Medical Director Oncology Therapeutics 8/20/2020
JOB DESCRIPTIONAPPLY OVERVIEW
We are currently searching for a skilled professional to join a well-known client's team as a Medical Director Oncology Therapeutics in Cambridge, Massachusetts. The Medical Director Oncology Therapeutics role will lead and demonstrate ownership of the design and implementation of clinical development programs based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, business operations, and emerging issues. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.
* Own design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses, and other program documents
* Oversee project-related education of investigators, study site personnel, and study staff
* Understand the regulatory requirements related to the clinical studies and global drug development and comply with those requirements
* Serve as a clinical representative for key regulatory discussions
* Participate in the development of clinical outsourcing specifications to facilitate bid templates and selection of CROs
* Manage interface with CROs in cooperation with the head of clinical operations
* Ensure adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures, and to all other quality standards in conducting research
* Lead clinical study teams and monitor integrity of assigned studies
* Review, interpret, and communicate accumulating data pertaining to safety and efficacy of the molecule
* Assess and report serious adverse events per corporate policy and regulations for those protocols on which assigned
* Minimum of 3 years of related clinical oncology experience in a pharmaceutical company or biotech firm required
* Experience in technical, operational, and managerial activities in planning, executing, reporting, and publishing clinical studies
* Demonstrated experience in clinical research publication history
* Experience in developing effective relationships with key investigators
* Detailed knowledge of GCP, clinical trial design, statistics, regulatory processes, and global clinical development process
* Advanced knowledge of Oncology and Hematology required
* Minimum of MD with board qualification or experience in medical oncology required
* MD/PhD preferred
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.