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Senior Medical Director Consultant

Cambridge, MA

Posted: 11/08/2019 Employment Type: Contract Job Category: Clinical: Clinical Operations and Development Job Number: 2476

Job Description


Our client is seeking an experienced Senior Medical Director to play a key role in their Early Development Team. Working with cross-functional teams and external collaborators, the Senior Medical Director will take a leadership role in the creation and execution of early clinical development plans and in the development of strategies that will ultimately lead to global approvals of our client’ s products. This high-visibility role relates to the leading program in our client’ s Early Development portfolio.

To be successful in this role, the individual will be a creative, resourceful, integrative thinker who is selfmotivated, has a strong work ethic and operates with a high degree of professional integrity. Additionally,  the individual must be able to build relationships and influence decision-making while managing to prespecified  timelines. The candidate will be expected to thrive in the dynamic environment of a successful  and growing company and to develop positive collaborations with contract research organizations,  academic institutions, and nonprofit organizations.

Responsibilities:

For assigned programs…
  • Represents Medical Science on the Program Team as the Program Medical Lead. Accountable and responsible for the medical input to integrated development plans prepared by the Program Team and the clinical development plans that underpin them.
  • Leads the Clinical Sub Team of the Program Team. Accountable and responsible for driving the execution of the clinical development plan.
  • Accountable for the study design of clinical trials in Early Development, leading on the preparation of clinical study synopses and being a major contributor to the writing of protocols/major amendments, the design of data collection systems, interpretation of clinical data, and the preparation of final clinical study reports. Engages with external experts and organizations as needed to achieve these aims.
  • Key contributor to regulatory strategies and authors and/or reviews appropriate regulatory documents.
  • Accountable and responsible for the ongoing assessment of benefit/risk including support of adverse event reporting and safety management, under the direction of the DSPV function.

Desired Skills and Experience:
  • Medical degree and 5+ years broad bio/pharmaceutical industry experience in drug development
  • Knowledge of Neurology and/or Psychiatry; Phase 1 through launch. NDA and/or MAA experience strongly preferred.
  • Deep knowledge and understanding of the drug development process including technical, business, and regulatory issues.
  • The successful candidate must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient in that setting.
  • Must excel in a multidisciplinary environment as an integral leader and provide medical science leadership within assigned teams. Ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations is essential.
  • Excellent written and verbal communication skills, strong problem-solving ability, and attention to detail and quality are critical to success.
  • Diplomacy and professionalism, ‘ clicking’ easily with the company and leadership, with the foresight and savvy to contribute to the corporate goal of becoming a leader in CNS disorders and bringing medicines to patients.
  • Highly motivated, decisive and results-oriented individual with the flexibility and creativity to excel in and contribute to a rapidly growing company.
  • Able to command respect from peers and subordinates alike, capable of highly-independent work as well as being a team player and role model.
  • Able to effectively interface with clinical operations, regulatory, and other disciplines.
  • Excellent verbal and written skills, allowing for open and effective dialogue throughout the Company.
  • Proven ability to manage multiple projects, and proactively identify and resolve issues.
  • Ability to influence without authority, lead change and manage resistance to change.
  • Must be able to solicit information, persuade others and shape outcomes. Must have the passion and ability to forge and nurture key partnerships and collaborations with the external scientific community, including academia, governmental organizations, nonprofit organizations and CROs.

Meet Your Recruiter

Aaron Goldman
Clinical Recruitment Team Lead

Aaron is a spirited guy who likes to make things happen. He has been a Clinical Recruiter for the past five years, and says his greatest reward comes when a candidate accepts an offer and he hears the excitement in their voice - You know you have helped someone change their life!
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