AMD Global Medical Strategy

Proclinical is currently seeking an AMD for Global Medical Strategy for a Biopharmaceutical company located in Boston, MA. Successful candidate will provide medical support for the Cystic Fibrosis therapeutic area, and will be responsible for supporting development of the medical strategy and medical plan as well as executing against the medical plan.

Job Responsibilities:

• Support strategic alignment of the assigned clinical program/product working cross functionally and partnering with other key functions as outlined.
• Provide input and contribute to the global Therapeutic Area strategic imperatives, Medical Affairs objectives and annual brand tactical plans.
• Support development of Study Protocols, Life Cycle Management Plans and other key study documents in conjunction with other line functions and with limited guidance.
• Contribute towards medical interpretation of data for the assigned product(s).
• 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), and clinical study reports (CSR).
• Work with the Global Communications team to support development and execution of aligned strategies/tactics for maximizing our scientific communication efforts.
• Serve as promotional reviewer for global commercial pieces.
• Partner with global thought leaders to provide insights on current focused therapeutic area issues and questions.
• Support and executing Steering Committee meetings and advisory boards.
• Partner with external investigators on collaborative studies and with external registries on non-interventional studies using secondary data.
• Support review of investigator-initiated proposals and other research grants.
• Provide medical input and guidance to Early Access Programs and individual IND requests.

Skills and Requirements:

• MD, DO or equivalent ex-US medical degree (non-MD candidates with doctoral degrees may be considered if they have an appropriate professional background).
• Board certification/eligibility in pulmonary, gastrointestinal medicine, infectious diseases, or another relevant medical field, is highly desired; clinical Cystic Fibrosis experience is a plus.
• 3 - 5 years of experience in 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.
• Excellent oral and written communication skills.
• Ability to work collaboratively in a fast-paced, team-based matrix environment and to function independently as appropriate.
• Global clinical research experience and experience interacting with regulatory authorities is a plus.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Ella Jobson at (+1) 646-868-5142 or upload your resume on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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