Senior Vice President, Drug Development

31 May 2024

Vacancy expired!

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.Summary:The overall responsibility of the SVP, Drug Development is to provide strategic, visionary leadership and tactical expertise throughout the clinical development process in a highly collaborative and global environment.Position Responsibilities:

Drive an innovative field of multiple therapeutic areas for broad disorders; creative thinker and implementer.

Work across therapeutic modalities including plasma fractions, small molecules and medical devices, unconstrained by the specifics, open to the best approaches.

Be responsible for the creation and execution of clinical development plans, protocols, data analyses, clinical study reports, and other related clinical documents that are derived from the company’s deep scientific understanding of the aging plasma proteome

Serve as the external representative of Grifols’ clinical program in interactions with development partners, CROs, the FDA, and clinical consultants.

Develop strong, collaborative networks with other internal and external functional leaders including translational medicine, clinical operations and pharmacovigilance, to enable efficient project planning and execution

Lead studies/programs at all stages of clinical development including, but not limited to, first in man studies and randomized, global trials

Collaborate in the preparation of INDs, BLAs/NDAs, and Investigator Brochures.

Author, contribute and/or review clinical sections of regulatory documents, external communications, etc.

Collaborate (as needed) with consultants (such as statistician and other experts) to assure successful study design methodology, statistical analysis plans, data management, trial results, etc.

Author and execute clinical development plans (CDP) for product candidates.

Lead clinical advisory boards and investigator meetings

Be current in clinical trials methodology and responsible for the interpretation of overall clinical study outcomes

Provide clinical input and collaboration in business development activities, including due diligence and partnering meetings.

Actively engage and participate in cross functional collaborative teams such as (but not limited to) the iTags.

Lead strategic development and due diligence of potential new indications and clinical therapies, based on scientific results generated from the Company’s preclinical research

Report to the Chief Scientific Innovation and manage an internal clinical development team

Education:A Doctor of Medicine (MD) is requiredExperience:Minimum 10 years’ experience in design, execution and evaluation of clinical trials and new product submission documents, either in the specialty pharmaceutical or biopharmaceutical industry is essential.Knowledge, Skills & Abilities:

In depth understanding of pharmaceutical regulatory requirements and their impact on development of clinical trials and NDAs.

Demonstrated knowledge of international clinical pharmaceutical standards, ICH/GCP guidelines, and regulatory requirements

Must have experience developing and editing FDA briefing books and attending meetings

Must have extensive experience overseeing CROs, central laboratories, and other clinical study vendors with a track record of bringing studies to completion on time and within budget.

Effective leadership skills and proven ability to foster team productivity and cohesiveness. Demonstrated experience managing and mentoring clinical team members, and overseeing team of external consultants

A collaborative team player with a personal style that is collegial, flexible and forward- thinking, with a “work smarter” approach

Enjoys problem solving and possesses the ability to address issues arising from a medical, regulatory and clinical trial perspective

Excellent people interaction and communication skills, strong professional diplomacy and positive attitude a must

Able to engage in work-related travel when required

Pay Scale:The estimated pay scale for the Senior Vice President, Drug Development role based in the United States (Non-California), is $343,000.00 - $450,000.00 per year. Additionally, the position is eligible to participate in up to 30% of the company bonus pool. We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, PTO, 9 paid Holidays per year, up to 5% 401(K) match and tuition reimbursement. Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data. We are committed to offering our employees opportunities for professional growth and career progression. Grifols is a global healthcare organization with employees in 30 countries focused on patient health and providing impactful results. Since our humble beginnings in 1909, Grifols has been a family company that prides itself on its family-like culture. Our company has more than tripled over the last 10 years, and you can grow with us!For Washington State:Currently, the first year PTO accrual for this role is 160 hours per year. Then, after completion of 365 days of employment, the PTO accrual for this role will increase to 180 hours per year.For California:The estimated pay scale for the Senior Vice President, Drug Development role based in California, is $394,000- $520,000.00 per year.EEO Minorities/Females/Disability/VeteransGrifols is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and local laws that prohibit employment discrimination on the basis of race, color, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability or veteran's status or any other classification protected by applicable State/Federal laws.Learn more about Grifols (http://www.grifols.com/es/web/international/home)Req ID: 502810Type: Regular Full-TimeJob Category: Research & Development

Full-time
  • ID: #50028685
  • State: Colorado Ftcollins 00000 Ftcollins USA
  • City: Ftcollins
  • Salary: USD TBD TBD
  • Showed: 2023-05-31
  • Deadline: 2023-07-31
  • Category: Et cetera