Clinical Development Medical Director – Breast Cancer (897233-GBA)
- Experience Level
- Experienced (non-manager)
Our client is a leading global player in the Pharmaceutical industry with global headquarters in Basel, Switzerland. They are undergoing a transformation with respect to culture and outside perception. The organisation focusses on novel therapies in Oncology and Ophthalmology and is also currently developing a world-leading pipeline in Neuroscience and Dermatology with one of the strongest pipelines of Phase II/III studies in the world.
We are currently looking for a Clinical Development Medical Director – Breast Cancer to be based in Basel for a contract position with good possibilities to be extended.
- Provides clinical leadership and medical strategic input for all clinical deliverables in the assigned project or section of a clinical program if applicable. Clinical deliverables may include clinical sections of individual protocols consistent with the Integrated Development Plans (IDP), clinical data review, program specific standards, clinical components of regulatory documents/registration dossiers, and publications
- Leads development of clinical sections of trial and program level regulatory documents (e.g., Investigator’s Brochures, briefing books, safety updates, submission dossiers, and responses to Health Authorities)
- Drives execution of the section of the clinical program in partnership with global line functions, assigned Global Trial Directors (GTDs), and regional/country medical associates if applicable
- Oversees/conducts ongoing medical and scientific review of clinical trial data with Clincal Scientific Expert(s)
- May be the Program Manager of other associates (e.g.., CSE).
- May act as study medical monitor
- Supports (Sr.) GPCH in ensuring overall safety of the molecule for the assigned section, may be a core member of the Safety Management Team (SMT), and supports overall program safety reporting (e.g., Periodic Safety Update Reports (PSURs), Drug Safety Update Reports (DSURs), and other safety related documents) in collaboration with Patient Safety
- Supports the Therapeutic Area Head (TAH) by providing medical input into IDP and CTP reviews and contributing/driving development of disease clinical standards for new disease areas. May take on other TA responsibilities as directed by the TAH
- As a medical expert, supports the (Sr.) GPCH or TAH in interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, data monitoring boards, advisory boards, patient advocacy groups), internal stakeholders (e.g., CTT, Research, Translational Medicine, Global Medical Affairs, Marketing, HE&OR), and internal decision boards
- May drive transition of pre-PoC (Proof of Concept) projects to DDP (Development Decision Point) and with BD&L (Business Development & Licensing) including target identification and due diligences together with other medical matters, as needed
- Ensures career development of Program reports and other clinical colleagues through active participation in the performance management and talent planning processes. Provides on-boarding, training, & mentoring support
- Contributes to medical/scientific training of relevant stakeholders on the disease area and compound/molecule. May serve as speaker for franchise medical/scientific training
- May serve on or lead global initiatives (e.g., process improvement, training, SOP development, other Clinical Development line function initiatives)
- May lead team of up to 5 reports (dependent on the size of the programs and functional responsibilities)
- Overall lifetime clinical budget of program which can vary and be in excess of $10 – 20 million.
- Timely submission and delivery of high quality clinical program data supporting regulatory approval of key compounds (or new indications), as appropriate
- Effective interaction with and influence on key external decision makers (e.g., regulatory authorities, medical experts, pricing and reimbursement bodies)
- Medically and scientifically sound programs and trials resulting in the timely delivery of high quality analysis of trial data which enables strategic decisions within the clinical program
- High quality clinical/scientific review of CTPs and CDPs, industry leading clinical processes
- Identification and development of key talent.
Qualifications and Experience:
- Relevant Swiss working/residency permit or Swiss/EU-Citizenship required
- MD or equivalent medical degree required;
- Advanced knowledge and clinical training in a medical/scientific area (e.g., internal medicine or sub-specialty) required, with Medical Board certification preferred; Clinical practice experience ≥ 4 years (including residency) preferred;
- ≥ 5 years of involvement in clinical research or drug development in an academic or industry environment spanning clinical activities in Phases I through IV. ≥ 3 years of contribution to and accomplishment in all aspects of conducting clinical trials (e.g., planning, executing, reporting and publishing) in a global/matrix environment in pharmaceutical industry;
- Deep understanding of the Oncology field, with a special emphasis on Breast Cancer;
- Demonstrated ability to establish strong scientific partnership with key stakeholders;
- Thorough knowledge of GCP, clinical trial design, statistical analysis methodology, and regulatory/ clinical development process;
- People management experience preferred, this may include management in a matrix environment. Global people management experience desirable;
- Excellent communication skills, written and oral;
- Strong interpersonal skills;
- Excellent negotiation and conflict resolution skills.
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