191 Medical Research jobs in Bethesda

Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, and a diverse pipeline of early- to late-stage assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ( or follow us on LinkedIn ( .
**Job Overview**
We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Senior Medical Director, Clinical Research (Ophthalmology) to join our R&D Organization.
This individual will contribute to the design and execution of clinical development plan(s) for assigned asset(s) and serve as the Clinical Research Lead for stem cell program within the Ophthalmology therapeutic area.
**Job Duties and Responsibilities**
+ Responsible for and lead all activities related to clinical study design from clinical study concept to clinical study protocol for both early- and late-stage programs
+ Leads or joins multi-disciplinary, multi-regional, matrix team through highly complex decisions
+ Leads and drives strategy for clinical studies for assigned asset(s) within the Ophthalmology therapeutic area
+ Provides oversight of clinical trial conduct, interacting with CROs, medical monitors, and vendors as required, and working with the safety group to ensure adequacy of safety monitoring and reporting
+ Provide clinical input for and participate in study set up and design including data collection tools, data analysis, eCRF design, edit checks, vendor database design plans, etc.
+ Study-level, site-level and subject-level data review and interpretation, including documentation and summarization of findings
+ Serve as the internal medical monitoring for clinical trials
+ Review and provide input for the design of the statistical analysis plans, TLFs, and the clinical data output
+ Contributes to interpretation of clinical trial results and the writing of clinical study reports
+ Contributes to the preparation of Investigator Brochures, annual reports, data collection systems and final reports in compliance with appropriate scientific/regulatory/medical standards
+ Contributes to developing clinical components of BLA/NDAs, sNDAs, MAAs and other regulatory filing documents
+ Contributes to company responses to health authorities and ethics committees for ongoing clinical programs to ensure timely registration and initiation of trials globally
+ Contributes to the development of presentation materials for investigator meetings, health authority meetings, scientific advisory board meetings, and national and international scientific meetings
+ Serve as the subject matter expert for ophthalmology, representing Clinical Research to both internal and external customers
+ 20% domestic and international travel
**Key Core Competencies**
+ Knowledge and understanding of FDA, GCP, and ICH regulations and guidance
+ Thorough and up-to-date knowledge of therapeutic area including trends, advances, understanding of currently available therapies and competitive clinical landscape
+ Experience in conducting global clinical trials in both early- and late-stage clinical development, especially protocol development and trial initiation
+ Experience in regulatory submissions in US; preferred experience in Europe and Japan
+ Demonstrated ability to set clear priorities, lead, influence and build consensus in a multi-disciplined team environment
+ Strong team leadership skills and ability to motivate large multi-functional teams
+ Ability to effectively synthesize, interpret and present scientific information to both internal stakeholders and external medical community
+ High degree of organizational awareness, ability to connect the dots to understand all the interdependencies and big picture
+ Excellent interpersonal and communication skills with the ability to balance multiple tasks and work within a multi-disciplinary team
**Education and Experience**
+ MD (or international equivalent)
+ Board certified or board eligible in ophthalmology
+ Fellowship training in vitreoretinal surgery (preferred) or retina
+ A minimum of 5 years' experience in the pharmaceutical industry, with experience as Clinical Research Lead in Ophthalmology therapeutic area
+ Experience in regenerative cell medicine or gene therapy preferred
+ Prior experience working with Japan organizations is preferred
The base salary range for this role is $284,320 to $355,400. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.
Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
**Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.
**Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
**Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.
**Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer**
Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website or follow us on LinkedIn.
Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at
This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.
At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars.
**Our** **Mission**
_To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_
**Our** **Vision**
_For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_

**Join Amgen's Mission of Serving Patients**
At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
**Clinical Research Medical Sr. Director - Thoracic Oncology**
**What you will do**
Let's do this. Let's change the world. In this vital role you will serve as clinical expert to provide clinical/scientific knowledge into the development, delivery and communication of the global scientific/medical evidence plan for small cell lung cancer (SCLC) indication(s). Additional responsibilities include:
+ Provide therapeutic area expertise in thoracic oncology and drive development, execution, and communication of the global scientific/medical evidence plan for small cell lung cancer area, including leading the evidence generation team.
+ Serve as global development lead for specific small cell lung cancer indications and/or patient impact expansion (PIE) strategies.
+ Integral contribution to SCLC product team
+ Manage a clinical development team of clinical research medical directors and medical science directors
+ Provide medical leadership for clinical trials and develop and implement strategies to drive patient enrollment in partnership with clinical operations and medical affairs organizations.
+ Support cross-functional and global collaborations to integrate broad medical, regulatory, safety, scientific, and commercial access and value input into the development program(s)
+ Participate and provide clinical input into safety and regulatory interactions.
+ Interpret and communicate clinical trial data.
+ Lead authoring and review of CSRs, publications and regulatory submissions
+ Develop key opinion leaders and make scientific presentation at advisory boards, key scientific meetings and external committee meetings
+ Identify new clinical research opportunities.
+ Provide clinical content input to materials to be used in Scientific Affairs as well as the Commercial Organization
+ Approximate 10% travel may be required.
**What we expect of you**
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.
**Basic Qualifications:**
MD or DO degree from an accredited medical school
AND
5 years of clinical research and/or basic science research experience
AND
5 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
**Preferred Qualifications:**
+ MD plus accredited residency and fellowship training in oncology, board certified or equivalent. Five (5) or more years of clinical development experience and/or basic science research combined with clinical teaching and patient care activities.
+ Clinical development experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company)
+ Experience in development lifecycle management to include development strategy creation for large programs from early development, through late development and commercialization.
+ Involved in filing activities as part of the moving the program through the development lifecycle.
+ Key relationship development and collaboration with the expansive commercial and medical teams internal and external partners and key opinion leaders.
+ Previous management experience of clinical development professionals
**What you can expect of us**
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
+ A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
+ A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
+ Stock-based long-term incentives
+ Award-winning time-off plans
+ Flexible work models, including remote and hybrid work arrangements, where possible
**Apply now and make a lasting impact with the Amgen team.**
**careers.amgen.com**
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
**Application deadline**
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Our client, a leading pharmaceutical company, is seeking a highly motivated and experienced Clinical Research Scientist specializing in Oncology. This is a fully remote position, offering the flexibility to work from home across the US. You will play a crucial role in the design, execution, and interpretation of clinical trials for novel cancer therapies. The ideal candidate will possess a strong scientific background, extensive knowledge of oncology drug development, and a proven track record in clinical research. Responsibilities include contributing to clinical trial protocols, developing statistical analysis plans, overseeing data collection and analysis, and preparing scientific reports and publications. You will collaborate closely with cross-functional teams, including R&D, regulatory affairs, and medical affairs, to ensure the successful advancement of clinical programs. A deep understanding of regulatory requirements (e.g., FDA, EMA) and good clinical practice (GCP) is essential. The successful candidate will have excellent analytical, problem-solving, and critical thinking skills, as well as strong written and verbal communication abilities. Experience with clinical trial design and management, statistical software, and data visualization tools is highly desirable. We are looking for a passionate and dedicated scientist who is committed to advancing cancer research and improving patient outcomes. This is an exceptional opportunity to make a significant contribution to life-saving therapies within a leading pharmaceutical organization, with the convenience of a remote work arrangement.

Our client, a leading pharmaceutical innovator, is seeking an accomplished Senior Clinical Research Scientist to join their dedicated team in Washington, D.C. . This critical role involves spearheading the design, execution, and interpretation of complex clinical trials for novel therapeutic agents. You will be instrumental in advancing drug development pipelines from early-stage research through to late-stage clinical phases, ensuring scientific rigor and regulatory compliance at every step. Your expertise will guide protocol development, data analysis strategies, and the preparation of regulatory submissions.

Responsibilities include collaborating with cross-functional teams, including R&D, medical affairs, biostatistics, and regulatory affairs, to ensure seamless trial progression. You will provide scientific leadership and mentorship to junior researchers, foster a culture of innovation, and stay abreast of the latest scientific literature and emerging trends in pharmaceutical research. A significant part of your role will involve analyzing clinical data, identifying key findings, and translating them into actionable insights for strategic decision-making. You will also contribute to the development of scientific publications and presentations for key conferences.

The ideal candidate possesses a Ph.D. or M.D. in a relevant life science discipline (e.g., Pharmacology, Biochemistry, Medicine) and a minimum of 7 years of experience in clinical research within the pharmaceutical or biotechnology industry. Demonstrable experience in designing and managing Phase II/III clinical trials, a deep understanding of Good Clinical Practice (GCP) guidelines, and a proven track record of successful regulatory interactions (e.g., FDA, EMA) are essential. Exceptional analytical, problem-solving, and critical thinking skills are required, along with outstanding written and verbal communication abilities. Experience with specific therapeutic areas such as oncology, immunology, or neurology is highly advantageous. Strong leadership qualities and the ability to work effectively in a fast-paced, collaborative environment are crucial for success in this position.

This is an exceptional opportunity to make a significant impact on patient lives by contributing to the development of life-changing medicines. You will work at the forefront of pharmaceutical science, collaborating with world-class experts and enjoying state-of-the-art facilities. Join us in shaping the future of healthcare from our prominent location in the nation's capital.

Our client is seeking a highly accomplished Senior Clinical Research Scientist to join their esteemed pharmaceutical division. This critical role will lead the design, execution, and interpretation of clinical trials, contributing significantly to the development of groundbreaking therapies. You will be responsible for developing study protocols, managing investigator sites, analyzing clinical data, and ensuring compliance with regulatory standards. A strong background in pharmaceutical research and a deep understanding of clinical trial methodologies are paramount.
Responsibilities:

• Design and develop clinical trial protocols, informed by scientific literature, regulatory guidelines, and therapeutic area expertise.
• Oversee the planning and execution of clinical studies, ensuring adherence to timelines, budgets, and quality standards.
• Manage relationships with investigative sites, Contract Research Organizations (CROs), and other external partners.
• Develop and implement data collection and monitoring plans, ensuring data integrity and accuracy.
• Analyze and interpret clinical trial data, preparing comprehensive reports for regulatory submissions and publications.
• Ensure compliance with all applicable regulatory requirements (e.g., FDA, EMA, ICH-GCP).
• Collaborate with cross-functional teams, including R&D, regulatory affairs, medical affairs, and biostatistics.
• Contribute to the strategic planning and lifecycle management of pharmaceutical products.
• Mentor and guide junior research staff.

Qualifications:

• Ph.D. or Master's degree in a life science, medical, or pharmaceutical field.
• Minimum of 7 years of experience in clinical research within the pharmaceutical or biotechnology industry.
• Proven experience in designing and managing Phase I-IV clinical trials.
• In-depth knowledge of clinical trial methodologies, regulatory affairs, and pharmacoeconomics.
• Strong understanding of statistical principles and data analysis techniques.
• Excellent written and verbal communication skills, with the ability to present complex scientific information clearly.
• Strong project management and organizational skills.
• Ability to work effectively in a fast-paced, collaborative environment.

This challenging and rewarding position is based in Washington, D.C., US . We offer a competitive salary, comprehensive benefits, and opportunities for career advancement within a leading pharmaceutical organization.

Our client, a pioneering pharmaceutical company dedicated to advancing global health, is seeking a highly experienced and innovative Lead Clinical Research Scientist to join their esteemed team. This role is based in **Washington, D.C., US**, with a hybrid work arrangement, allowing for a blend of in-office collaboration and remote flexibility. You will play a crucial role in the design, execution, and interpretation of clinical trials, contributing significantly to the development of life-changing therapeutics. This position requires a deep understanding of clinical research methodologies, regulatory requirements, and data analysis within the pharmaceutical landscape.

Responsibilities:

• Lead the design and development of clinical trial protocols, ensuring scientific rigor, ethical considerations, and regulatory compliance.
• Oversee the execution of clinical trials, including site selection, investigator engagement, and data monitoring.
• Analyze and interpret complex clinical data, drawing meaningful conclusions to inform drug development strategies.
• Prepare scientific publications, regulatory submission documents, and internal reports.
• Collaborate with cross-functional teams, including biostatistics, data management, regulatory affairs, and medical affairs.
• Provide scientific expertise and guidance to clinical development teams and external collaborators.
• Stay abreast of the latest scientific advancements, therapeutic areas, and competitive intelligence.
• Ensure adherence to Good Clinical Practice (GCP) guidelines and all applicable regulatory requirements.
• Manage and mentor junior scientists and research associates within the clinical research department.
• Contribute to the strategic planning and portfolio management of clinical development programs.

Qualifications:

• Ph.D. or M.D. in a relevant scientific discipline (e.g., Pharmacology, Biology, Medicine).
• Minimum of 8 years of progressive experience in clinical research within the pharmaceutical or biotechnology industry.
• Demonstrated experience in designing and managing Phase II and Phase III clinical trials.
• Expertise in statistical analysis of clinical data and interpretation of results.
• Strong understanding of regulatory frameworks (e.g., FDA, EMA) and GCP guidelines.
• Excellent written and verbal communication skills, with a proven ability to publish and present scientific findings.
• Strong leadership and project management skills, with the ability to lead diverse teams.
• Experience working in a hybrid work environment, demonstrating effectiveness in both remote and in-office settings.
• Proven ability to collaborate effectively with internal and external stakeholders.
• Experience in the specific therapeutic area relevant to the client's pipeline is highly desirable.

This role offers a challenging and rewarding career path in a dynamic pharmaceutical setting, contributing to significant advancements in patient care. The hybrid model provides an optimal balance for focused work and collaborative engagement within **Washington, D.C., US**.

Our client, a globally recognized leader in pharmaceutical research and development, is actively searching for a Lead Clinical Research Scientist specializing in Oncology to join their esteemed scientific team based in **Washington, D.C., US**. This pivotal role involves leading and contributing to the design, execution, and interpretation of complex clinical trials for novel cancer therapies. You will be at the forefront of discovering and developing life-saving treatments, working with a multidisciplinary team of clinicians, statisticians, regulatory affairs specialists, and project managers. Key responsibilities include developing clinical trial protocols, authoring investigational new drug (IND) applications, and preparing scientific publications and regulatory submissions. You will also be responsible for interpreting clinical data, providing scientific leadership, and contributing to the overall drug development strategy. The ideal candidate will have a Ph.D. in a relevant life science discipline (e.g., Molecular Biology, Pharmacology, Immunology, Medicine) with a minimum of 7 years of progressive experience in clinical research within the pharmaceutical or biotechnology industry, with a specific focus on oncology. Demonstrated success in leading clinical development programs and a deep understanding of regulatory requirements (FDA, EMA) are essential. Strong scientific acumen, excellent written and verbal communication skills, and the ability to effectively present complex scientific information are required. Experience with data analysis, biostatistics principles, and a thorough knowledge of Good Clinical Practice (GCP) guidelines are also critical. This role requires a highly motivated individual with a passion for advancing cancer care and a proven track record of scientific excellence. While this position is based in our state-of-the-art facilities in **Washington, D.C., US**, requiring on-site presence, it offers unparalleled opportunities for career advancement and to make a significant impact in the fight against cancer. We provide a competitive compensation package, including salary, bonuses, and comprehensive benefits, along with a stimulating work environment.