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Reference Number: SK-DMAMA
Location: Western Boston, Massachusetts, United States

Director, Medical Affairs

 

My client is a fast-growing pharmaceutical company located in the western suburbs of Boston, MA.  They are creating innovative therapies that help transform people’s lives, while playing an increasingly active role in the future of global health.  They strive to contribute to society through innovative application of science and medicine for the betterment of healthcare worldwide.

 

Their culture is collaborative, very positive, high energy, enthusiastic people. It’s a culture where you can be noticed, advance, and make a difference, to the company, and to the patients they serve.  They are looking, not just for someone who can do the job today, but for someone who can grow to become one of their organization's future leaders.  If you are curious, passionate, and determined to make a difference, this could be the organization for you!

 

I am currently looking for a Director, Medical Affairs for my client.  This role will focus on a launch product in the Parkinson’s Disease space.

 

You:

  • MD preferred (will also consider PharmD or PhD with right experience)
  • Strongly prefer experience in Parkinson’s Disease (will consider other neuroscience experience if you have are a MD)
  • 5+ years pharma experience, including in medical affairs
  • Strong presentation and communication skills
  • Ability to interpret scientific data
  • Must be office based in the Boston, MA area
  • Ability and willingness to roll up your sleeves and get your hands dirty
  • Must be authorized to work for any employer without sponsorship

 

TITLE:                                    Director, Medical Affairs

REPORTS TO:                     Executive Medical Director, Therapeutic Products

RELO OFFERED:                Yes


The Director of Medical Affairs is responsible for all Medical Affairs activities related to therapeutic products during late stages of clinical development and after regulatory approval in US and will work under the supervision and guidance of the Senior/Executive Medical Director, Medical Affairs.

 

RESPONSIBILITIES:

 

  • Medical Affairs Life Cycle Management for individual products; preparation and management of Phase IV clinical trials, including protocol development, interaction with and supervision of CRO activity and medical supervision of clinical trials and results interpretation in collaboration with respective Clinical Development and Clinical Operations team; support and coordination of strategy for pharmacoeconomic and other outcomes-based research with HEOR team
  • Collaborative development and execution of comprehensive Scientific Communications and Publications plan for the brand(s) including preparation and submission of abstracts, presentation of posters and oral reports at scientific congresses and development of primary and secondary manuscripts in timely and efficient manner
  • Review and compliant management of initiation of investigator-initiated trial proposals, CME proposals and other grant applications
  • Medical review of promotional materials (PMRC)
  • Medical review of non-promotional materials (MSRC)
  • Development of medical strategy for MSL teams, including creation of proactive and reactive MSL materials for use in the field and education of MSLs on respective topics
  • Review and approval of brand specific materials developed by Medical Information (SRLs, FAQs, AMCP Dossier, responses to ad hoc requests for information and presentations, etc.)
  • Prepare medical materials for Sales Force training and executing related training activities
  • Collaborate with the Brand Marketing team to ensure alignment on overall business strategy and the medical affairs team within a matrix environment that may utilize outside contractors; previous experience working in a collaborative environment with commercial colleagues is needed
  • Maintain fiscal responsibility for Medical Affairs activities related to brand(s), develop and manage budget

 

REQUIREMENTS:

 

  • MD, DO, PhD, PharmD or equivalent
  • Experience required: 5-7 years
    • The good working knowledge of US drug development, regulatory requirements, and prior experience in dealing with the FDA, including DDMAC is preferred, but not required
    • Industry experience in the development of pharmaceuticals, and especially prior Medical Affairs experience, is needed
    • Specialty training and clinical experience in neurology and Parkinsons’ Disease would be highly desirable in a candidate
    • Experience in development of compounds in other therapeutic areas and at earlier developmental stages is a plus
  • Other requirements (licenses, certifications, specialized training, physical or mental abilities required)
    • Strong communication skills, both written and oral, including presentation and scientific writing ability, are essential
    • Scientific reasoning, ability to interpret scientific data, and basic understanding of statistics are mandatory
    • Sense of urgency to meet agreed upon timelines and obtain results is essential.
    • Excellent leadership and people management skills will be important considerations in candidate selection
    • Working knowledge of MS application software (Word, PowerPoint, Outlook, and Excel) is necessary
  • Confidential Data
    • All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential
  • Compliance
    • Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of the company are carried out with the "best" industry practices and the highest ethical standards.
  • Mental/Physical Requirements
    • Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary
    • Requires a high level of initiative and independence
    • Excellent written and oral communication skills required
    • Requires ability to use a computer for extended periods of time