Jobs · Research

Clinical Development Director, Obesity/Cardiovascular

Amgen · United States · 1 mo ago
RemoteRemoteResearchFull-time
We need to output HTML fragment with sections: headings

for sections like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We must only include sections when posting has real specific content. We must not repeat job title as heading. Must not include Job ID etc. Must preserve all substantive info, not invent or summarize away detail. Remove boilerplate: cookie/navigation/legal/EEO/equal-opportunity/scam-warning, duplicated lines, application instructions. Also remove "Apply now..." etc? That's application instructions, should be removed. Also remove "Refer to the Work Location Type..." etc. Also remove "In any materials you submit..." etc. Also remove "Application deadline..." etc. Also remove "Sponsorship..." etc. Also remove EEO statement. Also remove "Please contact us to request accommodation." etc. We need to extract substantive content: mission paragraph, description of role, responsibilities list, qualifications (basic and preferred), what you can expect (benefits, salary range, total rewards). Also maybe "What We Expect Of You" includes basic and preferred qualifications. "What You Can Expect Of Us" includes benefits and salary. We need to decide sections: About the role (maybe mission/intro). Responsibilities (list of duties). Requirements (maybe basic qualifications). Qualifications (preferred?). Skills (maybe communication etc). Benefits (total rewards). Pay (salary range). Schedule (maybe flexible work models). However we must only include sections if there is real specific content. The posting includes salary range statement: "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..." It does not give actual numbers, just says range is posted. That's vague but it's still mention of salary range. The instruction: never create Pay/Schedule/Benefits sections unless the posting actually states them. It does state salary range is posted (though not numbers). It also mentions benefits: comprehensive employee benefits package etc. So we can include Benefits and Pay sections. Schedule: mentions flexible work models where possible. That's somewhat specific. Could include Schedule. We must not include placeholder like "commensurate with experience" etc. The posting does not have those. It says "Actual salary will vary based on several factors..." that's okay. We need to output only HTML fragment, no /, no markdown fences. We'll produce something like:

About the role

...

Responsibilities

  • ...
  • ...

Requirements

  • MD or DO degree from an accredited medical school AND 3 years of clinical research experience

Qualifications

  • Three (3) or more years of clinical research experience in the biopharmaceutical industry...
  • ...
Maybe combine basic and preferred into Requirements and Qualifications? The instruction: use headings for sections like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. So we can have Requirements for basic qualifications, Qualifications for preferred, Skills for communication etc. Benefits, Pay, Schedule. We need to preserve all substantive info; not invent or summarize away detail. So we must include each bullet point exactly as in text, not paraphrase? We can keep the wording but maybe trim unnecessary fluff? Must not invent or summarize away detail; we can keep the content but can we rephrase? Safer to keep the original sentences/phrases. Let's extract: Mission/intro paragraph: "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. 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, 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." That's about the role? Could be About the role. Responsibilities: bullet list under "What You Will Do". Let's extract each sentence after that heading. The text: "What You Will Do Let’s do this. Let’s change the world. Amgen is advancing our Obesity and Cardiometabolic pipeline. We need collaborative and innovative world-class talent to ensure these molecules become medicines and reach their full potential while helping patients. The Obesity Therapeutic Area is seeking a Clinical Development Director to play a vital role on one or more late phase studies within the maridebart cafraglutide (AMG 133) global development program in obesity and related metabolic diseases. In this role, you will report directly to the Global Development Lead for cardiovascular indications. Provide clinical/scientific knowledge into the development, design, delivery and communication of the global evidence generation plan for maridebart cafraglutide (AMG 133) phase 3 program(s).Work cross functionally within teams to ensure clinical strategy is translated into the development of the study concept document, study protocol and related documentsProvide clinical input into & implementation of clinical trial(s), their delivery, clinical data review, interpretation of results.Serve as medical monitor for ongoing clinical trialsReview and analyze clinical trial data to ensure accuracy, completeness and adherence to protocol and regulatory requirementsParticipate and provide clinical input into safety and regulatory interactionsAuthor clinical study reports, publications and regulatory submissionsDevelop relationships with key opinion leaders and make scientific presentations at advisory boards, key scientific meetings and external committee meetings as delegated by Global Development Lead" We need to split into list items. Each responsibility seems separated by a period but some are concatenated without spaces. We'll need to parse. Let's list: - Provide clinical/scientific knowledge into the development, design, delivery and communication of the global evidence generation plan for maridebart cafraglutide (AMG 133) phase 3 program(s). - Work cross functionally within teams to ensure clinical strategy is translated into the development of the study concept document, study protocol and related documents - Provide clinical input into & implementation of clinical trial(s), their delivery, clinical data review, interpretation of results. - Serve as medical monitor for ongoing clinical trials - Review and analyze clinical trial data to ensure accuracy, completeness and adherence to protocol and regulatory requirements - Participate and provide clinical input into safety and regulatory interactions - Author clinical study reports, publications and regulatory submissions - Develop relationships with key opinion leaders and make scientific presentations at advisory boards, key scientific meetings and external committee meetings as delegated by Global Development Lead Also earlier sentences: "Amgen is advancing our Obesity and Cardiometabolic pipeline. We need collaborative and innovative world-class talent to ensure these molecules become medicines and reach their full potential while helping patients. The Obesity Therapeutic Area is seeking a Clinical Development Director to play a vital role on one or more late phase studies within the maridebart cafraglutide (AMG 133) global development program in obesity and related metabolic diseases. In this role, you will report directly to the Global Development Lead for cardiovascular indications." Those could be part of responsibilities or role description. Might be better to include them under About the role or Responsibilities. But we already have About the role covering mission. Could add a short paragraph about the role under About the role. However we must not duplicate. We'll keep About the role as mission/intro. Then Responsibilities list as above. Now Requirements (basic qualifications): "Basic Qualifications: MD or DO degree from an accredited medical school AND 3 years of clinical research experience" We'll output as list item. Preferred Qualifications: a paragraph with multiple bullet-like sentences. Let's extract each: "Three (3) or more years of clinical research experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company), ideally in late phase development in a cardiometabolic or adjacent therapeutic area." "Five or more years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities" "Knowledge of pharmaceutical product development, product lifecycle, and commercialization processes" "Experience 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 2 and/or 3 clinical trials in obesity, diabetes or cardiovascular indications" "Experience with clinical trial medical data review, medical monitoring and or safety review and interpretation, including use of electronic aggregate data review tools" "Experience drafting high level submission documents for regulatory submissions including authoring clinical regulatory responses for health regulatory interactions" "Strong communication & presentation skills to clearly communicate scientific 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" "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" We'll put these under Qualifications heading. Skills: maybe we could extract communication & presentation skills, interpersonal skills, problem-solving abilities. But those are already in Qualifications. Could still have Skills heading for those. But to avoid duplication, maybe we put communication etc under Skills. However the instruction says we can have Skills section. We'll decide to put communication & presentation skills, interpersonal skills, problem-solving abilities under Skills. But they also appear in Qualifications; we might duplicate. Better to keep Qualifications for experience/knowledge, and Skills for soft skills. Let's extract: From Preferred Qualifications: "Strong communication & presentation skills to clearly communicate scientific 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" Also maybe "Leadership experience/potential as a medical expert in a complex matrix environment" could be Skills or Qualifications. We'll put under Skills. Thus Skills heading with those three items. Benefits: from "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." Then list: "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 accountsA discretionary annual bonus program, or for field sales representatives, a sales-based incentive planStock-based long-term incentivesAward-winning time-off plansFlexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies." We need to extract benefits items: comprehensive employee benefits package (Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, flexible spending accounts), discretionary annual bonus program, stock-based long-term incentives, award-winning time-off plans, flexible work models where possible. We'll put under Benefits. Pay: The salary range statement: "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

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