"Alerted.org

Description

The Study Physician (SP) is a critical role within Clinical Development Oncology (CD Onc) to establish readily available medical support and consultancy for clinical trials within CD Onc by a qualified and clinically experienced physician.

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

Duties & Responsibilities

+ Responsible for medical content of Clinical Trial Protocols (CTPs), in line with TDO, in collaboration with CTL, CPL, Patient Safety Physician, Medical Writer and other trial and evidence team members to ensure high medical quality CTP.

+ Responsible for medical input into CTP updates.

+ Strong contribution to trial risk-based quality management from medical perspective, by defining medically relevant critical data/processes, related risks, and its mitigation/monitoring strategies in the Integrated Quality and Risk Management Plan (IQRMP) as well as in risk discussions during trial conduct.

+ Medical responsibility as co-author for development of a robust Clinical Quality Monitoring Plan (CQMP) in line with the critical data, medical quality risks and related monitoring/ mitigations identified in IQRMP.

+ Responsible for providing medical input into definition of important protocol deviations (iPD), providing input for compilation and review of trial iPD list from medical perspective, and support trial team in deciding on iPDs from identified potential iPDs.

+ Responsible for execution of relevant clinical quality monitoring for Study Physician using aggregated data outputs as per trial CQMP, timely mitigation & escalation of identified risks & quality issues.

+ Takes medical responsibility for agile & adaptive risk based Clinical Quality Monitoring of critical data.

+ Supports close to real time clinical data medical oversight by using advanced technologies and systems.

+ Proactively addresses/communicates clinical quality issues in a collaborative environment.

+ Contributes to the timely preparation of medically relevant core trial documents and timely milestones.

+ Responsible for medical input into Data Management documentation for the trial, such as eCRF design by efficient translation of medical questions into electronic data capturing.

+ Responsible for “Information for CRF completion” (ICC), Data Review Plan (e.g., propose items such as data screening rules for automated data queries, automated or manual data checks for clinical data consistency), laboratory parameters specifications for the project, Data Transfer Agreement, central laboratory alerts etc.

+ Responsible for the medical content of Patient Information and Informed Consent, Trial Level Monitoring Manual, Trial Communication Plan, Trial Training Plan, Trial Statistical Analysis Plan (TSAP) etc.

+ Responsible for medical contribution to Patient Narrative preparation, Clinical Trial Report planning and review of medical sections of Clinical Trial Report.

+ Contributes to the medical content of responses to questions from regulators and Ethic Committees/IRBs.

+ Responsible for medical input to study and site feasibility in planning and execution, patient recruitment, and retention plans.

+ Responds to medical queries from Investigators, CROs and/or Sponsor team representatives and contributes to maintenance of trial FAQ log/list.

+ Builds network with experts and active contribution to site engagement.

+ Supports Endpoint Adjudication (EA), Data Monitoring Committee (DMC), Data Safety Monitoring Boards (DSMB) and Steering Committees (SC) (as applicable), by presenting medical content of study to the respective committees, responding to medical questions and by ensuring good quality of data from CQM perspective.

+ Provision of medical training at Country feasibility training, Trial Investigators Meetings or to Sponsor staff.

+ Responsible for medical review of and contribution to the content of Trial Newsletters.

+ Contributes to the scientific publication of trial data (If applicable).

Requirements

+ Physician (MD) (ideally with medical thesis), trained in a clinical setting, and minimum of four (4) years of active clinical practice experience; specialization in internal medicine or general practice is desirable. MD in Oncology is preferred.

+ Experience specifically in Oncology Clinical Development is preferred.

+ Experience in pharma industry or CRO in medical or project management functions (ideally in Clinical Development) is desirable

+ Ability to communicate directly and concisely while collaborating with key stakeholders.

+ Pronounced analytical skills and systematic and well-structured working style.

+ Pronounced presentation and training skills.

+ Capability to work proactively and with team spirit in an international environment and team.

+ Displays the ability to use digital technologies to access information, be creative, innovative, solve problems, communicate, navigate, learn & apply in a digital environment.

+ Excellent interpersonal, active listening, influencing skills and fluency in English, both written and spoken.

**Eligibility Requirements** :

+ Must be legally authorized to work in the United States without restriction.

+ Must be willing to take a drug test and post-offer physical (if required).

+ Must be 18 years of age or older.

Compensation

This position offers a base salary typically between $220,000 and $350,000.  The position may be eligible for a role specific variable or performance-based bonus and or other compensation elements.   For an overview of our benefits, please click here.

All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.