication with external stakeholders, such as IRBs and Regulatory Affairs.
  • Lead medical advisory boards as required for the ALS indication.
  • Ensure compliance and alignment across all ALS studies.

Education, Experience, and Qualifications:

  • Medical Doctor with a relevant specialty (Neurology/Neuromuscular, with ALS experience preferred).
  • 3-5 years of clinical development experience in the pharmaceutical or biotech industry, preferably with ALS experience.
  • Proven leadership and motivational skills, with experience in managing direct reports and leading through influence in a global, intercultural environment.
  • Expertise in clinical trial design, data interpretation, and strong communication skills.
  • Ability to travel and work within a matrix structure.

Apply Now:

To be part of a dynamic team working on pioneering ALS treatments, apply today!