Senior Medical Director Medical Affairs - OncologyElahere REMOTE

The Senior Medical Director provides specialist medical/scientific strategic and operational input into core medical affairs activities within the designated therapeutic area. This will include healthcare professional/provider interactions; generation of clinical and scientific data; educational initiatives (medical education data guidelines and value proposition); safeguarding patient safety (risk minimization activities / safety surveillance activities).  Works closely with sales marketing and commercial teams to provide strategic medical input into core brand strategies and to support medical/marketing activities and market access. Provides scientific and technical support for assigned products; delivers scientific presentations; develops and maintains professional and credible relationships with key opinion leaders; actively participates in relevant Brand Teams and helps develop medical affairs strategies for assigned products. Develops innovative research concepts for clinical data generation; provide relevant scientific and technical training. 

Responsibilities: 

• Establishes and approves scientific methods for hypotheses rationale design of affiliate/Area protocols and their reports across different products. 

• Oversees the conduct of clinical trials and is medically and scientifically accountable for resolution of safety issues interpretation of statistical analyses for clinical significance PI selection scientific documents reporting safety monitoring and other scientific reports submitted to the regulatory authorities.   

• Participation in design and execution of clinical trial safety product safety and risk management plans.  May also carry responsibility for safety monitoring reports to regulatory agencies. May review assess and report applicable Adverse Events and Serious Adverse Events if assigned to AbbVie conduct on clinical studies. 

• All clinical research / development activities for products under development and for post approval commitments such as regulatory agency mandated trials or those intended to support product registration or to generate data for label inclusion remain the primary responsibility of TA development teams. 

• Drives medical affairs activities and generation and dissemination of data supporting overall product scientific and business strategy.  Coordinates induction mentoring training and development.  Identifies training needs. 

• Interacts with and coordinates appropriate scientific and medical activities with internal stakeholders (i.e. commercial clinical operations discovery statistics regulatory etc) as they relate to ongoing medical affairs projects. May develop scientifically accurate marketing materials medical education programs advisories and symposia. 

• Oversees scientific/medical education of investigators clinical monitors and 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. 

• Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as the scientific team interface for key regulatory discussions. Represents AbbVie at external meetings including investigator meetings scientific association meetings etc. 

• Assists with the scientific review development approval execution and communication of affiliate/area medical affairs sponsored or supported clinical research activities. May lead cross functional teams in development and execution of strategic initiatives requiring integration of multiple subprojects within the therapeutic area or Medical Affairs function. 

• Ensures budgets timelines compliance requirements are factored into programs scientific activities. Works independently. Can address complex problems within discipline or across several projects. Exercises judgment within broadly defined practices and policies in selecting methods and techniques for obtaining solutions. Works on complex problems in which analysis of situation or data requires an indepth evaluation of various complex factors.  

Qualifications :

• Medical Doctorate (M.D.) degree or equivalent (D.O. or nonUS equivalent of M.D. with relevant therapeutic specialty in an academic or hospital environment.  Completion of residency and/or fellowship is preferred . National license to practice medicine preferred..)   

• Minimum of 5 years of clinical trial experience in the biotech/ pharmaceutical industry or academia or equivalent.  7 years of experience is preferred. 

• Proven leadership skills in a crossfunctional team environment. People management experience preferred.  

• Ability to run a clinical program or medical affairs team(s) independently with little supervision. 

• Extensive knowledge of clinical trial methodology regulatory requirements governing clinical trials and experience in developmental strategy and the protocols. 

• Expert knowledge in a relevant therapeutic specialty. Experience in a senior role in a TA preferred. 

• Must have an understanding of the Pharmacovigilance practices for Clinical Development programs. 

• Must have an indepth understanding of the Clinical Development process for Phase IIV or extensive knowledge of Pharmaceutical Development including compliance and regulatory requirements. Must possess excellent oral and written English communication skills. Ability to interact externally and internally to support business strategy. International experience is a plus. 

Additional Information :

Applicable 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 posting based 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 or less 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 shortterm incentive programs. 

• This job is eligible to participate in our longterm 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 Companys sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable law. 

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives serving our community and embracing diversity and inclusion.  It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race color religion national origin age sex (including pregnancy) physical or mental disability medical condition genetic information gender identity or expression sexual orientation marital status status as a protected veteran or any other legally protected group status.

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