Medical Director, Clinical Development - Job: MDCD
Medical Director, Clinical Development - Job: MDCD
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Job Description
Ascendis Pharma is a dynamic fast-growing global biopharmaceutical company with locations in Denmark Europe and the United States. Today were 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 monitoring data analysis and interpretation 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 Science.
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
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 years 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
Travel up to 20% domestically and internationally for scientific meetings.
Salary range: $265-295K/year
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
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.
Required Experience:
Director
Employment Type
Full-Time
