Clinical Development Director- Cardiovascular

At Amgen if you feel like youre part of something bigger its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980 weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology Inflammation General Medicine and Rare Disease we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer heart disease inflammatory conditions rare diseases and obesity and obesity-related conditions. As a member of the Amgen team youll 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 youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Clinical Research Medical Director

Lets do this. Lets change the this vitalroleyou willlead medical and clinical development activities for assets within the General Medicine therapeutic area. This role is accountable for clinical strategy study-level medical leadership cross-functional decision-making and support of program execution from early clinical development through late-stage studies depending on portfolio need. The role partners closely with Clinical Operations Regulatory Safety Biostatistics Medical Affairs Data Management and other functional teams to advance programs with scientific rigor patient focus and operational discipline.

Key Responsibilities

• Provide clinical and medical leadership for one or more General Medicine programs or studies.

• Support the development execution and communication of global clinical development and evidence-generation strategies for cardiovascular assets across all stages of development.

• Collaborate with cross-functional global teams to integrate medical scientific regulatory commercial and market access perspectives into development programs.

• Build andmaintainstrategic scientific relationships with key opinion leaders academic investigators cardiovascular societies and external experts.

• Provide clinical and scientific leadership in the design conduct analysis and interpretation of clinical trials.

• Contribute to the authoring and review of clinical documents including protocols investigator brochures clinical study reports briefing books safety narratives and regulatory responses.

• Contribute clinicalexpertiseto safety evaluations risk-benefit assessments and pharmacovigilance activities.

• Participate in regulatory interactions and support submissions to global health authorities including FDA EMA PMDA and other regulatory agencies.

• Interpret clinical trial results and contribute to data-driven development decisions.

• Present scientific and clinical data at advisory boards steering committees investigator meetings scientific congresses and other external forums as delegated by the Global Development Leader.

• Identifyemerging scientific opportunities and unmet medical needs in cardiovascular medicine to inform future development strategies.

• Contribute to lifecycle management strategies including label expansion opportunities and new cardiovascular indications.

• Provide clinical content and strategic input for:

• Regulatory submissions and agency interactions

• Safety assessments and governance reviews

• Medical Affairs and Scientific Affairs materials

• Health economics and outcomes research initiatives

• Commercial and market access strategies

What we expect of you

We are all different yet we all use our unique contributions to serve patients. The clinical development professional weseekhas these qualifications.

Basic Qualifications

MD or DO degree from an accredited medical school

AND

2 years of clinical development experience.

Preferred Qualifications

• MD or equivalent medical degree.

• 5 years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities in cardiovascular disease.

• Clinical research experience in the biopharmaceutical industry (biotechnology pharmaceutical or CRO environment).

• Demonstrated experience in clinical development translational medicine medical affairs or relateddrug-developmentfunctions.

• Strong working knowledge of clinical trial design execution and interpretation biostatistics adaptive trial methodologies and evidence-generation strategies.

• Proven ability to work across matrixed teams and influence without direct authority.

• Strong understanding of cardiovascular clinical endpoints biomarkers imaging modalities and contemporary treatment guidelines.

• Sound scientific and clinical judgment with the ability to evaluate complex benefit-risk profiles.

• Working knowledge of Good Clinical Practice (GCP) FDA EMA/CHMP regulations ICH guidelines and global regulatory requirements.

• Excellent written and verbal communication skills including the ability to communicate complex scientific concepts to diverse audiences.

• Demonstrated success functioning as a medical leader within a highly matrixed global organization.

• Strong strategic thinking problem-solving and decision-making capabilities witha track recordof delivering results in complex development programs.

• Ability to influence without authority and effectively collaborate across functions regions and external stakeholders.

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 well 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 where possible. Refer to the Work Location Type in the job posting to see if this applies.

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.

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.

Sponsorship for this role is not guaranteed.

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.

Salary Range