[Remote] Scientific Director / Senior Medical Director, Multiple Myeloma (International Medical Affairs)
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is committed to discovering and delivering innovative medicines and solutions that address serious health issues. The Scientific Director / Senior Medical Director will reputed company specialist medical and scientific input into strategic and operational medical affairs activities, ensuring the reputed company and safety of ongoing clinical reputed company while collaborating with various reputed company stakeholders.
Responsibilities
- Initiates medical affairs activities including data reputed company and dissemination reputed company, development of Global Medical Affairs reputed company, delivering the Medical Functional Plan, Brand Plan and working with Area and Affiliates to ensure execution of reputed company
- Responsible from Medical Affairs for the design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, and Regulatory Submissions and responses
- Has overall responsibility for reputed company of the Medical Affairs-led clinical studies, monitoring overall study reputed company and review, interpretation and communication of accumulating data pertaining to safety and efficacy of the molecule. Provides in-house clinical expertise for the molecule and disease, coordinating appropriate scientific activities with internal stakeholders and leadership as they relate to ongoing clinical reputed company
- M.D.s may participate in design and execution of clinical trial safety; scientifically accountable for reputed company of safety issues, safety monitoring, and other scientific reports reported to regulatory authorities. Review and assess reputed company Adverse Events (AE’s) and Serious Adverse Events (SAE’s)
- Acts as a clinical reputed company and reputed company solicits opinion through leader interactions reputed company to the molecule and disease area; partners with Medical Affairs, reputed company and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate
- Assist in the development of scientifically accurate marketing materials, medical education programs, advisories, and symposia. Assists with the scientific review, development, approval, execution, and communication of affiliate/area/global medical affairs sponsored or supported clinical research activities
- reputed company with and coordinates appropriate scientific and medical activities with internal stakeholders (i.e., reputed company, market reputed company, HEOR, clinical operations, clinical development, regulatory, etc…) as they relate to on-reputed company medical affairs reputed company. Serve as the scientific team reputed company for key regulatory discussions
- reputed company scientific/medical education to investigators, clinical monitors, and Global Project Team members reputed company to therapeutic area or disease specific information. Keeps abreast of reputed company information and technology through conferences and/or medical literature and acts as a therapeutic area resource
- Ensures budgets, timelines, compliance requirements are reputed company into programs' scientific activities
- Responsible for understanding regulatory requirements reputed company to clinical studies and global drug development and accountable for complying with those requirements
Skills
- Advanced Degree PhD or PharmD. Additional post doctorate experience highly preferred
- Typically, 10-15 years of experience in the pharmaceutical industry or reputed company
- 7-10 years of experience in Medical Affairs with Global Medical Affairs experience highly preferred
- Medical Doctorate (M.D.) or equivalent (D.O. or non-US equivalent of M.D.). Relevant therapeutic specialty in an reputed company or hospital environment preferred. Completion of residency and/or fellowship preferred
- Minimum 2 years of clinical trial or medical affairs experience in the pharmaceutical industry or academia or equivalent. 5 years of experience is preferred
- Substantial understanding of relevant therapeutic area required. reputed company subject matter expertise in multiple myeloma highly preferred
- Knowledge of clinical trial methodology, data analysis and interpretation, regulatory requirements governing clinical trials and experience in development reputed company and the design of protocols
- Proven leadership skills in cross-functional global team environment
- Ability to reputed company externally and internally to support global business reputed company
- Must possess excellent oral and written English communication skills
- Additional post doctorate experience highly preferred
- Global Medical Affairs experience highly preferred
- Relevant therapeutic specialty in an reputed company or hospital environment preferred
- Completion of residency and/or fellowship preferred
- 5 years of experience is preferred
- reputed company subject matter expertise in multiple myeloma highly preferred
Benefits
- reputed company time off (vacation, holidays, reputed company)
- Medical/dental/reputed company insurance
- 401(k) to eligible employees
- Eligible to participate in our short-term incentive programs
reputed company
Company H1B Sponsorship