We are currently searching for a skilled professional to join a well-known client's team in Cambridge, Massachusetts as a Medical Director (Late Stage). This remote MD role will oversee the study design of clinical trials in Late Development on assigned programs. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.
RESPONSIBILITIES
Lead the preparation of clinical study synopses
Contribute to the writing of protocols/major amendments
Design data collection systems
Interpret clinical data
Prepare final clinical study reports
Represent Medical Science team on assigned Study Management Teams
Include medical science input to overall clinical study planning and execution according to GCP and internal Quality System
Collaborate cross functionally to contribute to data analysis plans and take the lead on the interpretation of clinical trial data
Supervise medical monitoring activities for all human clinical trials in Late Development
Support adverse event reporting and safety management
Monitor adherence to protocols and assist in the investigation of protocol deviations
Create positive and productive relationships with investigators, external organizations, and experts to optimize study design and executions
Provide medical information for inclusion in reports submitted to regulatory authorities and assist in the authoring of regulatory documents
EXPERIENCE
Minimum of 1 year of broad bio/pharmaceutical industry experience in drug development or equivalent required
Knowledge of Neurology and/or Psychiatry required
Knowledge and understanding of the drug development process including technical, business, and regulatory issues
Excellent written and verbal communication skills, strong problem-solving ability, and attention to detail/quality
IND experience strongly preferred
Strong negotiation skills
Highly motivated, decisive, and results-oriented individual with the flexibility and creativity to excel in and contribute to a rapidly growing company
Demonstrated ability to manage multiple projects and proactively identify/resolve issues
EDUCATION
Minimum of Medical Degree required
To be a best-fit your strengths must include:
Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
Organized. You're an efficient time-manager and can handle the pressure of meeting multiple strict deadlines.
Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
Problem-Solvers. As an action-oriented self-starter, you're eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune's Top Workplaces, Chicago's Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.
It is Advanced Group's practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity/expression, sexual orientation/sexual preference, pregnancy/maternity, genetic information, marital status, physical/mental disability, medical condition, military/veteran status, or any other basis protected by applicable federal, state, or local law. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.
