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Sr. Medical Director, Medical Affairs

San Rafael, CA

Posted: 12/05/2018 Job Category: Clinical: Medical Affairs Job Number: 2211

2211 - Sr. Medical Director, Medical Affairs


Reporting to the Executive Medical Director, the Senior Medical Director position is a leadership role with substantial strategic input. The Senior 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.




Provide Medical Affairs Global Medical Product Leadership for post-marketing products:


•           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 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


Provide Medical Affairs Regional Medical Product Leadership for post-marketing products:


•           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 reginal 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


•           Provide Regional North American Leadership
  • Plan, structure, develop and grow MD and MSL capabilities to support product and Medical Affairs strategies in the region
  • Collaborate with other Medical Affairs heads of regions to develop and align on a shared global Medical Sciences strategy
  • Manage and resolve escalated issues and risks affecting the regional activities
  • Identify, initiate and lead functional improvement initiatives for the Medical Sciences function

•           May manage multiple levels of direct reports




•           MD with county licensure or fellowship required; BS in life or health sciences

•           5 or more years of relevant experience in clinical science, medical affairs, and/or drug development required

•           Rare Disease or Genetics knowledge/experience preferred

•           3 or more years of line management experience preferred

•           Ability to lead the regional Medical Sciences activities and Global product strategy, make impeccable decisions, and ensure the success of the business. To achieve these ends, the Senior Medical Director should:

•           Be a highly capable communicator to audiences of all types and sizes, modeling open and clear communication across functions and teams

•           Have a clear vision for the future of the business based on a big picture understanding of company strategy, and be able to effectively articulate this vision to others

•           Prioritize career development by inspiring and motivating others while proactively acknowledging the progress, growth and success of individuals and teams

•           Demonstrate mastery of the medical and scientific knowledge for key therapeutic areas

•           Be capable of making sound business decision considering corporate and product strategies and market realities

•           Be able to prioritize, establish and maintain key relationships with influential Key Opinion Leaders, HCPs and other industry thought leaders.

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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