Medical Director or Scientific Director, Medical Affairs Global Oncology Pipeline

Job Description

Purpose:

Provides specialist medical and scientific strategic and operational input into core medical affairs activities such as healthcare 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 clinical development teams to support trial enrollment and evidence generation. Also works closely with commercial teams to provide strategic medical input into core brand product strategies and to support marketing activities promotional material generation and product launches and market access.

Responsibilities:

1. Generate and lead Medical Affairs strategies for GI oncology pipeline.
2. Initiates medical affairs activities generation and dissemination of data supporting the overall scientific strategy.
3. Contributes to the development of brand strategies.
4. Generates clinical and scientific data per evidence gap assessment.
5. Aligns Medical education and scientific initiatives with Sci Comm Platform.
6. Participates in the externally sponsored studies review and recommendations for approval for assets under his/her responsibility.
7. Contributes to the development of and leads the execution of the Medical Education / Advisory Board & EE Engagement Plan generation in line with TA plan. May lead Conference planning and execution.
8. Contributes to the generation of MI communication content and supports training on Medical Information MI materials.
9. Develops and executes Medical Affairs support of priority clinical development trials.
10. Responsible for the design analysis interpretation and reporting of scientific content of protocols Investigator Brochures Clinical Study Reports and regulatory submissions and responses.
11. May oversee 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.
12. May participate 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.
13. 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.
14. 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.
15. 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.
16. Ensures budgets timelines compliance requirements are factored into programs' scientific activities.
17. Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements.

Qualifications

Medical Director

1. 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.
2. 3 years of experience in the pharmaceutical industry or equivalent.
3. Minimum of 2 years of clinical trial or medical affairs experience in the pharmaceutical industry or academia or equivalent with Global Medical Affairs experience highly preferred.

Scientific Director

1. Advanced Degree PhD or PharmD. Additional postdoctorate experience highly preferred.
2. 10 years of experience in the pharmaceutical industry or equivalent.
3. Minimum of 5 years of clinical trial or medical affairs experience in the pharmaceutical industry or academia or equivalent with Global Medical Affairs experience highly preferred.

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 401k to eligible employees. This job is eligible to participate in our short-term incentive programs. This job is eligible to participate in our long-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 paid and may be modified at the Company's sole and absolute discretion consistent with applicable law.