Clinical Scientist - Job ID: 1915

Ascendis Pharma; Palo Alto (CA); Sur place; USD 160 000 - 180 000; Plein temps

Avantages offerts par ce poste

401(k) plan with company match

Medical, dental, and vision plans

AD&D insurance

Disability benefits

Pet Insurance and Legal Insurance

Employee Assistance Program

Employee Discounts

Professional Development

HSA

Résumé du poste

Ascendis Pharma is seeking a Senior Clinical Scientist to join our US Clinical Development team. The role involves design, monitoring, and data analysis for late-phase trials in growth hormone, parathyroid hormone, and C-type natriuretic peptide programs.

Hybrid work from Palo Alto with potential remote arrangement for the right candidate. The position requires an advanced degree and a proven track record in trial design, data interpretation, and regulatory submissions.

Qualifications

• Advanced degree e.g. Ph.D., Pharm.D., MS, or equivalent.
• Strong track record of scientific and clinical inquiry.
• Understand statistical concepts and clinical trial design.
• Understand the connection between nonclinical data and clinical data.
• Possess excellent communication skills (both written and verbal).
• Learn quickly, follow complex directions under pressure.
• Multi-task while remaining organized and attentive to detail.
• Work hard, be a trustworthy and collaborative team player.
• Take initiative and solve problems of moderate complexity.
• Demonstrate sound judgement in terms of handling complex, confidential, and regulated information.
• Lead both directly and by example.

Responsabilités

• Design, monitor, and support site and subject retention in clinical trials.
• Ensure completion of documents (protocols, brochures, monitoring plans, training materials, study reports, responses, SOPs) with cross-functional teams.
• Participate on study teams and cross-functional teams as delegated by VP, Clinical Development.
• Maintain consistency of language and criteria across endocrine projects.
• Ensure study integrity and track safety and efficacy data.
• Anticipate obstacles in trials and implement solutions.
• Analyze, evaluate, and support interpretation and reporting of clinical data.
• Contribute to drafting and reviewing clinical documents, manuscripts, and regulatory submissions.
• Maintain up-to-date knowledge of science, medical information, GCP, and regulatory guidance.
• Collaborate with cross-functional colleagues to optimize product development.

Connaissances

Clinical trial design

Statistical concepts

Excellent communication

Cross-functional collaboration

Leadership

Formation

Advanced degree (PhD/PharmD/MS)

Description du poste

Ascendis Pharma is a dynamic, fast-growing global biopharmaceutical company with locations in Denmark, Europe, and the United States. Today, we're advancing programs in Endocrinology Rare Disease and Oncology.

Here at Ascendis, we pride ourselves on exceptional science, visionary leadership, and skilled and passionate colleagues.

Guided by our core values of Patients, Science, and Passion, we use our TransCon® drug development platform to fulfill our mission of developing new and potentially best-in-class therapies to address unmet medical needs.

Our culture fosters a place where skilled, adaptable, and highly resourceful professionals can truly make their mark. We offer a dynamic workplace for employees to grow and develop their skills.

The Clinical Scientist is involved in the design, monitoring, and data analysis of the Company's late-phase clinical trials studying growth hormone, parathyroid hormone, and/or C-type natriuretic peptide therapies. As such, the Senior Clinical Scientist is an important and visible member of the Clinical Development team. The Senior Clinical Scientist position is based in the United States ideally the Scientist will work hybrid from our Palo Alto, CA office but we may consider a remote arrangement for the right candidate.

Key Responsibilities

• For clinical trials: design, provide oversight, and support site and subject retention
• Ensure successful completion of documents (including clinical trial protocols, investigator brochures, monitoring plans, site training materials, clinical study reports, health authority responses, standard operating procedures, etc.) with cross-functional team members
• Participate on study teams and cross-functional teams as appropriate, and as delegated by the Vice President, Clinical Development
• Ensure consistent use of language and criteria across multiple endocrine projects
• Ensure study integrity, and track accumulating safety and efficacy data
• Anticipate obstacles within a clinical trial, and implement solutions
• Analyze, evaluate, and support accurate interpretation and reporting of clinical data
• Contribute to drafting and reviewing clinical documents, manuscripts, presentations, and regulatory submissions
• Maintain up-to-date knowledge of relevant science, medical information, good clinical practices, and regulatory guidance
• Collaborate with-and serve as a clinical research resource for-cross-functional colleagues to optimize product development
• Cultivate relationships with investigative sites, clinical consultants, and key opinion leaders to represent the interests of the company
• Support corporate strategic and organizational initiatives
• Assist with commercial activities as needed
• Complete assigned tasks thoroughly, accurately, and on time
• Adhere to rigorous ethical standards
• Travel up to 20% domestically and internationally for scientific meetings

Requirements

• Advanced degree e.g. Ph.D., Pharm.D., MS, or equivalent
• Strong track record of scientific and clinical inquiry
• Understand statistical concepts and clinical trial design
• Understand the connection between nonclinical data and clinical data
• Possess excellent communication skills (both written and verbal)
• Learn quickly, follow complex directions under pressure
• Multi-task while remaining organized and attentive to detail
• Work hard, be a trustworthy and collaborative team player
• Take initiative and solve problems of moderate complexity
• Demonstrate sound judgement in terms of handling complex, confidential, and regulated information
• Lead both directly and by example
• Preferred, but not required:
  • At least 4 years of experience with clinical trial design and execution
  • At least 4 years of pharmaceutical industry experience
  • Experience with regulatory submissions and interactions

The estimated salary range for this position is $160-180K/year USD DOE. Actual salary determination is dependent on a variety of factors some of which include: experience, qualifications, and geographic location. This position may be eligible for a discretionary annual bonus or an incentive compensation plan (eligibility varies based on role and position level), discretionary stock-based long-term incentives, paid time off, and a comprehensive benefits package.

Benefits

• 401(k) plan with company match
• Medical, dental, and vision plans
• Company-offered Life and Accidental Death & Dismemberment (AD&D) insurance
• Company-provided short and long-term disability benefits
• Unique offerings of Pet Insurance and Legal Insurance
• Employee Assistance Program
• Employee Discounts
• Professional Development
• Health Saving Account (HSA)
• Flexible Spending Accounts
• Various incentive compensation plans
• Accident, Critical Illness, and Hospital Indemnity Insurance
• Mental Health resources
• Paid leave benefits for new parents