Job DescriptionThe Scientific Director / Senior Medical Director provides specialist medical and scientific input into core strategic and operational medical affairs activities such as: health-care professional and provider interactions; generation of clinical and scientific data (enhancing therapeutic benefit and value); educational initiatives (medical education, scientific communications, and value proposition) and safeguarding patient safety (risk minimization activities and safety surveillance activities). Works closely with sales, marketing, and commercial teams to provide strategic medical input into core brand (product) strategies, and to support medical affairs, marketing activities (promotional material generation and product launches) and market access.
This position is ideally based from our Mettawa, IL or Florham Park, NJ sites but other U.S. sites may be considered. Must follow a hybrid schedule of 3 days/week onsite.
Key Responsibilities:- Initiates medical affairs activities including data generation and dissemination strategy, development of Global Medical Affairs strategy, delivering the Medical Functional Plan, Brand Plan and working with Area and Affiliates to ensure execution of strategy.
- 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 oversight of the Medical Affairs-led clinical studies, monitoring overall study integrity 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 projects.
- M.D.s may participate in design and execution of clinical trial safety; scientifically accountable for resolution of safety issues, safety monitoring, and other scientific reports reported to regulatory authorities. Review and assess all Adverse Events (AE's) and Serious Adverse Events (SAE's).
- Acts as a clinical interface and actively solicits opinion through leader interactions related to the molecule and disease area; partners with Medical Affairs, Commercial 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.
- Interact with and coordinates appropriate scientific and medical activities with internal stakeholders (i.e., commercial, market access, HEOR, clinical operations, clinical development, regulatory, etc...) as they relate to on-going medical affairs projects. Serve as the scientific team interface for key regulatory discussions.
- Provide scientific/medical education to investigators, clinical monitors, and Global Project Team members related to therapeutic area or disease specific information. Keeps abreast of professional information and technology through conferences and/or medical literature and acts as a therapeutic area resource.
- Ensures budgets, timelines, compliance requirements are factored into programs' scientific activities.
- Responsible for understanding regulatory requirements related to clinical studies and global drug development and accountable for complying with those requirements.
QualificationsExperience Requirements Position will be commensurate with experience.
Scientific Director
- Advanced Degree PhD or PharmD. Additional post doctorate experience highly preferred.
- Typically, 10-15 years of experience in the pharmaceutical industry or related.
- 7-10 years of experience in Medical Affairs with Global Medical Affairs experience highly preferred.
Senior Medical Director
- Medical Doctorate (M.D.) or equivalent (D.O. or non-US equivalent of M.D.). Relevant therapeutic specialty in an academic 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.
Qualifications:- Substantial understanding of relevant therapeutic area required. Direct 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 strategy and the design of protocols.
- Proven leadership skills in cross-functional global team environment
- Ability to interact externally and internally to support global business strategy
- Must possess excellent oral and written English communication skills
Additional InformationApplicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this postingbased on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more orless than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our short-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission,incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paidand may be modified at the Company's sole and absolute discretion, consistent with applicable law.
