Director, Medical Affairs

Employer
Location
Princeton, New Jersey (US)
Salary
Competitive salary and benefits
Posted
May 28, 2018
Closes
Jul 28, 2018
Position
Medical Director
Education
MD, PHD
Hours
Full Time

Director, Medical Affairs

Manages across a global matrix organization to drive quality planning and timely communication of key scientific/clinical information for Genmab products within Oncology. A key element of this role will be to motivate, drive and encourage collaborating coauthors and internal resources towards successful publications. Serves as a therapy area and product expert for both internal and external customers. Conducts medical review to ensure medical accuracy, currency and scientific-balance of promotional and medical communications materials produced by internal business partners.

 Develop and execute the overall medical strategy for designated products and therapeutic area

• Serve on Global Clinical Development Team as Medical Affairs representative

• Help identify and effectively interact with key thought leaders, patient advocacy groups and institutions to engage in scientific and medical exchange to meet the needs of patients and advance the field of study

• Serve as the medical lead on lifecycle strategy, including evidence generation strategy development and execution of Phase 3b/4 studies

• Assure appropriate close coordination with commercial and marketing teams to support their efforts, including medical expert support of product launches

• Collaborate with the field/regional team and support reactive material develop to address their healthcare provider questions

• Evaluate and manage Investigator Sponsored Trial efforts, including review of protocols and ongoing safety evaluations

• Collaborate with medical information specialists on the development of medical information letters and documents

• Coordinate with clinical and translational medicine teams on strategic priorities and study support

Key Accountabilities

• Collaborate with medical communications on the preparation of manuscripts, abstracts and presentations for scientific meetings as well as other scientific communications initiatives

• Contribute to the development of (and updates to) the yearly global publications plan for assigned product(s) and ensures optimal execution of plan

• Contribute to the development of internal guidance and resource documents

• Provide guidance in the development of strategies to demonstrate the value of disease/products within the medical affairs with a focus on outcomes meaningful to payer and clinical decision-makers

• Participates in medical review of branded and unbranded promotional materials, market access and health economics and outcomes research (HEOR) materials and medical communications materials to ensure accuracy, currency, scientific balance and compliance with internal policies and procedures.

• Develops expert understanding of disease state and current medical and/or regulatory issues related to company products. Contributes to therapeutic expertise during protocol design phase

• Ensure that key data, strategically aligned scientific communication points, elements from other internal guidance and resource documents are included appropriately in publications, and that statements and conclusions are accurate, balanced, and supported by appropriate data

• Participate in relevant cross-functional teams and task forces to represent the Global Medical Affairs team as needed. Make presentations to colleagues and senior management as needed

• Participates in discussions regarding the creation of departmental SOPs addressing processes and procedures necessary to achieve organizational objectives and for complying with government regulations and company policy. Ensures adherence to policies/procedures.

Skills & Experience

• Scientific or Medical Degree (Pharm D, PhD, MD) required

• Minimum 5 years of pharmaceutical industry experience required in the Oncology therapeutic area

• Extensive experience and strong understanding of oncology drug development and medical affairs is required

• Strong leadership presence and the ability to work effectively with other clinical and scientific leaders

• Demonstrated ability to lead strategically, drive performance, build alignment, inform, negotiate and collaborate

• Knowledge of pharmaceutical industry laws, regulations, and guidelines regarding medical education and publications

• Ability to formulate (write) strategic, long-range plans that are aligned with strategies across the organization and to implement them successfully

• Ability to work with multidisciplinary teams

• Flexible, with positive attitude, strong ability to multi task, prioritize projects effectively and communicate at all levels within the company

• Travel-up to 25% domestic and international

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