Medical Director/Senior Scientific Director

*Preferred location is Lake County, IL but can sit remotely anywhere in the US.

*Position title will be based on qualifications listed below.

Provides specialist medical and scientific strategic and operational input into core 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 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.

Responsibilities:

• Initiates medical affairs activities, generation and dissemination of data supporting the overall scientific strategy.
• Responsible from Global Medical Affairs for the design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports and regulatory submissions and responses.
• Oversees the conduct of clinical trials and is medically and scientifically accountable for resolution of safety (AE’s & SAE’s) issues, interpretation of statistical analyses for clinical significance, PI selection, scientific documents reporting safety monitoring and other scientific reports submitted to the regulatory authorities.
• Co-lead and shape the Integrated Evidence Plan (IEP) including GAP assessment and the Scientific Communication Strategy (SCS) – Scientific Platform and Narrative and Scientific Publications Plan.
• Design, evaluate & execute various types of research ranging from clinical to RWE
• Rapidly gain and share insights on the evolving healthcare, guidelines and competitive landscape
• Lead congress and EE engagement mapping and planning.
• Post congress debriefs/insights and strategic implications which will impact asset vision, clinical development/study endpoints and strategic planning and governance.
• Guide TA related Medical Information activities (anticipating and plan for standard GMI responses, FAQs and Reactive Responses)
• Participation in design and execution of clinical trial safety, product safety and risk management plans. May also carry responsibility for routine and ad hoc safety monitoring reports to regulatory agencies. May review, assess and report applicable Adverse Events (AE’s) and Serious Adverse Events (SAE’s) if assigned to AbbVie conduct on clinical studies.
• Has overall responsibility for oversight of clinical studies, monitoring overall study integrity and review, interpretation and communication of accumulating data pertaining to safety and efficacy of the molecule. Along with Clinical Operations, is responsible for oversight of study enrollment and overall timelines for key deliverables.
• May 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.
• May interact with and coordinate appropriate scientific and medical activities with internal stakeholders (i.e., commercial, clinical operations, discovery, statistics, regulatory, etc…) as they relate to on-going medical affairs projects. Serves 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 the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements.
• Partner and upskill Area and Affiliate teams during Affiliate TouchPoint preparation and exchanges/deep dives.

Requirements

Senior Scientific Director Qualifications:

• Advanced Degree PhD or PharmD. Additional post doctorate experience highly preferred
• Typically, 10-15 years of experience in the pharmaceutical industry or equivalent; substantial understanding of relevant therapeutic area required.
• 7-10 years of experience in Medical Affairs with Global Medical Affairs experience highly preferred.
• Minimum of 4 years of clinical trials direct management experience in the pharmaceutical industry or academia or equivalent. 4+ years of experience is 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.
• Ability to run a clinical study independently with little supervision.

Preferable:

• Early phase drug development knowledge (PK/PD, Phase 1 planning and study design)
• Rheumatology Experience

Medical Director Qualifications:

• Medical Doctorate (M.D.) degree 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 is preferred.
• Minimum of 5 years of clinical trial or medical affairs experience in the pharmaceutical industry or academia or equivalent. 3+ years of experience is 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.
• Ability to run a clinical study independently with little supervision.
• Proven leadership skills in a 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.

Preferable:

• Early phase drug development knowledge (PK/PD, Phase 1 planning and study design)
• Rheumatology Experience
• Leadership behaviors
  • Pioneering and proactive spirit.
  • Comfortable with ambiguity and resilient during times of change.
  • High level of subject matter expertise balanced with scientific acumen, executive communication, diplomacy, listening skills and strategic thinking.
  • Flexible and adaptable to meet enterprise needs and priorities (puts the team first vs individual interests).
  • Growth and strategic mindset.
  • Strong problem-solving abilities and able to embrace tough challenges.
  • High level of cross functional teamwork and leadership, able to build relationships and rapport quickly both internally with Areas and Affiliates and externally with Experts.