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Medical Director - Women's Health

Reference Number: 2990
Location: IL

Our client is a leading pharmaceutical company. They have asked us to assist them in their search for a Medical Director – Women’s Health.

Major tasks and responsibilities will include:

  • Leads and demonstrates ownership of the design and implementation of multiple clinical development programs (or one large, complex program) in support of the overall product development plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, the company’s customers, markets, business operations, and emerging issues. Oversees project-related education of investigators, study site personnel, and the company’s study staff. Responsibilities may extend from early translational development activities to mature product lifecycle management strategies for internal and/or partnered programs.
  • Leads and mentors clinical study teams, monitors overall study integrity, and reviews, interpretations, and communications accumulating data pertaining to safety and efficacy of the molecule.  Along with Clinical Operations, is responsible for ensuring agreed-upon study enrollment and overall timelines for key deliverables.  Responsible for assessment and reporting of serious adverse events per corporate policy and regulations for those protocols on which assigned.
  • Has primary responsibility for and ownership of design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses, and other program documents.
  • Manages one level of Medical and Scientific Directors (typically 2 to 4) and/or Clinical Scientists.  This responsibility involves direct oversight of clinical development activities and/or management of personnel who may be working on other projects.  Responsible for hiring, onboarding, mentoring, training, and supporting career development of these individuals.
  • May chair Clinical Strategy Team(s), with responsibility for development of a rigorous, cross-functionally-aligned, vetted Clinical Development Plan with full consideration of contingencies and alternative approaches.  In this capacity, responsibilities may include supervision of matrix team members and serving as the Clinical Research representative to lend clinical development and medical expertise to Asset Development Teams (ADTs) and ADT Leadership Boards (ALBs), and other cross-functional teams and internal stakeholders.
  • Serves as the in-house clinical expert for one or more molecules and diseases in the therapeutic area, coordinating and leading appropriate scientific activities with internal stakeholders as they relate to ongoing projects.   Participates in or lead clinical development contributions to due diligence or other business development activity.  As required by program needs, contributes in partnership with Discovery colleagues to design and implementation of translational strategies.
  • Acts as clinical lead and actively solicits opinion leader interactions related to the disease areas; partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate.
  • Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area.  May represent the company at key external meetings.
  • Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as a clinical representative for key regulatory discussions.
  • Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research. 

We seek candidates with the following qualifications:

  • MD or DO degree with relevant therapeutic specialty in an academic or hospital environment required. Completion of a residency program strongly preferred.  Completion of a subspecialty fellowship is desirable.
  • At least 7 years of clinical trial experience in the pharmaceutical industry.
  • Ability to run a complex clinical research program independently, interpret data, interact with regulatory authorities and review and oversee regulatory submission along with Executive Medical Director.
  • Proven leadership skills and has the ability to bring out the best in others on a cross-functional global team.  Must be able to lead and manage through influence.
  • Uses best judgment to assure that junior-level staff works with an appropriate level of autonomy and demonstrates commitment to training and development.
  • Ability to interact both externally and internally to support global scientific and business strategy.
  • Extensive knowledge of clinical trial methodology, regulatory and compliance requirements, knows how to govern clinical trials, experience in development of clinical strategy and the design of study protocols.
  • Ability to exercise judgment, address complex problems and create solutions across multiple projects.

 

Do you have the skills and experience we seek and want to advance your career with one of the world’s leading companies? If so, please email your resume as a Word attachment to us, reference 2990. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.