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Medical Director, Medical Affairs

San Francisco Bay Area, CA

Posted: 11/12/2018 Job Category: Clinical: Medical Affairs Job Number: 2209

Reporting to the Executive Medical Director, the Medical Director position is a leadership role with substantial strategic input. The Medical Director may be assigned global or regional product responsibility with a focus on shaping and defining the strategy and tactics required to support medical affairs product pipeline, launch and post-marketing commitments. Key product responsibilities include cross-functional leadership, strategic alignment with commercial business partners, product launch strategy and execution, scientific message development and product scientific materials review, KOL relationship management and medical monitoring of post-approval commitments.

RESPONSIBILITIES INCLUDE:
  • Global Product Strategy & Execution
    • As a Global Product Medical Lead, develop and communicate Global Medical Plan in collaboration with Medical Affairs stakeholders
    • Act as product and disease area expert and primary contact point for all global compound or disease area related issues both from within Medical Affairs and all other departments
    • Identify, develop and maintain the scientific messaging platform with Medical Communications and other relevant stakeholders
    • Conduct critical appraisal of available scientific and medical knowledge, identify gaps and identify and lead activities to address deficiencies
    • Review and approve all product materials (dossiers, medical Information response documents, slide decks, etc.)
    • Drive scientific messaging and gap analysis as well as communications regarding product or disease area
    • Contribute to the development of, and review and approve global publication plans
  • Cross Functional Leadership
    • Act as the Medical Affairs representative on key cross-functional product and development strategic focused teams
    • Lead the Medical Affairs cross-functional Product Team
    • Represent Medical Affairs on relevant commercial teams: Launch Team, and Global Brand Teams for marketed products
  • Market relationship and Access Development
    • Manage contact with global KOLs, particularly for Pipeline products, ensure appropriate access to KOLs during entire product lifecycle
    • Provide oversight for international symposiums, advisory boards, manuscripts
  • Product Launch
    • Develop Medical Affairs global product launch strategy and roadmap and lead all Medical Affairs global launch activities in collaboration with Commercial and other key stakeholders
  • Filing / Regulatory
    • Assist in writing medical need, natural history and risk/benefit sections of BLA and MAA
    • Represent Medical Affairs at FDA/EMA advisory board meetings
  • Post Marketing – Registries, IR, Observational
    • Lead for development/design of global PMC/PMRs and studies falling under Medical Affairs scope in coordination with Medical Affairs Study management
    • Act as medical monitor for global PMR/PMC and studies falling under the Medical Affairs scope in collaboration with Medical Affairs Study management
    • Oversee clinical registries and evaluate safety issues associated with products and promotional activities for products in accordance with respected regulatory requirements
    • Assist in critically evaluating study results in statistical and final reports and ongoing reviews with study investigators, resolving problems arising during clinical investigations and preparing reports to the management and medical community
    • In collaboration with Regional Medical Product leadership and Area Medical Leads, conduct critical scientific and medical review of IR protocols
  • Training
    • Support early disease training across the company. In collaboration with Medical Affairs learning and development department develop content and modules for training

 
  • Product Strategy & Planning
  • Develop and implement the Regional Medical Plans and lead regional medical activities in coordination Medical Affairs, Commercial and Regulatory colleagues
  • Ensure adherence to regional regulatory and clinical practice guidelines in supporting development and marketing of compounds
  • Act as single point of contact and product and disease area expert for all product or disease area related issues from within the assigned region
  • Scientific Messaging and Product Marketing Materials
  • Lead the creation of a localized scientific messaging platform and related regional launch materials, response letters
  • Drive regionally relevant publications on diagnostics, disease management and treatment guidelines and attend quarterly publication meetings
  • Review Medical Information request fulfillment, standard response documents and FAQs in local language with sign-off responsibility where regulations require
  • Conduct medical review of promotional material to ensure maximum effectiveness while adhering to the company' s ethical standards and relevant Codes of Practice for the region
  • Participate in, and contribute regional perspectives to scientific messaging discussions
  • Local Market Key Relationship and Access Development
  • Communicate with regional commercial team on a regular basis to ensure appropriate medical/scientific support for marketing and sales initiatives in the region
  • Develop, manage and maintain key regional KOL relationships in close collaboration with other MDs or MSL teams
  • Organize, attend, and if required, chair regional advisory boards
  • Product Launch
  • Develop regional launch plans in collaboration with Medical Affairs and Commercial colleagues and execute on the Medical Affairs tactical launch activities in region in support of global product launch
  • Post Marketing – Registries, IR, observational
  • Act as Medical Monitor for regional PMC/PMRs and studies falling under the Medical Affairs scope in collaboration with study management lead when required; Assist study management team in medical review and input in Medical Affairs-run studies in the region
  • Attend regional investigator meetings, as needed in alignment with Regional Medical Plan objectives
  • Oversee Independent Research Program in the region and ensure activities undertaken are in line with Regional Medical Plan
  • Product and Disease Training and Education
  • Assist in the training of new commercial recruits by presenting the scientific disease and product related data and present at sales conferences, regional meetings, etc. to develop high level of medical knowledge within sales force

REQUIREMENTS / QUALIFICATIONS:
  • MD with country licensure or fellowship required; BS in life or health sciences
  • Rare Disease or Genetics knowledge/experience ideal
  • 3 or more years of relevant experience in clinical science, medical affairs, and/or drug development desired
  • Mastery-level understanding of multiple competencies, including communication and medical and scientific knowledge
  • Advanced skills in strategic thinking, problem solving, business acumen and drug development, regulatory and study design.
  • Be recognized as a highly capable facilitator of information sharing across all levels of the organization
  • Actively foster and maintain product strategy working relationships with key influential stakeholders
  • Demonstrate deep medical and scientific knowledge for key therapeutic areas
  • Demonstrate solid understanding of cross-functional interdependencies across the drug development lifecycle
  • Have ability to design studies and develop protocols in a wide range of types of study phases pre- and post-marketing

Tracey Goldthwaite
Senior Vice President

Tracey has more than 20 years experience in the staffing and recruiting industry. She spearheads The Steely Group's Client Services efforts, ensuring superior customer service, communication, and ongoing support to clients and candidates alike. Additional areas of expertise include client relationship management and team building.
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