Job Information
Ascendis Pharma, Inc. Medical Director, Clinical Development, Endocrine - Job ID: 1442 in Palo Alto, California
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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 :::