Associate Director/Director, Integrated Evidence Generation, Ophthalmics
Ciao! At Dompé, our success is rooted in our team and our history. We are a private, rapidly growing global biopharmaceutical company. Founded in Milan, Italy, we have a 165-year legacy of medical innovation. Dompé’s rich history has greatly influenced its priorities today: to innovate for the benefit of patients facing both everyday wellness needs and rare conditions. Dompé operates in two strategic areas in select markets around the world: Primary Care, which includes prescription and over-the-counter products; and Biotechnology and Rare Disease, which recently expanded into the United States.
Today Dompé has 700 employees worldwide and we are excited to be rapidly scaling in the United States. Our R&D hub is currently based in Boston, and the commercial organization is housed in the San Francisco Bay Area.
PURPOSE OF THE ROLE
The Associate Director (or Director level), Integrated Evidence Generation will work closely with the Director, US Neurotrophins to design, plan, direct, and implement medical evidence generation and Phase IV clinical studies for Ophthalmics, with the goal to support clinical adoption and/or optimize labelling while maximizing access for patients by addressing strategic data needs.
This role is responsible for generating data in close alignment with the relevant internal and external stakeholders and building external relationships with patient and research organizations to enable access and adaptation of these key data. Additionally, you will work closely to drive a process to understand barriers and knowledge gaps in the appropriate therapeutic areas, orchestrate development, and oversee execution and dissemination of strategic evidence generation through the utilization of the integrated data generation plans and data generation activities.
The Associate Director will be responsible for ensuring the execution of short, mid, and long-term evidence generation strategies cross-functionally to successfully deliver highly relevant and robust evidence to support product lifecycle strategy with the intent to publish and communicate the evidence generated. This role will collaborate closely with internal cross-functional colleagues, to track implementation and tactical execution of Data Generation plans and act as a key scientific subject matter expert for relevant internal projects and teams.
MAIN AREAS OF RESPONSIBILITIES OF THE ROLE
- Ownership and development of data generation plans for all post-marketing clinical trials (company-sponsored and investigator-initiated)
- Provide medical oversight for phase IV protocol development, interpretation of trial results, final study report conclusions, and publications. Provide critical medical input into the lifecycle management strategies in Ophthalmics.
- Development of annual advisory board plans for pipeline and post-marketing clinical trials
- CRO selection and management for company sponsored post-marketing trials to ensure timely execution and achievement of key business objectives
- Oversight and review of all protocol, budgets, and contracts for investigator-initiated- research
- Responsible for annual data gap analysis to develop and evolve the product evidence generation for each asset throughout its lifecycle
- US pivotal trial site identification and selection to support Clinical Operations
- Medical/Scientific subject matter expert: Serve as a medical subject matter expert for all clinical trial information and data providing direction for assigned products including (but not limited to) scientific communications, publication review, advisory boards, real-world evidence and health outcomes plans, MSL activities, investigator-initiated research, and other internal key business processes.
- Present ongoing clinical trial information to a variety of audiences (KOLs, HCPs, hospital/decision making teams, etc.) upon requests and/or according to country medical plans for publicly available data.
- Conduct therapeutic training for Sales and Medical colleagues for new and ongoing post-marketing trials as updates occur, ensure MSLs are experts in ongoing trials to speak to publicly available information.
- Develop FAQs for all ongoing trials for KAMs, MSLs and internal colleagues
- Ensure cross functional and global partners are informed on ongoing post-marketing trial activities
- Leadership, Strategic Planning and Operational
- Ensure post-marketing clinical trials meet yearly business KPIs and manage metrics to track success
- Responsible for all CRO activities for all ongoing post-marketing clinical trials in the US, including CRO selection and timeline execution. Hosting all check in calls and internal communication calls for trials
- Plan and direct strategic activities including prioritizing and selecting appropriate projects with overall responsibility for meeting business objectives. Lead in identifying risk, developing complex mitigation strategies, best practices, alternative solutions, resolving issues, etc. in collaboration with cross functional teams
- Serve in an advisory role to clinical development and clinical operations to provide strategic direction and guidance on programs. Serve as the core team member representing Clinical Affairs function on appropriate internal teams.
- Lead advisory boards and consulting sessions related to post-marketing clinical data, clinical affairs strategy, and relevant special projects
- Lead presentation of annual data generation plans during internal workshops where appropriate
- Clinical Knowledge and Expertise
- Maintain awareness of and access to internal and external information sources
- Develop/increase knowledge of medical literature and critical appraisal of scientific publications
- Maintain knowledge base and scientific expertise on all assigned disease states and products
- Develop and update knowledge of applicable pharmaceutical guidelines and regulations. Code of Ethical Practices and company policies
MAIN AREAS OF RESPONSIBILITIES COMMON TO PEOPLE MANAGER (if applicable)
- Develop impactful business goals and ensure strategy execution by clinical development manager
- Assist the Director, US Neurotrophins in clinical affairs team hiring, training, evaluations, motivation and performance enhancement activities in alignment with the company’s corporate strategies and objectives
- Work with direct reports to identify professional development goals and opportunities
- Foster an inclusive and innovative environment recognizing successes along the journey
- An advanced degree in life sciences (MD, PhD, OD or equivalent)
- Ability to work independently, taking responsibility for the management of processes, projects and timelines
- Excellent business judgment and strong oral and written communication skills
- Require minimum 5 years’ experience in the pharmaceutical industry within Ophthalmology, including knowledge in post-marketing trials and clinical research or significant relevant research or clinical experience in the therapeutic area is required
- Demonstrated leadership and effectiveness in strategy development and execution
- Travel to headquarters and appropriate key conferences expected (~20%)
- Availability to attend meetings on holidays and weekends
- Clean and valid driver’s license
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.