Clinical Research Medical Director, Endocrinology/Obesity/Diabetes, US - Remote

ions.

Responsibilities:

• Provide clinical/scientific knowledge into the development, design, delivery, and communication of the global evidence generation plan for multiple metabolic assets.

• Be able to plan, provide input and guidance to clinical trials design and implementation

• Support cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the development program

• Participate and provide clinical input into safety and regulatory interactions

• Act as medical monitor during clinical trials execution.

• Interpret and communicate clinical trial data

• Oversee the authoring of clinical study reports, publications, and regulatory submissions

• Develop relationships with key opinion leaders and make scientific presentation at advisory boards, key scientific meetings and external committee meetings as delegated by Global Development Lead

• Provide clinical content input to materials to be used in Scientific Affairs as well as the Commercial Organization

• Contribute to TPP (target product profile) and Global Product Safety (GPS) development

• Create development options and present to Global Dev Review Committee (GDRC), Therapeutic Area Governance (TAG)

• Interact with TA leadership and extended team to develop strategies options

• Interact with Center for Design Analysis (CfDA), Center for Observational Research (CfOR), Clinical Pharmacology Modeling & Simulation (CPMS), etc., to bring innovative later development options.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The medical professional we seek is a leader with these qualifications:

Basic Qualifications

• MD or DO degree from an accredited medical school
  AND

• 2 years of clinical research experience and/or basic science research

Preferred Qualifications:

• Five (5) years of clinical research experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company) in obesity or obesity-related conditions.

• Eight (8) years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities

• Oversee late phase evidence generation from Phase 2 and beyond by leading the design and implementation of the Total Evidence Generation Plan (EGP), including registrational, non-registrational, and real-world evidence

• Previous experience in regulatory interactions and filing activities for Endocrinology/Diabetes/Obesity products

• Experience in biotech or pharma with developing study concepts for clinical development and clinical trial designs with cross functional input, including biostatistics, observational research and patient reported outcomes in Phase 1, 2 and/or 3 clinical trials in obesity or diabetes

• Strong and versatile clinical development experience in endocrinology and accreditation in relevant sub-specialty

• Knowledge of pharmaceutical product development, product lifecycle, and commercialization processes

• Knowledge of Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations and guidelines, and applicable international regulatory requirements

• Leadership experience/potential as a medical expert in a complex matrix environment

• Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication

• Strong interpersonal skills and problem-solving abilities while exhibiting superior judgment and a balanced, realistic understanding of issues and resolution path

They will also embody the Amgen leadership attributes which are:

• Inspire: Create a connected, inclusive, and inspiring work environment that empowers talent to thrive

• Accelerate: Enable speed that matches the urgency of patient needs by encouraging progress over perfection

• Integrate: Connect the dots to amplify the collective power of Amgen to drive results for patients, staff, and shareholders

• Adapt: Lead through change by adapting to an ever-changing environment and defining a clear course of action to deliver results

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well-being.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is $256,334. to $318,868. 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 comprising 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 including:

• 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 and bi-annual company-wide shutdowns

• Flexible work models, including remote work arrangements, where possible

Amgen's Commitment to Our Staff

At Amgen, our mission is serving patients. Our staff are dedicated to pushing the boundaries of science to transform medicine and turn the tide on serious illnesses. Central to achieving this mission is our "people-first" philosophy. We recruit the best talent, build an environment that facilitates career growth, and provide staff with the opportunity to make significant contributions for patients and our business.

We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions.

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

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.

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.

#obesity

Salary Range
261,969.00 USD - 329,723.00 USD