Senior Medical Director

2 months ago


UK, UK, United Kingdom BioTalent Full time

Senior Medical Director of Clinical Development


Position Overview:

We are seeking a highly qualified Senior Medical Director to join a progressive clinical-stage reproductive health company. The successful candidate will be responsible for providing strategic leadership and medical expertise in the design, execution, and interpretation of clinical trials, with a particular focus on women's health indications. They will play a pivotal role in shaping our clinical development strategy, driving the advancement of novel therapies.

Remote based in Europe, with travel.


Key Responsibilities:

  • Clinical Development Strategy: Develop and implement comprehensive clinical development plans for early phase trials in women's health indications, aligning with company objectives and regulatory requirements.
  • Study Design and Protocol Development: Lead the design and development of clinical trial protocols, ensuring scientific rigor, ethical standards, and alignment with regulatory guidelines.
  • Medical Oversight: Provide medical oversight and guidance throughout the lifecycle of clinical trials, including medical monitoring and support to safety surveillance.
  • Cross-functional Collaboration: Collaborate closely with cross-functional teams, including clinical discovery / translational science, regulatory affairs, pharmacovigilance, and biostatistics to ensure seamless execution of clinical programs.
  • Regulatory Interactions: Serve as a medical expert in interactions with regulatory agencies, including FDA, EMA, and others, providing clinical input and support for regulatory submissions.
  • Data Analysis and Interpretation: Analyse clinical trial data, interpret results, and contribute to the preparation of study reports, publications, and presentations for internal and external stakeholders.
  • KOL Engagement: Build and maintain relationships with key opinion leaders (KOLs), investigators, and academic institutions to stay abreast of scientific advancements and emerging trends in women's health.
  • Negotiations: Support the executive team in interactions with stakeholders, investors and fundraising.
  • Risk Management: Identify and mitigate clinical development risks, proactively addressing issues and ensuring compliance with regulatory requirements and industry standards.
  • Team Leadership and Mentoring: Provide leadership, guidance, and mentorship to junior medical and clinical development team members, fostering a culture of scientific excellence and professional growth



Qualifications:

  • Medical Doctor (MD) degree with board certification in a relevant therapeutic area (e.g., Obstetrics/Gynaecology, Internal Medicine, including, e.g., reproductive medicine, menopause, contraception, or gynaecological oncology, etc.).
  • Substantial experience in clinical development within the pharmaceutical or biotechnology industry, with a focus on early phase trials and women's health.
  • Proven track-record of authoring key technical and clinical documents, including but not limited to clinical study protocols, clinical study reports, investigator’s brochures, annual reports, and clinical sections of regulatory submissions.
  • Experience managing CROs, central laboratories, and other clinical study vendors
  • Act as medical monitor to clinical trial(s)
  • Proven track record of successful leadership and management of clinical development programs.
  • Strong understanding of clinical trial methodology, GCP guidelines, and regulatory requirements governing drug development in the EU and US.
  • Excellent communication skills, with the ability to effectively collaborate with internal and external stakeholders, including KOLs, investigators, and regulatory agencies (including attending FDA/EMA meetings).
  • Demonstrated strategic thinking, problem-solving ability, and decision-making skills in a fast-paced, dynamic environment.
  • Be able to provide clinical input to study teams on Case Report Form design, statistical analysis plans, monitoring guidelines, Data Review Plans, and Quality Management Plans as needed


  • Senior Medical Writer

    2 months ago


    UK, UK, United Kingdom Medical Talent Full time

    Is it time for a change? This Senior Medical Writer role working as part of a thriving HIV medical affairs team could be your perfect next step.Roles at this incredible agency don't come up often so this is a rare opportunity to join a forward-thinking, truly independent healthcare communications agency at SMW level.£47k-£55k plus bonus, market leading...


  • UK, UK, United Kingdom Medical Talent Full time

    This is a Principal Medical Writer role heading up a thriving publications account. Applicants must already have significant experience working at PMW level in a MedComms agency setting.Roles at this incredible agency don't come up often so this is a rare opportunity to join this forward-thinking, truly independent healthcare communications agency at...

  • Medical Director

    1 week ago


    UK, UK, United Kingdom Russell Tobin Full time

    Looking for a Medical Director, Renal - 12 months contract - £1000 per day (with leading pharmaceutical) About the jobSummaryThe Global Medical Affairs team acts as enterprise medical voice across the asset lifecycle and leads the medical strategy for the therapeutic area.Develops/ owns IEP and provides input into development while ensuring US and Int'l...

  • Medical Writer

    7 days ago


    UK, UK, United Kingdom Bounce Medical Communications Full time

    Medical writerLondon, England, United KingdomHybrid, Full-time, JuniorSkills: Medical Writing, Medical Communications, Scientific Writing, Medical Affairs, Commercial projects, Slide decks, Attention to Detail, Veeva, Pharmaceutical Companies, Target AudienceAbout the jobBounce is a dynamic, independent medical communications agency that pushes the...


  • UK, UK, United Kingdom Medical Talent Full time

    Are you a creative problem-solver with a passion for crafting engaging and strategic campaigns? Do you enjoy working closely with clients, becoming their trusted strategic partner?We have an exciting opportunity for a Senior Medical Copywriter at a top-tier healthcare advertising agency.What they can offer you;Supportive Environment: Ample opportunities for...

  • In House Counsel

    5 months ago


    UK, UK, United Kingdom The Legal Director Part time

    We are looking for UK-based senior business lawyers who are qualified in England & Wales with significant in-house experience and at least 10 years PQE.Selling legal services in a way that no-one else does, The Legal Director provides businesses with high-calibre, experienced lawyers on a part-time and/or flexible basis. The Legal Director is ideal if you...


  • UK, UK, United Kingdom Medical Talent Full time

    New opportunity for a strong client service professional to join a thriving creative healthcare advertising agency as Senior/Group Account Director. If you are not afraid to challenge the status quo, and you enjoy creating and delivering innovative projects, then this is the role for you!£70k-£100k (depending on level), with excellent benefits and...


  • UK, UK, United Kingdom Medical Talent Full time

    Are you an ambitious Project Manager or Senior Account Executive with a scientific background? Are you ready to take the next step in your career? This Scientific Project Manager role could be for you:- Independent MedComms agency where reward and recognition is key- Not a corporate environment - everyone is encouraged to contribute and share ideas- Part of...


  • UK, UK, United Kingdom Dynamic Talent Consulting Full time

    Senior Medical Writer – Medical Communications Position: Senior Medical WriterLocation: London (hybrid - 3 days in office)Contract Type: PermanentSalary: Up to £55k (dependent on experience)Start: ASAPSenior Medical Writer - This is an excellent opportunity to join a flourishing Editorial team! As a member of the scientific team, you will have the chance...


  • UK, UK, United Kingdom Helix Medical Recruitment Ltd Full time

    As a graduate Medical Sales Associate for a leading Orthopaedics medical device company, you’ll support surgeons and business growth in the East & West Midlands.Collaborate with senior medical sales colleagues to create, deliver and achieve the business plan to maintain and grow accounts and ensure customer satisfaction. Build and manage relationships with...


  • London, UK, UK, United Kingdom Medical Talent Full time

    **NEW ROLE** Exciting opportunity for a commercially astute Senior Account Director or ambitious, experienced AD to head up a well-established account team at a thriving global PR agency.Salary £65k-£75k with excellent benefits. This agency offers exceptional development and promotion opportunities - this is one NOT to miss! This is a hybrid role with 3...


  • ;Homeworking, , UK;Homeworking,, UK, United Kingdom Parexel Full time

    Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, and functional ability is underpinned by a deep...

  • Senior Medical Writer

    3 weeks ago


    UK, UK, United Kingdom Walker Cole International Full time

    Walker Cole International is seeking a Senior Medical Writer to work remotely for a European pharmaceutical company specializing in immunotherapy.In this role, you will support the Research and Development (R&D) department by handling all medical writing tasks.Your key responsibilities will include:Writing and developing essential clinical documents such as...

  • Senior Medical Writer

    2 weeks ago


    UK, UK, United Kingdom RiSE Scientific Full time

    SENIOR MEDICAL WRITERCompany info RiSE Scientific is a global independent medical education and communications agency, founded in 2022. Our mission is to raise the quality of healthcare provision by empowering scientific organisations to create impactful education through partnership with our flexible, trained and trusted team. We believe in creating...

  • Senior Strategist

    2 weeks ago


    London, UK, UK, United Kingdom Medical Talent Full time

    EXCITING NEW ROLEAre you an established healthcare strategist looking for your next challenge? Our client requires a self-starting, ambitious Senior Strategist/Associate Director, who is used to developing scientific strategy with minimal senior support, and adept at building partnerships with stakeholders.You must be proficient at interpreting and...

  • Medical Sales Manager

    1 month ago


    UK, UK, United Kingdom Progress Sales Recruitment Ltd Full time

    Medical Sales ManagerGlobal Medical Device Manufacturer, direct representation in over 34 countries and global reach through an expansive distribution network. Exceptional product portfolio that spans Orthopaedics, Infusion, Advanced Wound Care, Theatre Supplies, Surgical Solutions and Patient Hygiene. Offering fantastic career development opportunities and...


  • UK, UK, United Kingdom Langland Full time

    Director - Langland, Medical Communications2 Television Centre, 101 Wood Lane, London, W12 7FRCompany DescriptionLangland, a Publicis Health company, is the only health communications agency that thinks further across Clinical Trial Experience, Medical Strategy & Education, Public Relations & Policy, and Advertising, to create unique value with visionary...

  • Senior Medical Writer

    3 months ago


    UK, UK, United Kingdom Cognite Full time

    In the fast-changing world in which our clients seek to deliver life-changing medicines and technology, Cognite’s dynamic and forward-thinking team drives us in our mission of bringing science to life.As an independent agency, we develop innovative communications that convey science in the most effective and engaging way possible. Cultivating partnerships...


  • UK, UK, United Kingdom Planet Pharma Full time

    We are working with a Global Pharmaceutical Company who have multiple life changing Oncology products on the market and a strong pipeline of exciting drugs coming through. They are looking for an experienced Senior Medical Affairs Manager to join them to be focused on the execution of the Country Medical Affairs strategy.You would also work with other...


  • UK, UK, United Kingdom myGwork Full time

    This job is with Autolus Therapeutics, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly. Job Title: Senior Director, Patient Advocacy Reports to: SVP, Medical Affairs Department: Corporate – Medical Affairs Location: Remote About...