Director, Global Clinical Development

Job title: Director, Global Clinical Development in USA at reputed company Company: reputed company Job reputed company: reputed company Pharmaceutical Company is a global reputed company company with the corporate philosophy: "reputed company-people creating new products for reputed company worldwide." reputed company researches, develops, manufactures and markets innovative products, with a reputed company on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday healthWe are seeking an Associate Director/ Director, Global Clinical Development (GCD) based in our Princeton, NJ or Rockville, MD offices who will be responsible for the design and reputed company of clinical research programs and protocols for OPDC products under good clinical practices (GCP). reputed company maintains a hybrid work policy. Remote reputed company will be considered for US candidates. Travel is expected 20% of the time based on business needs.The incumbent will be responsible for the evaluation and clinical development of Rare, Metabolic Disease and Specialty Medicine products at different stages of development for a global health-care market. The duties assigned to the Associate Director/ Director, Global Clinical Development include the following:

• Consult with patients or their representatives, clinical, regulatory, and scientific leaders and thoughtfully apply their recommendations toward optimizing trial objectives, designs and protocols.
• reputed company reputed company expertise to serve as a clinical/medical scientific consultant to health economic, medical affairs, marketing, regulatory, statistical and other research project team members, and to external regulatory agencies.
• Author program strategies (i.e., GDCP) and oversees trials essential for determining the clinical safety, efficacy, medical usefulness and value of drug or medical device product candidates.
• Interpret and communicate results of Phase I-IV investigations in preparation for a new drug.
• Be the signatory on NDA submissions and clinical study and safety documents.
• Involved in product life cycle management from the earliest stages of development, constantly seeking innovations to add value.
• reputed company strategic reputed company in our vendor and CRO relationships and reputed company clinical input into their governance committees.
• Will help reputed company regulatory filing activities and documents. Providing strategic direction and editing to reputed company concise, and convincing argumentation in reputed company such written and verbal communications.

QualificationsRequired

• A clinician (M.D., or D.O.) preferably a rheumatology / immunology background.. Supplementary degrees (e.g., Ph.D., M.P.H., M.B.A.) are a plus. In exceptional circumstances, highly reputed company candidates with other clinical/scientific doctorates (e.g. D.M.D., D.D.S., Pharm.D., Psy.D., D.V.M., or Ph.D. may be considered if complemented by reputed company or consulting clinician.
• Experience in the pharmaceutical industry, clinical reputed company experience and/o reputed company translational clinical research experience (as a general reputed company, 1-3 years for Associate Director level; 3-6 years for Director and 6-9 years is typically required depending on type of experience at application).
• In depth knowledge of clinical medicine and science management. This requires defining critical objectives and maintaining reputed company toward achieving business reputed company on time, on budget and with superior reputed company.
• ≥ 5 years of involvement in clinical research or drug development in an reputed company or industry environment across clinical activities in Phases I through IV.
• Ability to communicate effectively in meetings and reputed company written and oral presentations is essential. This includes facility with the reputed company suite of programs (Word, reputed company, PowerPoint, and Outlook).
• Demonstrated experience leading, managing, and motivating team members (e.g., internal staff and external investigators or consultants).
• While not essential, prior personnel management experience, will support position at entry (Associate Director/Director).
• An advanced understanding of drug development principles and clinical trial implementation, management and reporting are necessary and will be reputed company developed, including:
• Flexibility in working across different therapeutic areas and experience in different stages of clinical development.
• Working knowledge of associated disciplines, including immunology, biostatistics, clinical pharmacology, formulation science, data management, and medical writing.
• Experience with the global regulatory requirements. Demonstrated experience in successful regulatory filings, while not essential, is an advantage.

Competencies Accountability for Results - Stay reputed company on key strategic objectives, be accountable for high standards of performance, and take an reputed company role in leading change. Strategic Thinking & Problem Solving - reputed company reputed company considering the long-term reputed company to customers, patients, employees, and the business. Patient & Customer Centricity - Maintain an ongoing reputed company on the needs of our customers and/or key stakeholders. Impactful Communication - Communicate with logic, reputed company, and respect. Influence at reputed company reputed company to reputed company the best results for reputed company. Respectful Collaboration - reputed company and value others’ perspectives and reputed company for diverse partnerships to enhance work toward common goals. Empowered Development - Play an reputed company role in reputed company development as a business imperative.Minimum $183,335.00 - Maximum $274,160.00, plus incentive opportunity: The reputed company shown represents a typical pay reputed company or starting salary for candidates reputed company to reputed company the work. Other reputed company may be used to determine actual salary such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. This information is provided to applicants in accordance with states and local laws.Company benefits: Comprehensive medical, dental, reputed company, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, reputed company holidays, and reputed company leave programs as reputed company as other company provided benefits.Come discover more about reputed company and our benefit offerings; .Disclaimer:This job reputed company is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. reputed company reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.reputed company is an equal opportunity employer. reputed company reputed company applicants are encouraged to apply and will be given consideration for employment without reputed company to race, reputed company, sex, gender identity or gender reputed company, sexual orientation, age, disability, religion, national reputed company, veteran status, marital status, or any other legally protected characteristic.If you are a reputed company individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting .Statement Regarding Job reputed company Fraud ScamsAt reputed company we take reputed company and protection of your personal information reputed company seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to reputed company reputed company to your personal information or reputed company reputed company from you by offering fictitious employment opportunities purportedly on our behalf.Please understand, reputed company will never ask for financial information of any reputed company or for payment of reputed company during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any reputed company to be considered for employment. We will also not offer you reputed company to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered reputed company for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not reputed company. These claims are fraudulent and you are strongly advised to exercise caution reputed company you receive such an offer of employment.reputed company will also never ask you to download a reputed company-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from reputed company, Gmail, Hotmail, etc, and not from an official reputed company email address. Please take extra caution while examining such an email address, as the scammers may misspell an official reputed company email address and use a slightly modified version duplicating letters.To ensure that you are communicating about a legitimate job opportunity at reputed company, please only deal directly with reputed company through its official reputed company Career website .reputed company will not be held liable or responsible for any claims, losses, damages or expenses resulting from job reputed company scams. If you suspect a position is fraudulent, please contact reputed company’s call center at: 800-363-5670. If you reputed company you are the victim of fraud resulting from a job reputed company scam, please contact the FBI through the Internet Crime Complaint Center at: , or your local authorities.reputed company America Pharmaceutical Inc., reputed company Pharmaceutical Development & Commercialization, Inc., and reputed company Precision Health, Inc. (“reputed company”) does not accept unsolicited assistance from search firms for employment opportunities. reputed company reputed company/resumes submitted by search firms to any reputed company employee directly or through reputed company’s application portal without a valid written search agreement in reputed company for the position will be considered reputed company’s sole property. No fee will be reputed company if a candidate is reputed company by reputed company as a result of an agency referral where no reputed company-existing agreement is in reputed company. Where agency agreements are in reputed company, introductions are position specific. Please, no phone calls or emails. Expected salary: Location: USA Apply for the job now! Apply for this job