Medical Director, Clinical Development
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Job Location:
Gentofte Kommune - Denmark
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Would you enjoy leading drug development for rare conditions Are you a medic with experience designing clinical trials and interacting with regulatory authorities
If so now is your chance to join Ascendis Pharma as our new Medical Director Clinical Development Endocrine & Rare Diseases
Ascendis Pharma is a global biopharmaceutical company committed to making a meaningful difference in patients lives. Guided by our core values of Patients Science and Passion we are applying our innovative TransCon technology platform to fulfill our mission of developing new therapies that demonstrate best-in-class potential to address unmet medical needs.
At our headquarters in Hellerup Denmark research facilities in Heidelberg Germany and additional offices across Europe and the United States we are advancing programs in our Endocrinology Rare Disease and Oncology portfolios. We also collaborate with partners on the development of TransCon-based products in other therapeutic areas and markets.
We are seeking an energetic Medical Director to join our growing team. As a key member of the Ascendis Pharma team you will play a crucial role in driving the design safety monitoring and data analysis of the Companys late-phase clinical trials studying TransCon C-type natriuretic peptide (CNP). This is an exciting opportunity to work in a fast-paced environment collaborate with cross-functional global teams working together to achieve extraordinary results.
You will report directly to the VP Clinical Science Endocrine and Rare Disease Medical Sciences.
Your key responsibilities will be
- 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
Qualifications and Skills:
- M.D. degree
- Ph.D. degree (strongly preferred)
- Hands-on experience treating patients
- At least 10 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).
- Strong track record of scientific and clinical inquiry
- Possess excellent communication skills (written and oral)
- Demonstrate sound judgement in terms of handling complex confidential and regulated information
Key competencies:
You have excellent communication skills both written and verbal and you learn quickly even when working under pressure. Youre able to follow complex instructions multitask effectively and still maintain a strong attention to detail. You lead confidently both through your actions and when guiding others and youre known for being a trustworthy collaborative team player. You take initiative solve complex problems with ease and demonstrate sound judgment especially when handling confidential sensitive or regulated information
Travel: Up to 20%.
Office: Ascendis Pharma Headquarters Tuborg Boulevard 12 2900 Hellerup Denmark
Apply now.
Applications will be evaluated when received so please apply as soon as possible.
All applications must be submitted in English and are treated confidentially.
A note torecruiters:
Wedo notallowexternalsearchparty ofcandidateswithoutwrittenpermission from the Ascendis PharmaHR team(specificallyfrom: TalentAcquisitionPartner or Human ResourcesDirector) is .
Required Experience:
Director
Key Skills
- EMR Systems
- Post Residency Experience
- Occupational Health Experience
- Clinical Research
- Managed Care
- Primary Care Experience
- Medical Management
- Utilization Management
- Clinical Development
- Clinical Trials
- Leadership Experience
- Medicare
About Company
Founded in Copenhagen, Denmark in 2007, Ascendis Pharma is a publicly held, biopharmaceutical company committed to addressing unmet medical needs. Ascendis Pharma is applying its innovative platform technology to build a leading, fully integrated biopharma company focused on making a ... View more
