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EMD Serono, Inc. · 3 days ago

Scientific Director, Fertility

Boston, MA

Full-time

Hybrid

Lead/Staff, Director/Executive

$155K/yr - $232K/yr

5+ years exp

EMD Serono is a global leader in healthcare, dedicated to improving and prolonging lives through innovative solutions. The Scientific Director, Fertility will lead evidence generation activities to support the Fertility organization, enhancing the understanding of the fertility portfolio and driving strategic planning and execution of clinical studies.

BiotechnologyHealth CareHealth Diagnostics

Work & Life Balance

No H1B

Responsibilities

Lead US Fertility Strategic Evidence Generation Planning: Collaborate closely with the Fertility TA Head, Fertility Medical Director team, North America Evidence and Value Development team, Clinical Development (R&D), and Global Medical Affairs, to develop and implement comprehensive evidence generation strategies for the Fertility organization across clinical studies, real-world evidence studies, and patient experience focused studies; includes short- and long-term strategic planning to evaluate and address evidence gaps using a multitude of evidence generation approaches including company-sponsored studies (CSS), collaborative research studies (CRS), and investigator-sponsored studies (ISS); set strategically aligned, annual areas of interest for ISS; strategic contributor to annual Medical Affairs brand plans

Lead Clinical Evidence Generation Execution: Collaborate with cross-functional teams, including clinical development and clinical operations, to execute and monitor US-driven/supported CSS, CRS and ISS, ensuring compliance with regulatory requirements and alignment with company objectives

Engage with External Experts: Cultivate relationships with researcher, authors, editors and key opinion leaders (KOLs), academic institutions, professional societies, patient advocacy groups and other external parties to gather insights on evidence needs and facilitate their involvement in clinical studies and execute the publication strategy

Present at Conferences and Meetings: Represent the organization at scientific conferences and meetings, delivering presentations on research findings and advancements in fertility, while engaging with the scientific community to foster collaboration and knowledge exchange

Analyze and Interpret Data: Proactively identify data gaps within existing clinical trial, real-world study, and patient experience data to inform and drive strategic research questions, facilitating the development of targeted studies that address unmet needs and enhance the overall evidence generation framework; generate actionable insights that inform product positioning, messaging, and strategic planning

Collaborate on Publication & Communication Strategies: Collaborate with Medical Directors, Scientific Communications, and Field Medical leadership to develop publication strategies for disseminating study results and evidence, ensuring alignment with scientific and regulatory standards, and to develop field medical materials and discussion guides

Monitor Industry Trends: Stay abreast of developments in the fertility landscape, including competitive data generation activities, to inform strategic planning and evidence generation efforts

AI-first Mindset: Leverage innovative AI solutions to advance research studies, enhancing evidence generation processes and optimizing data collection and analysis

Train and Mentor Team Members: Provide guidance and mentorship to MSLs and other team members on evidence generation methodologies and best practices, fostering a culture of scientific excellence within the team

Qualification

Scientific leadershipEvidence generationFertility expertiseClinical studies managementData analysisPublication strategyNetworking skillsSoftwareFluent in EnglishCommunication skillsInterpersonal skillsProject managementTeamworkOrganizational skills

Required

PharmD, PhD, DO, MD and 5+ years of clinical or pharmaceutical experience and scientific experience within fertility

Strong track record of scientific leadership, evidenced by a portfolio of peer-reviewed publications in reputable journals

Established credibility within the scientific community, evidenced through active participation in conferences, workshops, and collaborative research efforts

Preferred

Advanced scientific knowledge with strong relationship-building and networking skills

Proven scientific leadership, demonstrated by a publication record in high-impact journals

Reputation in the field of fertility, with a strong network of professional relationships and collaborations

Experience managing evidence generation projects, including clinical studies and investigator-sponsored studies

Demonstrated understanding of pharmaceutical or biotechnology products data generation process (Phase 1 to Phase 4) and Good Clinical Practice guidelines (GCP)

Excellent communication and presentation skills, capable of engaging customers and internal stakeholders in both small and large group settings

Highly developed interpersonal and teamwork skills

Ability to build ongoing and productive relationships throughout the organization to achieve business goals

Excellent organizational and time management skills, with a strong focus on project management

Proficiency in data collection software, project management tools, PowerPoint, Word, Excel, and other relevant tools

Fluent in English