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Description

Medical Director, Clinical Development, Endocrine and Rare Diseases - Job ID: 1442

Ascendis Pharma isa 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 Medical Director is involved in the design, safety monitoring, and data analysis of the Companys late-phase clinical trials in endocrinology. As such, the Medical Director is an important and visible member of the clinical development team. The Medical Director position is based in the United States (preferably in Palo Alto, California) and will report to the Vice President, Clinical Development.

Key Responsibilities

Contribute to formulation and implementation of the Clinical Development Plan

Leverage medical expertise and hands-on clinical experience to promote relevance and rigor of the development program

For clinical trials: design, provide overall oversight, and support site and subject retention

Serve as a Medical Monitor for clinical trials, ensure study integrity, and track accumulating safety and efficacy data

Provide leadership to teams of medical monitors

Provide leadership to study teams

Ensure successful completion of trial-related documents (including clinical trial protocols, investigator brochures, medical monitoring plans, site training materials, clinical study reports, health authority responses, standard operating procedures, etc.) with cross-functional team members

Ensure study integrity, and track accumulating safety and efficacy data

Analyze, evaluate, interpret, and report clinical data

Anticipate and solve complex drug development problems

Contribute to regulatory strategy

Contribute to drafting and reviewing of clinical documents, manuscripts, presentations, and regulatory submissions

Maintain up-to-date knowledge of relevant science, medical information, good clinical practices, and regulatory guidance

Collaborate withand serve as a clinical research resource forcross-functional colleagues (e.g. in clinical operations, statistics, regulatory affairs, medical affairs, health economics outcomes research, commercial, finance) to optimize product development

Contribute to (and may be asked to represent the clinical development department in) corporate strategic and organizational initiatives

Cultivate relationships with investigative sites, clinical consultants, and key opinion leaders to represent the interests of the company

Assist in portfolio management and 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 :::

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Requirements

Knowledge, Skills and Experience

M.D. degree

Completion of ACGME-accredited residency and fellowship (strongly preferred)

Physician licensure in at least one state (strongly preferred)

Board-certified (strongly preferred), with specialty in endocrinology highly desired

At least 5 years of industry experience (other relevant experience e.g. post-graduate experience in the clinical and/or academic realms may also be considered on a case-by-case basis). Those with less experience may be considered for an Associate Medical Director position.

At least 3 y ars of experience with clinical trial design and execution

Strong track record of scientific and clinical inquiry

Possess excellent communication skills (written and oral)

Learn quickly, follow complex directions under pressure

Multi-task while remaining organized and attentive to detail

Lead both directly and by example

Work hard, be a trustworthy and collaborative team player

Take initiative and solve complex problems

Demonstrate sound judgement in terms of handling complex, confidential, and regulated information

Salary range: $265-285K/year

A note to recruiters:

We do not allow external search party solicitation. Presentation of candidates without written permission from the Ascendis Pharma Inc Human Resources team (specifically from: Talent Acquisition Partner or Human Resources Director) is not allowed. If this occurs your ownership of these candidates will not be acknowledged. :::

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Benefits

• Medical insurance
• Vision insurance
• Dental insurance
• 401(k)
• Paid maternity leave
• Paid paternity leave
• Commuter benefits
• Disability insurance :::