Global Medical Indication Lead - Neurology (Als)

2+ years

Not Disclosed

Boston

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!

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Global Medical Indication Lead - Neurology (Als)

Job Description

Job Description:

Responsibilities:

Education, Experience, and Qualifications:

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