Senior Associate Director, Early Phase Clinical Trial Leader - Oncology (Remote)
US-BI Pharma/BI USA
 Ridgefield, CT

Description:

Key role of the global function Early Clinical Operations (ECO) TCM is twofold:

1) Provide early clinical operational guidance when translational concepts are developed in the Early Clinical Development team (ECDT) in specialty care indications (e.g. Oncology/cancer immunology and immunology) with the intended objective to reach the Proof of Clinical Principle (PoCP) milestone efficiently.

2) Clinical trial leader accountable for preparation, conduct and reporting of PoCP trials under strict compliance with quality and regulatory concepts.

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 a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees

Duties & Responsibilities:

  • Involvement in Immune Oncology Hub:
  • Engagement in the cross functionally staffed Immune Oncology Hub by providing early clinical feasibility considerations and recommendations in the light of innovative development strategies
  • Constructive cross functional networking across the Immune Oncology functions, TMCP groups and local and global Clin Ops functions in the Human Pharma Business Unit (HPBU)
  • Involvement in actual Early Clinical Development Team (ECDT) work:
  • Dedicated ECDT-project work as associated member when new compounds reach the Start of Development (SoD) preparation phase and concepts for PoCP are being designed.
  • Continuous ECDT engagement in the post SoD phase to develop adequately designed PoCP trials and their efficient preparation, conduct and reporting.
  • Continuous ECDT engagement in the post SoD phase to develop adequately designed PoCP/PoCC combination trials in cooperation with HPBU based Clin Ops functions and support of their efficient preparation, conduct and reporting.
  • Trial preparation:
  • Write the Clinical Trial Protocol and all core trial documents, in close cooperation and with input from the project team and ECD team (early clinical development team).
  • Prepare all aspects of trial conduct on a global level, including supervision of vendor contracting, ordering of drug supply, clinical trial supplies and logistics support.
  • Provide input to other trial team members involved in planning of data management (TDM), statistics (TStat), programming (TProg), safety reporting (DSO), onsite monitoring (TCRA) etc.
  • Ensure smooth cooperation with Clinical Trial Supply Unit, Drug Metabolism and Pharmacokinetics (DMPK), biomarkers group, Purchasing, Legal, Medical Data Services, ClinOps functions and other internal and external functions.
  • Plan and report trial budget.
  • Ensure appropriate trial-specific and medical training of the trial team (incl. CMLs, CRAs) and external partners (incl. investigators), including:
  • Provision of training material as adequate.
  • Organize Investigator and CML&CRA meetings as appropriate.
  • Hold regular meetings with the global and local trial teams, maintain necessary flow of information
  • Trial conduct and reporting:
  • Benefit-risk monitoring including regular medical and data quality review with the trial team and ECDT
  • Direct contact for CMLs, investigators and other parts of the trial team for medical questions with regard to trial participation and drug administration.
  • Monitor compliance of trial sites and team to GCP, local regulations and adherence to trial protocol, oversee corrective and preventive actions on global trial level.
  • Responsible for timely, complete and compliant archiving of all relevant global documents for the eCTMF.
  • Ensure timely cleaning and delivery of clinical trial data. Write and coordinate, alone or supported by Medical Writing, the CTR. Support publications of trial data.
  • Clinical development independent administrative projects:
  • Participate, contribute and provide significant input in projects, working groups and initiatives for the improvement of structures, procedures, policies and guidelines within Early Clinical Operations and between Early Clinical Operations and other functions.
  • Medical Advisor function:
  • Train and advise colleagues on medical aspects and background of the clinical trials protocols.
  • Provide advice on safety aspects within clinical trials, e.g. assessment of (serious) adverse events, concomitant medications and treatment of the disease.
  • Review medical aspects in documents of clinical trials.

Requirements:

  • PhD, MD or an equivalent degree from an accredited institution in a pharmaceutical or life sciences
  • Strong and in depth medical knowledge within the field of cancer immunology or immunology including the understanding of current research areas in this emerging indication field.
  • Strong commitment to drive innovation and to be willing to change the standard BI approach into a focused approach that gives characterization of new compounds and the achievement of early go/no-go-decision points as well as reaching fast PoCP highest priority.
  • Highly developed project management and team leadership capability.
  • Good scientific, medical and analytical thinking.
  • Full and permanent awareness of ethical responsibility inherent to research involving human subjects.
  • Sound medical knowledge of the disease under investigation, trial related risks, and understanding of the Investigational Medicinal Product, procedures and study design and their potential impact on patient's wellbeing.
  • Proficiency in all common office software and smooth self-training of new software programs (user).
  • Structured mindset in the approach of complex tasks.
  • Excellent communication, interpersonal and social skills.
  • Very good time management.
  • Commitment to obtaining results / progress in clinical research programs.
  • Strong knowledge in the emerging field of Cancer Immunology / Immunology
  • Strong background in Early Clinical Development / Clinical Pharmacology, especially in early clinical trials of Proof of Mechanism / (clinical) Principle or Concept
  • Relevant working experience with clinical trials in humans, including good understanding of research and development processes as well as in-depth knowledge of relevant regulations in the field
  • Strong and in-depth understanding of team work and high-performance teams
  • Working in multi-cultural environment and in-depth understanding of corporate culture and cross-culture dynamics
  • Experience in working with regulatory agencies
  • Knowledge of regulatory landscape regarding clinical research, especially GCP, Declaration of Helsinki, European Clinical Trial Directive, US FDA guidance’s and safety-related guidelines. Close cooperation with worldwide CMLs and project team.

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

Who We Are:

At Boehringer Ingelheim we create value through innovation

with one clear goal: to improve the lives of patients. We develop breakthrough

therapies and innovative healthcare solutions in areas of unmet medical need

for both humans and animals. As a family owned company we focus on long term

performance. We are powered by 50.000 employees globally who nurture a

diverse, collaborative and inclusive culture. Learning and development for

all employees is key because your growth is our growth.

Want to learn more?

Visit boehringer-ingelheim.com

and join us in our effort to make more health.

Boehringer Ingelheim, including Boehringer Ingelheim

Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Animal

Health USA Inc., Boehringer Ingelheim Animal Health Puerto Rico LLC and

Boehringer Ingelheim Fremont, Inc. is an equal opportunity and affirmative

action employer committed to a culturally diverse workforce. All qualified

applicants will receive consideration for employment without regard to race;

color; creed; religion; national origin; age; ancestry; citizenship status,

marital, domestic partnership or civil union status; gender, gender identity or

expression; affectional or sexual orientation; pregnancy, childbirth or related

medical condition; physical or psychiatric disability; veteran or military

status; domestic violence victim status; genetic information (including the

refusal to submit to genetic testing) or any other characteristic protected by

applicable federal, state or local law.

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