Job Engine: Medical Affairs

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Tuesday, 4 February 2025

Hiring At UK For Medical Affairs Department At Simbec-Orion

Atharva J February 04, 2025 0

ABOUT US

Our passion for improving patients’ lives motivates us to apply our skills, experience and knowledge to advance medicine.

We achieve this through flexible, innovative, high-quality solutions for our clients, delivered with integrity.

THE ROLE

We are looking for an Associate Medical Director to join our Medical-Clinical Pharmacology team. You will be responsible for ensuring that all projects are designed, executed, and delivered safely to meet clients' development needs while ensuring the safety and welfare of trial participants and data integrity within the Clinical Pharmacology Unit at all times.

You will ensure that all procedures are performed to acceptable Medical, Scientific and Ethical Standards and that all trials are run in accordance with protocols and standard operating procedures (SOPs) and meet all regulatory requirements and ICH-GCP. Responsible for the line management of the Research Physician team, sharing their knowledge and supporting the team's competency. You will also act as Principal Investigator on studies including First-in-Human Trials.

KEY ACCOUNTABILITIES

Ensure the safety and welfare of trial participants and the delivery of high-quality studies in the Clinical Pharmacology Unit, in accordance with Simbec-Orion's Quality Management System, ICH-GCP; MHRA Phase I accreditation requirements and The Independent Health Care (Wales) Regulations 2011 at all times.
Assess and develop key trial documents and reports (including study protocols, Risk Management Plans, study-specific training and safety reports) and advise/present on project safety, feasibility, and operationalisation internally and with clients.
Perform screening, ongoing monitoring and post-study clinical examinations (including review of ECGs, vital signs, Spirometry, Holter, Laboratory results and management and assessment of adverse events) and clinical procedures as appropriate to each study (cannulation, dosing procedures, nasogastric tubes, skin biopsy samples etc.); reporting any clinically significant abnormal results and/or changes from baseline and action taken to the designated Study Principal Investigator, Senior Medical Director and/or Sponsors.
Evaluate participant's eligibility and obtain written informed consent for inclusion in a specific study according to the information in the Investigator Brochure, Protocol and Informed Consent Document.
• Supports effective communication with volunteers' General Practitioners regarding their participation in a study, collaborative care and follow-up.
Act as a Principal Investigator (including First in Human) / Sub-Investigator for clinical trials to the highest standards, including actively participating in data review and taking responsibility for trial (including dose escalation) decisions, and liaison with hospital specialists, GPs, consultants and others to recruit suitable volunteers and patients for clinical trials.
Be proficient in Advanced Life Support and capable of dealing with acute medical emergencies that may arise in the Clinic Pharmacy Unit. Provide medical cover outside of normal working hours as part of an On-Call Rota.
Line Management of Research Physicians and provide leadership support and guidance to the Heads of Departments for the Clinic and Enrolment Services departments to fulfil their roles successfully; Deputise for the Senior Medical Director.
Participate in Commercial Development activities (including Feasibility assessment and Budget reviews when required) and take an active role in providing feasibility and strategic advice for proposal development at key client meetings and Bid Defence Meetings; Represent Simbec-Orion at national and international meetings/conferences seminars and workshops.
Collaborate and consult with others to develop and maintain strong working relationships with peers, senior leaders, and key stakeholders to ensure projects are delivered on schedule and within budget.

SKILLS REQUIRED

ESSENTIAL

Medical Degree with GMC Registered with a License to Practice and comply with revalidation requirements
Post-graduate Qualification in Clinical Pharmacology/Pharmaceutical Medicine (eligible to be First-in-Human Principal Investigator)
Experience in the conduct of Clinical Trials in a Clinical Pharmacology Unit
Experience as Principal Investigator of FiH studies, including significant experience in the interpretation of non-clinical data
Thorough understanding of MHRA Phase I Accreditation requirements
Excellent verbal and written skills, with the ability to tailor communication to various stakeholders
Experience managing participant safety (eligibility, ongoing review/assessment) and managing Medical Emergencies
Competent in MS Office Packages
Understanding and meeting the needs of clients and the business
Strong leadership, line management and teamwork skills

DESIRABLE

Valid Advanced Life Support (ALS) certificate from the Resuscitation Council (UK)
Previous Bio-Tech /Pharma Experience
Experience in leading cross-functional project/clinical teams
Competent in using Electronic Data Capturing Systems
Experience in business development activities, including feasibility and strategic advice for proposal development and bid-defence meetings
Experience with Clinical Trial Management Systems (CTMS)

WHY YOU SHOULD JOIN US

Simbec-Orion is a responsive and agile full-service CRO, delivering studies from first in man through to Phase III. Our experts leverage wide therapeutic experience and specialist expertise to execute a comprehensive portfolio of trials. We are perfectly structured to provide full-service clinical development solutions for small and mid-size drug developers, headed up by a centralised leadership team.

With a focus on tailormade and scalable solutions, we adapt our delivery style, communications and operations to suit the demands of the project, helping clients achieve their clinical and commercial objectives. Because our goal is the same as theirs; to improve patients’ lives.

Apply Here

Job Opportunities At Belgium For Medical Affairs At Astellas

Medical Affairs

Atharva J September 12, 2024 0

Lead, Therapeutic Area Specialty Medical Affairs - Benelux & Ireland

About Astellas:

At Astellas we are a progressive health partner, delivering value and outcomes where needed.

We pursue innovative science, focussing initially on the areas of greatest potential and then developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and conditions.

We work directly with patients, doctors and health care professionals on the front line to ensure patient and clinical needs are guiding our development activities at every stage.

Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn’t a buzzword - it’s a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division.

We work closely with regulatory authorities and payers to find new ways to ensure access to new therapies. We deliver the latest insights and real-world evidence to inform the best decisions for patients and their care-givers, to ensure the medicines we develop continue to provide meaningful outcomes.

Beyond medicines, we support our stakeholder communities to drive initiatives that improve awareness, education, access and ultimately standards of care.

The Opportunity:

As a Lead, Therapeutic Area Specialty (TAL) Medical Affairs - Benelux & Ireland, you will be responsible for the implementation of the medical strategy (Core Medical Plan) in the designated therapeutic area of Urology at the affiliate level by coordinating and executing medical and scientific activities to understand the local external environment and data gaps.

You will also translate insights into strategies and activities ensuring the information needs of key stakeholders are fulfilled to help ensure the safe and appropriate use of Astellas products.

Hybrid Working:

At Astellas we recognise the importance of balancing your work and home life, so we offer a hybrid working solution allowing time to connect with colleagues in person at the office alongside the flexibility to work from home; optimising the most productive work environment for you to succeed and deliver.

Key Responsibilities:

Provide strategic medical and scientific expertise in support of all affiliate’s Medical Affairs deliverables and cross-functional activities.
Demonstrate matrix leadership by developing and maintaining integrated partnerships with key internal and external stakeholders to ensure all MA affiliate activities address local needs and advance the medical/scientific understanding of Astellas products across their lifecycle.
Responsible for understanding and engaging external stakeholders to advance the knowledge and science behind compounds in developing, safe, and effective use of Astellas products, and disease states they treat.
Responsible for engaging and working closely with key internal stakeholders, including the brand teams across the affiliate to achieve business objectives for the affiliate.
Ensure all affiliate MA activities deliver value and are based on scientific validity, clinical importance, and on time & budget.

Essential Knowledge & Experience:

Previous experience in Pharma, preferably in Medical Affairs.
Suitable candidates from academia with strong expertise in the therapeutic area can be considered.
Native proficiency in Dutch or French and professional working proficiency in English or others.
Ability to travel 20-30% of the time including overnight travel.

Preferred Experience:

Cross-collaborative mindset, pro-active in supporting or creating business initiatives, strong networker (both internally and externally).
Excellent presentation skills.
Proactive strategic partnering with different internal functions.
Preferably a good understanding of the dynamics of a corporate environment and comfortable with matrix reporting lines.
Experience in the therapeutic area of Urology.
Knowledge and strong understanding of and ability to comply with industry laws and regulations.
Understanding of the drug development process as well as commercialization.

Education:

Master’s degree in health-related science or equivalent.
Preferably with MD or PhD in health-related science, PharmD or equivalent.

Additional Information:

This is a permanent, full-time position.
Position is based in Belgium and the Netherlands.
This position follows our hybrid working model. Role requires a blend of home and a minimum of 2 days per week in our Belgium or Netherlands offices. Flexibility may be required in line with business needs. Candidates must be located within a commutable distance of the office.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Apply Here