Director - Clinical Development Medical Affairs - Biomarkers Oncology
Boehringer Ingelheim - Connecticut

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133911

Description

The Lead Biomarkers - Oncology will be the US Medical Affairs point person for all questions regarding biomarker development and results in late stage development of the Boehringer Ingelheim Oncology portfolio.
Prepare and lead external interactions on biomarker questions in close collaboration with corporate clinical development and translational medicine. Evaluate clinical trials and summarize outcomes specifically in respect to biomarker results and put these into perspective with efficacy outcomes. Communicate with the scientific community on biomarker development, evaluation, and validation. Communicate with key in- and external stakeholders on US biomarker strategy. If requested, support corporate colleagues with US insights into implementation of biomarker strategies into clinical trials. In the US team, you will be the responsible person for interpretation and communication of relevant strategies. Advise and interact with marketing colleagues on biomarker strategies and ensure high scientific and medical credibility and compliance. Interact with corporate colleagues in translational medicine to ensure strategic alignment in biomarker development.

Through development of relationships and contacts across departments, as well as with outside organizations and consultants, supports the drug development program and development of the national post-approval product maintenance and optimization plan. Leads development and implementation of the annual TA or indication biomarker section component of the Medical Action Plan, and thus help set the strategy for and provide oversight of phase IV and IIS programs by leading a cross-functional team focused on

Personalized Medicine, Biomarkers, Companion Diagnostics & Pathways.

Provides support for other department core functions as need arises such as by support of Medical Legal Regulatory (MLR) or Therapeutic Area Medical Review Committee (TAMRC) team reviews, CME grant provision program, publication planning, and to Medical and Technical Information. Develops advisory/consultant board materials/strategies and provides support to field based medicine team, to Brand Team, as well as to other disciplines as needed. Provides medical/scientific input and advice to Clinical Operations personnel during the local planning, implementation, conduct, and reporting of clinical trials.

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:
Clinical/scientific advisor to the Marketing, HEOR, and/or Managed Markets Departments at the direction of the Executive Director or TA, Oncology VP.

Leads development and implementation of the annual TA or indication section biomarker component of the Medical Action Plan. This includes developing the strategy for local Medical Advisory Board and Expert Panel meetings, Medical Grants, and Medical Publications. Provides strategic direction and scientific support for developing standard response letters and responding to HCP inquiries. Develops local IIS research objectives and serves as a member of the IIS review team evaluating submitted proposals.

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Provides medical/scientific input and advice to Clinical Operations personnel during the local planning, implementation, conduct, and reporting of clinical trials.

Directs Medical personnel and/or participates in Medical-Legal-Regulatory review of promotional materials.

Leads, oversees, and/or contributes to Medical aspects of Regulatory issues related to development compounds or marketed products including labeling discussions/updates, PLRT participation, interactions with Regulatory Agencies, and Annual NDA, IND Report and DSUR submissions.

Gathers, reviews and critically assesses clinical biomarker information, incorporates analysis into written documents (e.g. for regulatory or ethics committee responses) and/or training materials. Develops and implements annual FBM scientific training plan. Provides critical clinical input/training across disciplines. Keeps up to date on scientific and medical progress in the area of development and actively develops and maintains relationships with outside experts in this area.

Plans and implements advisory board meetings as the need arises.

Supports department in fulfilling additional core functions as needed.

Additional core functions include: support of Medical Legal Regulatory (MLR) or Therapeutic Area Medical Review Committee (TAMRC) team reviews,CME grant provision program, publication planning, Medical and Technical Information support, FBM Scientific Exchange Monitoring, and support across disciplines as needed.

Keeps up to date on scientific and medical progress in the area of development and actively develops and maintains relationships with outside experts in this area. Serves as a liaison by representing the company in outside groups.

Perform all Company business in accordance with all regulations (e.g. EEO FDA, OSHA, PDMA, EPA PhRMA, etc) and Company policies and procedures. Demonstrate high ethical and profession standards with all business contacts in order to maintain BIPIs excellent reputation within the medical and pharmaceutical community.

Requirements:
Should have 5+ years of experience for an MD or 7+ years of experience for a PhD.

Medical training and/or clinical experience in internal medicine or pediatrics and preferably the appropriate therapeutic area, Oncology to ensure one's ability to provide accurate scientific expertise to Medical, Operations, and Commercial colleagues.

Experience with clinical trial conduct either as a study investigator or industry medical/clinical monitor and knowledge of GCP.

Must have in depth knowledge of therapeutic area, Oncology, clinical development, regulatory requirements, and have strong analytical and oral and written communication skills.

Must also work well both independently and in teams, have excellent time management skills and be able to work well under pressure.

Thorough understanding of translational research, late stage drug development, and ideally medical affairs experience in oncology.

Experience in interpretation and communication of clinical trial results that did employ biomarker testing strategies.

Strong communication skills.

Being able to effectively function in cross-functional team environment.

Experience in interactions with regulatory health authorities (i.e., FDA).

Ideally have experience in or responsibility for interactions with local and global teams.

Masters Degree and/or Doctoral Degree with a focus in Medicine or Pharmacology and/or Professional training

Medical/professional training and/or clinical experience (including as a physician, nurse practitioner, or physician's assistant) in internal medicine or pediatrics and preferably the appropriate therapeutic area to ensure one's ability to provide accurate scientific expertise to Medical, Operations, and Commercial colleagues.

Those with a Masters degree in science must have 10 years of prior pharmaceutical company experience within the specific therapeutic area which might include experience as a Medical Science Liaison. Experience with clinical trial conduct either as a study investigator or industry medical/clinical monitor and knowledge of GCP.

Must have in depth knowledge of therapeutic area, clinical development, regulatory requirements, and have strong analytical and oral and written communication skills.

Must also work well both independently and in teams, have excellent time management skills and be able to work well under pressure.

Eligibility Requirements:
Must be legally authorized to work in the United States

Must be willing to submit to a background investigation, including verification of your past employment, criminal history, and educational background

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

Must be 18 years of age or older

Our Culture:
Boehringer Ingelheim is a different kind of pharmaceutical company, a privately held company with the ability to have an innovative and long term view. Our focus is on scientific discoveries that improve patients' lives and we equate success as a pharmaceutical company with the steady introduction of truly innovative medicines. Boehringer Ingelheim is the largest privately held pharmaceutical corporation in the world and ranks among the world's 20 leading pharmaceutical corporations. At Boehringer Ingelheim, we are committed to delivering value through innovation. Employees are challenged to take initiative and achieve outstanding results. Ultimately, our culture and drive allows us to maintain one of the highest levels of excellence in our industry. Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Roxane Inc., Roxane Laboratories Inc., Boehringer Ingelheim Chemicals, Boehringer Ingelheim Vetmedica Inc. and Ben Venue Laboratories Inc., is an equal opportunity employer. M/F/D/V

Boehringer Ingelheim is firmly committed to ensuring a safe, healthy, productive and efficient work environment for our employees, partners and customers. As part of that commitment, Boehringer Ingelheim conducts pre-employment background investigations and drug screenings.

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Job

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Clinical Research/Medical Affairs/Drug Regulatory Affairs

Primary Location

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Americas-United States-Connecticut

Organization

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BI Pharma/BI USA

Schedule

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Full-time

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About this company
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As the US headquarters of German drug maker  Boehringer Ingelheim, Boehringer Ingelheim Corporation oversees about half a dozen stateside...