Develop, execute, monitor, and adapt strategic MSL stakeholder engagement plans.
Lead high-quality scientific exchange through both proactive and reactive interactions.
Identify and communicate insights, trends, and activities of other Medical Affairs organizations.
They focus on engaging key opinion leaders (KOLs) and healthcare providers in high-quality scientific exchange. They drive insight generation and contribute to the development and execution of medical strategy.
Works collaboratively within CMC regulatory and technical operation teams on writing projects for early, late-stage development, and commercial programs.
Contributes to drafting, reviewing, and finalizing CMC content and regulatory documents such as Module 3 sections for INDs, BLAs, and MAAs.
Plans and manages writing projects, ensuring documents meet quality standards and adhere to corporate SOPs and evolving global regulations.
Iovance Biotherapeutics aims to be the global leader in developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are an innovative biotechnology company pioneering a transformational approach to treating cancer by harnessing the human immune system.
Assist in the ongoing development, implementation, and maintenance of the Company’s compliance program.
Develop policies and procedures that provide appropriate guidance and instruction to Company employees.
Lead the development and delivery of compliance training programs for employees at all levels.
Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies. They aim to provide significantly better survival rates with dramatically fewer risks. They have a start-up culture of camaraderie and leadership by example.
Identifies and develops professional relationships with thought leaders and healthcare professionals.
Supports research initiatives and serves as a liaison for investigator-initiated research.
Delivers impactful presentations and provides accurate assessments of community needs.
Mirum Pharmaceuticals is dedicated to transforming the treatment of rare diseases by advancing scientific discoveries. They are collaborative, creative, and experienced professionals with a culture embodying care, authenticity, dedication, and fun.
Serves as a senior regulatory authority and trusted strategic partner to pharmaceutical and biotech C-suite executives, influencing enterprise-wide regulatory strategies.
Partners with the SVP & Practice Lead to shape the future direction of the Clinical & Regulatory practice, driving practice growth and translating regulatory landscape evolution into opportunities.
Proactively supports the practice's P&L, achieving annual revenue targets, leading pursuit strategies for high-value engagements, and setting delivery quality standards across the regulatory team.
Lumanity is dedicated to improving health outcomes by accelerating and optimizing access to life-changing medicines. As a global strategic partner, it brings together strategy, evidence, engagement, and technology to engineer breakthrough value for clients in the healthcare sector.
Develop advocacy with key stakeholders and KOLs within the head and neck cancer space, to support the continued success of LOQTORZI.
Lead external engagements and support in-line brand marketing initiatives for LOQTORZI.
Develop a strategic Regional engagement plan in coordination with cross functional partners.
Coherus is a commercial-stage biopharmaceutical company focused on the research, development and commercialization of novel immuno-oncology therapies. At Coherus, they provide equal employment opportunities to all employees and applicants for employment and prohibits unlawful discrimination and harassment.
Serves as the medical monitor for clinical trials and assists in resolving major issues that may affect their assigned studies.
Partners with the Clinical Scientist, Data Manager, Pharmacovigilance Scientist, and other members of the study team to conduct the clinical studies.
Provides expert opinion and review for creation of key study documents, including clinical study protocols, safety and medical monitoring plans, charters, and informed consent forms.
Cullinan Therapeutics is a biopharmaceutical company developing potential first- or best-in-class, high-impact therapies for cancer and autoimmune diseases. They have a clinical-stage pipeline built on a rigorous scientific approach and purposeful innovation, and are advancing its mission to deliver new standards of care for patients.
Translate program strategy into integrated timelines, milestones, and deliverables.
Manage one or more highly complex R&D programs and/or high-profile partnerships.
Lead cross-functional program management activities supporting autoimmune clinical development programs.
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. We are committed to transforming the future of treatment for autoimmune disease.
Lead regional launch planning and execution to ensure successful market entry and product uptake.
Recruit, onboard, develop, and retain top-performing territory managers across the region.
Develop and maintain relationships with key healthcare providers and strategic accounts.
Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities. Mineralys is a fully remote company headquartered in Radnor, Pennsylvania, and it values collaboration, integrity, quality, trust, and urgency.
Drive Capricor’s U.S. distribution channel strategy, including 3PL selection and oversight.
Build and run Capricor’s U.S. patient services model across therapeutic areas, including referral intake.
Map, standardize, and enhance patient journeys across programs to reduce access friction.
Capricor Therapeutics is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. The company's lead cell therapy is in late-stage development for Duchenne muscular dystrophy, and they are also working on targeted delivery and vaccinology.
Analyze & identify the optimal positioning to successfully deploy our science, models and products.
Identify, negotiate, and manage strategic partnerships with key stakeholders in biopharma.
Drive revenue growth by meeting or exceeding business development targets.
Bioptimus is building the first universal AI foundation model for biology to fuel breakthrough discoveries and accelerate innovation in biomedicine. With more than $75M in funding, our fast-growing start-up is headquartered in Paris and backed by leading international venture capitalists.
Planning, development, and oversight of scientific content for assigned accounts.
Leading client interactions and brand strategy, as well as the scientific portion of brand planning and business development.
Managing resource allocation, partnering with client services to develop SOWs and timelines and identifying areas for new and organic growth.
Lockwood collaborates with clients in the pharmaceutical, biotech, and medical device industries to identify effective, holistic, science-based strategies to address their objectives through medical communications. Our flexible structure provides better work-life balance; they attract the best talent and are more responsive to their clients.
Provide technical and strategic leadership for late-stage CMC activities.
Work with internal and CDMO CMC teams to ensure timely delivery of PC & PPQ protocols and reports.
Lead CMC meetings and ensure teams are aligned with overall CMC and program strategy.
Oruka Therapeutics is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. They aim to offer patients suffering from chronic skin diseases the greatest possible freedom from their condition. The company seeks passionate individuals eager to contribute to an engaged, inclusive, and positive company culture.
Responsible for planning, development, and oversight of scientific content.
Provide clients with strategic medical communication recommendations.
Independently lead execution of content development activities.
Lockwood collaborates with clients in the pharmaceutical, biotech, and medical device industries to identify effective, holistic, science-based strategies through medical communications. Over a third of their staff hold advanced scientific or medical degrees, and most work from where they live.
Author, review, and manage clinical, regulatory, technical, and medical documents including protocols, study reports, and regulatory submissions.
Ensure strategic alignment and consistency of scientific messaging across documents while maintaining compliance with global regulatory requirements.
Drive the end-to-end writing process, manage timelines, and lead cross-functional reviews to deliver high-quality, on-time deliverables.
Kiniksa Pharmaceuticals is a commercial-stage biopharmaceutical company developing and commercializing novel therapies for diseases with unmet need, focusing on cardiovascular indications. The company fosters a highly collaborative, patient-first culture led by accomplished life sciences leaders, empowering talented individuals to make a real impact.
Own the end-to-end lifecycle of FDA premarket applications, with an immediate focus on authoring and steering 510(k) submissions to clearance.
Operationalize and maintain compliance across diverse and intersecting jurisdictions, including FDA (Device, Drug & Compounding) and CMS (CLIA/CAP).
Build and scale the "Technical Playbook" for medical product operations, ensuring the company stays ahead of shifting state, federal, and international regulations.
Hims & Hers is a health and wellness platform committed to better health by offering affordable and personalized care. As a public company traded on the NYSE, they are normalizing health & wellness challenges and innovating on their solutions to make better health outcomes easier to achieve.
Author, maintain and implement study-specific Clinical Quality Audit Plan(s) for assigned clinical program(s).
Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As a trailblazer in anti-FcRn technology, they are developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases.