Job Information
Boehringer Ingelheim SR AD / Director, Clinical Development & Operations Lead (CDOL) - Cardio Renal Metabolic (Remote) in Ridgefield, Connecticut
Description
The Clinical Development Operations Lead (CDOL) is responsible for operational planning, oversight and delivery of clinical programs within assigned indication or given asset with focus on speed, value and quality. The CDOL is functionally part of the clinical evidence team. The CDOL is accountable for maintaining standards across clinical trial documents and processes within an assigned indication or asset.
The CDOL is responsible for identifying and utilizing common efficiencies and lessons learnt in supplier selection, country and site selection, expert engagement, trial planning, conduct and delivery across multiple trials within the same indication/asset. CDOL reports into the Head of Clinical Development and Operations Therapeutic Area Cardio Renal Metabolic (CRM). The CDOL is a global role and may have local direct reporting within local CD&O. The CDOL act as the functional manager for CTL assigned to trials within given indication/asset by mentoring, problem-solving and motivating trial teams to deliver clinical acceleration and value. CDOL is responsible for fulfilling key performance indicators that fulfill aspirations of Medicine Excellence for accelerated clinical delivery of asset.
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
CDOL leads the clinical delivery within the Clinical Evidence Team. As a leader of clinical delivery for assigned indication/asset, CDOL is responsible for operational input into Clinical Development Plan (CDP) for both early and late phase clinical trials. CDOL will support program team in developing scenarios for trial timelines and strategy to meet key performance indicators set by Medicine Excellence Project 2020. The CDOL will collaborate with other functions (Medical Writer, Study Physician, Clinical Program Leader, PSTAT and PDM) to ensure document standards are developed and maintained across multiple trials within a given asset to avoid redundancies and improve efficiency. CDOL is responsible for collaborating with Clinical Trial Supply Unit in determining a comparator sourcing strategy if used for multiple trials. The CDOL is responsible for a sourcing strategy to determine supplier needs that can apply across multiple trials within a given asset (e.g. ePRO, DMC, adjudication, imaging, central labs, etc.)
CDOL contributes to digital innovation and use of novel trial designs. CDOL is responsible for utilizing data, technology and input from external stakeholders (patient groups and potential investigators) to determine realistic timelines, identify feasibility issues, roadblocks, supplier needs, external committees and expert mapping for the clinical trials before handing over to a Clinical Trial Lead (CTL).
Accountable for operational input to ensure patient centricity and expert engagement that applies to all trials within a given indication/asset. The CDOL is accountable for applying patient input gathered from other programs within same indication, avoid redundancy and build knowledge for the evidence team. CDOL is responsible for maintaining longitudinal engagement of experts throughout the development lifecycle of given asset or across multiple assets developed for same indication.
CDOL is responsible for providing performance feedback for CTL and CTM that are assigned to trials within given indication/asset but located and reporting locally in Regions. Responsible for training and motivating talents who are willing to take on a CTL role for first time.
Education & Experience Requirements
Candidate will be hired in at the level based on the education, experience and business need.
CDOL (Senior Associate Director)
Bachelor degree from an accredited institution.
MD or PhD desirable.
Ten-plus (10+) years of experience in clinical development or operations.
Experience specific to Obesity/NASH is highly preferred
Senior CDOL (Director)
PhD or MD. Specialist with > 5 years’ experience in respective TA
Or a science degree with > 15 years’ experience in clinical trials
Extensive experience (>10 years) across all stages of clinical drug development
Experience specific to Obesity/NASH is highly preferred
Position Requirements
Comprehensive understanding of Clinical Development and Clinical Operations in the context of the evolving role of pharmaceutical industry in the healthcare environment
Proven track record on overseeing and running global clinical trial programs managing complex projects and working collaboratively with multiple stakeholders leading highly engaged and performing teams.
Extensive experience across all stages of clinical drug development
Advanced understanding of/experience with the application of novel, digital technologies in healthcare
Advanced knowledge of existing and emerging global regulatory, ethical and compliance requirements for clinical research.
Proven track record of leading and driving business process and/or digital transformation and organizational culture change.
Commitment to high ethical standards and desire to transform lives of patients with unmet needs.
Leadership mindset with ability to lead by example, attract and develop talent.
Very strong strategic mindset and excellent communications and negotiation skills.
Proven ability to build internal relationship and exert influence in a matrix and virtual environment and external relationship with thought leaders, industry bodies, etc.
Ability to create a culture of collaboration and being able to reach out beyond organizational boundaries for constructive solution finding.
Be able to drive decision making with organizational flexibility across Global TAs, Corporate Medicine and Global Regions.
Proven track record in the creation/execution of digital innovation projects in healthcare.
Requires comprehensive/deep knowledge of the Medicine strategy and vision as well as. comprehensive/deep knowledge or understanding of the TA strategy and vision.
In-depth knowledge of the strategy of competitors and of developments/trends in the market.
Solid Medical/Scientific understanding, including general understanding of Pharma industry, rules and regulations.
Visionary: Ability to step back from one’s daily routine, explore ideas for the future, regard the facts from a distance and see them in a broader context or in the longer term.
Develops (& discovers) individuals & builds effective teams.
Customer orientation: Ability to actively and truly engage with customers, building strong customer relationships and delivering customer-centric solutions.
Stakeholder management: Ability to effectively build and manage relationships with many different (internal & external) stakeholders, engaging with them in a planned and meaningful way in pursuit of our strategic objectives, and feeding intelligence back across BI to deliver maximum.
(Agile) Project Management: Ability to initiating, plan, executing, controlling and closing projects including reporting on results and/or lessons learned.
Effective Communication & Influencing Skills: Ability to have a positive impact on others, to persuade or convince them in order to gain their support.
Financial acumen: Ability to interpret and apply understanding of key financial indicators to make better business decisions.
Compensation
This position, depending on level, offers a base salary typically between $150,000 and $261,000. The position may be eligible for a role specific variable or performance-based bonus and or other compensation elements.
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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.